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RecruitingNCT04557449CDK4iUpdated Nov 10, 2026

Study to Test the Safety and Tolerability of PF-07220060 in Participants With Advance Solid Tumors

A Phase 2 interventional study of PF-07220060 and Letrozole in Liposarcoma, Prostate Cancer and Advanced Breast Cancer, sponsored by Pfizer. Recruiting at 39 sites in 8 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-10.

Sponsored by Pfizer · Phase 2, Interventional, and Treatment

From the registry’s dates

  • Started Sep 2020; still recruiting 6 years 1 month later.
Updated Nov 10, 2026Now RecruitingSite recruiting status changed+8 moreGo to Updates ↓
Phase
Phase 2
Study type
Interventional
Enrollment
430
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study summary

This is a Phase 1/2A, open label, multicenter, nonrandomized, multiple dose, safety, tolerability, pharmacokinetic and pharmacodynamic study of PF-07220060 administered as a single agent and in combination with endocrine therapy.

Part 1 includes dose escalation cohorts evaluating PF-07220060 as single agent or in combination with endocrine therapy or enzalutamide, as well as a food effect cohort and a DDI cohort.

Part 2 includes dose expansion cohorts evaluating PF-07220060 in combination with endocrine therapy or enzalutamide.

The Giredestrant Combination Cohort will evaluate PF-07220060 in combination with giredestrant.

In Part 1A, single escalating doses of PF-07220060 alone will be administered to determine the maximum tolerated dose (MTD) and select the recommended dose for expansion.

In Part 1B and Part 1C, PF-07220060 will be administered in combination with 1 of 2 endocrine therapies (letrozole and fulvestrant, respectively).

In Part 1D, food effect assessment of PF-07220060 at the RP2D dose level from Part 1A will be conducted.

In Part 1E, the effect of PF-07220060 on the PK of midazolam will be evaluated (DDI).

In Part 1F, escalating doses of PF-07220060 will be administered in combination with enzalutamide.

In Part 1G, PF-07220060 will be administered in combination with tamoxifen to determine the RDE.

Part 2A is an expansion cohort for PF-07220060 in combination with fulvestrant and will explore more than one dose of PF-07220060.

Part 2B and Part 2C are expansion cohorts for PF-07220060 in combination with letrozole and fulvestrant, respectively.

Part 2E is an expansion cohort to evaluate PF-07220060 Monotherapy versus PF-07220060 plus fulvestrant combination therapy.

Part 2F is an expansion cohort for PF-07220060 in combination with tamoxifen. The Giredestrant Combination Cohort Group A will determine the tolerable dose of PF-07220060 in combination with giredestrant. In Group B, additional participants will be enrolled at the tolerable dose to further assess safety and PK.

The China and Japan monotherapy cohorts will evaluate safety, tolerability, and PK of PF-07220060 as single agent in Chinese and Japanese participants, respectively.

02

Conditions studied

  • Liposarcoma
  • Prostate Cancer
  • Advanced Breast Cancer
  • NSCLC (Non-small Cell Lung Cancer)
  • Colorectal Cancer

Keywords

  • CDK4 inhibitor
  • Breast cancer
  • enzalutamide
  • fulvestrant
  • letrozole
  • endocrine therapy
  • Colorectal Cancer (CRC)
  • Solid Tumors
  • giredestrant
  • tamoxifen
03

In context

Liposarcoma

160 studies on the registry are indexed under Liposarcoma; 36 are open to participants now.

This study's planned enrollment of 430 is above the median of 52 across 136 interventional studies indexed under Liposarcoma.

Browse Liposarcoma studies →

Lead sponsor

Pfizer is the lead sponsor of 3,334 studies on the registry; 149 are open to participants now.

Of its 601 completed or terminated interventional studies of FDA-regulated products, 391 (65%) have results posted.

Browse Pfizer studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

The criteria were revised on the registry on Oct 21, 2026. See what changed

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Part 1: Breast Cancer (BC)

    • Hormone Receptor Positive (HR+), Human Epidermal Growth Factor Receptor 2 Negative (-) BC
    • Part 1A/Part 1D/Part 1E also include: Refractory HR-positive/HER2-positive BC
  • Part 1: Tumors other than BC (Part 1A/Part 1D/Part 1E): NSCLC, prostate, CRC, liposarcoma, or tumors with previously confirmed CDK4 or CCND1 amplification according to local standard tests
  • Part 1F: prostate cancer
  • Part 1G: HR-positive/HER2-negative BC
  • Part 2A, 2B, 2C, 2E, and 2F: HR-positive/HER2-negative BC
  • Part 1D: castration resistant prostate cancer
  • Giredestrant Combination Cohort: ER-positive/HER2-negative BC

  • Prior systemic Treatment

    • Part 1: HR-positive/HER2-negative BC

      • At least 1 line of SOC, including CD4/6 inhibitor therapy for advanced or metastatic disease, or if CDK4/6 inhibitors are not considered appropriate in the opinion of the investigator
      • HR-positive/HER2-positive BC (Parts 1A/1D/1E): at least 1 prior treatment of approved HER2 targeting therapy
      • Tumors other than BC (Parts 1A/1D/1E/1F): tumor that is resistant to at least 2 lines of SOC for advanced or recurrent disease or for which no standard therapy is available
    • Part 2A and 2E: at least 1 line of standard of care (including prior CDK4/6i) for advanced/metastatic disease; Prior chemo is allowed; Prior fulvestrant, mTOR and/or PI3K inhibitors are allowed
    • Part 2B: no prior systemic anti-cancer therapies for advanced/metastatic BC

    • Part 2C:

      • Progressed during treatment or within 12 months of completion of therapy with an aromatase inhibitor if , or tamoxifen if pre or perimenopausal, or
      • Progressed while on or within 1 month after the endo the prior aromatase inhibitor therapy for advanced/metastatic BC if postmenopausal or prior endocrine treatment for advanced/metastatic BC if pre or perimenopausal
      • One for advanced/metastatic disease is allowed in addition to endocrine therapy
    • Part 1G and 2F: at least 2 lines of SOC for advanced or metastatic disease, including CDK4/6 inhibitor and endocrine therapy
    • Giredestrant Combination Cohort: at least 1 (no more than 3) prior line(s) of SOC for advanced or metastatic disease, including CDK4/6 inhibitor and endocrine therapy

General Inclusion Criteria

  • All participants must be refractory to or intolerant of existing therapies known to provide clinical benefit for their condition.
  • (ECOG) Performance Status (PS) 0 or 1
  • Adequate renal, liver, and bone marrow function

Exclusion criteria

Exclusion Criteria:

  • Part 2B: prior or adjuvant treatment with a non-steroidal aromatase inhibitor with disease recurrence while on or within 12 months of completing treatment. Prior treatment with any CDK4/6 inhibitor
  • Part 2C: prior treatment with any CDK inhibitor, fulvestrant, everolimus, or any agent whose mechanism of action is to inhibit the PI3K-mTOR pathway
  • Known active uncontrolled or symptomatic Central Nervous System (CNS) carcinomatous meningitis, or
  • Other active within 3 years prior to randomization, except for adequately treated basal cell or squamous cell skin cancer, or carcinoma in situ
  • Major surgery or radiation within 4 weeks prior to study intervention
  • Last anti-cancer treatment within 2 weeks prior to study intervention; Part 1G and 2F: tamoxifen treatment within 35 days of Day -4
  • Participation in other studies involving drug(s) within 4 weeks prior to study entry
  • Part 1G and 2F: history of or current pulmonary embolism or deep vein thrombosis
  • Giredestrant Combination Cohort: history (within 6 months of screening) of or presence of idiopathic symptomatic bradycardia or resting heart rate \<50 bpm at screening
  • Pregnant or breastfeeding female participant
  • Active inflammatory gastrointestinal (GI) disease, known diverticular disease or previous gastric resection or lap band surgery including impairment of gastrointestinal function or GI disease
Terms in these criteria, in plain language(10)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Relapsed and refractory

Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.

HER2

HER2 is a protein, made from the ERBB2 gene, that drives the growth of some cancers. A study may look for a level of the protein, extra copies of the gene, or a particular change in it.

In breast cancer, protein tests are read as HER2-positive, HER2-low or HER2-negative; other cancers use their own rules. Check which test result the study requires.

Metastases

Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.

Adjuvant and neoadjuvant

Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.

Postmenopausal

Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).

Line of therapy

A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.

“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.

ECOG performance status

A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.

0
Fully active, no restrictions.
1
Limited in strenuous activity, but walking and able to do light work, such as housework or office work.
2
Walking and able to look after yourself, but unable to work; up and about more than half of waking hours.
3
Able to look after yourself only in part; in bed or a chair more than half of waking hours.
4
Unable to look after yourself at all; in bed or a chair all day.

Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.

Leptomeningeal disease

Cancer that has spread to the leptomeninges, the thin layers covering the brain and spinal cord, and the fluid between them. It is not the same as brain metastases.

Criteria often treat it separately, and many studies leave it out even where treated brain metastases are allowed.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Sequential assignment
Masking
None (open label)
Enrollment
430 participants (estimated)

Study arms

  • Experimental
    1A Monotherapy Escalation Arm 1

    PF-07220060 Monotherapy Escalation

    Drug: PF-07220060

  • Experimental
    1A Monotherapy Escalation Arm 2

    PF-07220060 Monotherapy Escalation

    Drug: PF-07220060

  • Experimental
    1A Monotherapy Escalation Arm 3

    PF-07220060 Monotherapy Escalation

    Drug: PF-07220060

  • Experimental
    1A Monotherapy Escalation Arm 4

    PF-07220060 Monotherapy Escalation

    Drug: PF-07220060

  • Experimental
    1A Monotherapy Escalation Arm 5

    PF-07220060 Monotherapy Escalation

    Drug: PF-07220060

  • Experimental
    1B Combination Dose Finding Arm 1

    PF-07220060 with Letrozole combination Escalation

    Drug: PF-07220060 · Combination Product: Letrozole

  • Experimental
    1B Combination Dose Finding Arm 2

    PF-07220060 with Letrozole Combination Escalation

    Drug: PF-07220060 · Combination Product: Letrozole

  • Experimental
    1C Combination Dose Finding Arm 1

    PF-07220060 with Fulvestrant Combination Escalation

    Drug: PF-07220060 · Combination Product: Fulvestrant

  • Experimental
    1C Combination Dose Finding Arm 2

    PF-07220060 with Fulvestrant Combination Escalation

    Drug: PF-07220060 · Combination Product: Fulvestrant

  • Experimental
    1D Monotherapy Food Effect

    PF-07220060 Monotherapy Food Effect

    Drug: PF-07220060

  • Other
    1E DDI Cohort

    PF-07220060 DDI with Midazolam

    Drug: PF-07220060 · Other: Midazolam

  • Experimental
    1F Combination Dose Finding

    PF-07220060 with Enzalutamide Escalation

    Drug: PF-07220060 · Combination Product: Enzalutamide

  • Experimental
    1G Combination Dose Finding Arm 1

    PF-07220060 with Tamoxifen Combination De-Escalation

    Drug: PF-07220060 · Combination Product: Tamoxifen

  • Experimental
    2A Combination Dose Expansion

    PF-07220060 with fulvestrant combination expansion

    Drug: PF-07220060 · Combination Product: Fulvestrant

  • Experimental
    2B Combination Dose Expansion

    PF-07220060 with Letrozole Combination Expansion

    Drug: PF-07220060 · Combination Product: Letrozole

  • Experimental
    2C Combination Dose Expansion

    PF-07220060 with fulvestrant Combination Expansion

    Drug: PF-07220060 · Combination Product: Fulvestrant

  • Experimental
    2E Combination Dose Expansion

    PF-07220060 Monotherapy OR PF-07220060 plus fulvestrant combination therapy

    Drug: PF-07220060 · Combination Product: Fulvestrant

  • Experimental
    2F Combination Dose Expansion

    PF-07220060 with Tamoxifen Combination Expansion

    Drug: PF-07220060 · Combination Product: Tamoxifen

  • Experimental
    Giredestrant Combination Cohort (Group A)

    PF-07220060 with Giredestrant Combination

    Drug: PF-07220060 · Combination Product: Giredestrant

  • Experimental
    Giredestrant Combination Cohort (Group B)

    PF-07220060 with Giredestrant Combination

    Drug: PF-07220060 · Combination Product: Giredestrant

Interventions

  • DrugPF-07220060

    CDK4 inhibitor

  • Combination productLetrozole

    Endocrine Therapy

    Also known as: Femara

  • Combination productFulvestrant

    Endocrine Therapy

    Also known as: Faslodex

  • OtherMidazolam

    Benzodiazepine

  • Combination productEnzalutamide

    Androgen Receptor inhibitor

    Also known as: Xtandi

  • Combination productGiredestrant

    Endocrine Therapy

  • Combination productTamoxifen

    Endocrine Therapy

06

What researchers measure

Primary outcomes

  1. Number of participants with dose limiting toxicities in the Dose Escalation or De-escalation Portion

    First cycle (28 days) dose limiting toxicities

    Time frame: At the end of Cycle 1 (each cycle is 28 days)

  2. Incidence of clinically significant AEs

    Adverse Events

    Time frame: Cycle 1 (each cycle is 28 days) through study completion, up to approximately 24 months

  3. Incidence of clinically significant laboratory assessments

    safety laboratory abnormalities

    Time frame: Cycle 1 (each cycle is 28 days) through study completion, up to approximately 24 months

  4. Incidence of clinically significant abnormal vital and ECG parameters

    vital signs and heart rate corrected QT interval

    Time frame: Cycle 1 (each cycle is 28 days) through study completion, up to approximately 24 months

  5. Maximal Plasma Concentration (Cmax) of PF-07220060 given with and without food

    Pharmacokinetic (PK) assessments for PF-07220060 (Part 1D)

    Time frame: Cycle 1 (each cycle is 28 days)

  6. Time to Maximum Plasma Concentration (Tmax) of PF-07220060 given with and without food

    Pharmacokinetic (PK) assessments for PF-07220060 (Part 1D)

    Time frame: Cycle 1 (each cycle is 28 days)

  7. Area Under the Plasma Concentration Versus Time Curve from Time Zero to the Last Sampling Time Point (AUClast) of PF-07220060 given with and without food

    Pharmacokinetic (PK) assessments for PF-07220060 (Part 1D)

    Time frame: Cycle 1 (each cycle is 28 days)

  8. Maximal Plasma Concentration (Cmax) of Midazolam with and without PF-07220060

    Pharmacokinetic (PK) assessments for PF-07220060 (Part 1E)

    Time frame: Cycle 1 (each cycle is 28 days)

  9. Time to Maximum Plasma Concentration (Tmax) of Midazolam with and without PF-07220060

    Pharmacokinetic (PK) assessments for PF-07220060 (Part 1E)

    Time frame: Cycle 1 (each cycle is 28 days)

  10. Area Under the Plasma Concentration Versus Time Curve from Time Zero to the Last Sampling Timepoint (AUClast) of Midazolam with and without PF-07220060

    Pharmacokinetic (PK) assessments for PF-07220060 (Part 1E)

    Time frame: Cycle 1 (each cycle is 28 days)

  11. Steady State Maximal Concentration (Cmax,ss) of PF-07220060

    Pharmacokinetic (PK) assessments for PF-07220060 (Giredestrant Combination Cohort)

    Time frame: Cycle 1 (each cycle is 28 days)

  12. Steady State Time to Maximum Plasma Concentration (Tmax,ss) of PF-07220060

    Pharmacokinetic (PK) assessments for PF-07220060 (Giredestrant Combination Cohort)

    Time frame: Cycle 1 (each cycle is 28 days)

  13. Steady State Area Under the Plasma Concentration Versus Time Curve Within One Dose Interval (AUCτ,ss) of PF-07220060

    Pharmacokinetic (PK) assessments for PF-07220060 (Giredestrant Combination Cohort)

    Time frame: Cycle 1 (each cycle is 28 days)

  14. Steady State Minimum Plasma Concentration (Cmin,ss) of PF-07220060

    Pharmacokinetic (PK) assessments for PF-07220060 (Giredestrant Combination Cohort)

    Time frame: Cycle 1 (each cycle is 28 days)

  15. Steady State Maximal Concentration (Cmax,ss) of Giredestrant

    Pharmacokinetic (PK) assessments (Giredestrant Combination Cohort)

    Time frame: Cycle 1 (each cycle is 28 days)

  16. Steady State Time to Maximum Plasma Concentration (Tmax,ss) of Giredestrant

    Pharmacokinetic (PK) assessments (Giredestrant Combination Cohort)

    Time frame: Cycle 1 (each cycle is 28 days)

  17. Steady State Area Under the Plasma Concentration Versus Time Curve Within One Dose Interval (AUCτ,ss) of Giredestrant

    Pharmacokinetic (PK) assessments (Giredestrant Combination Cohort)

    Time frame: Cycle 1 (each cycle is 28 days)

  18. Steady State Minimum Plasma Concentration (Cmin,ss) of Giredestrant

    Pharmacokinetic (PK) assessments (Giredestrant Combination Cohort)

    Time frame: Cycle 1 (each cycle is 28 days)

Secondary outcomes

  1. Single Dose: Maximal Plasma Concentration (Cmax) in the Dose Escalation and Dose Finding portion

    Pharmacokinetic (PK) assessments for PF-07220060 (Parts 1A, 1B, 1C, 1F)

    Time frame: Cycle 1 (each cycle is 28 days)

  2. Single Dose: Time to Maximum Plasma Concentration (Tmax) in the Dose Escalation and Dose Finding portion

    Pharmacokinetic (PK) assessments for PF-07220060 (Parts 1A, 1B, 1C, 1F)

    Time frame: Cycle 1 (each cycle is 28 days)

  3. Single Dose: Area Under the Plasma Concentration Versus Time Curve from Time Zero to the Last Sampling Time Point Within the Dose Interval (AUClast) in the Dose Escalation and Dose Finding portion

    Pharmacokinetic (PK) assessments for PF-07220060 (Parts 1A, 1B, 1C, 1F)

    Time frame: Cycle 1 (each cycle is 28 days)

  4. Multiple Dose: Steady State Maximal Concentration (Cmax,ss) in the Dose Escalation and Dose Finding portion

    Pharmacokinetic (PK) assessments for PF-07220060 (Parts 1A, 1B, 1C, 1E, 1F, 1G)

    Time frame: Cycle 1 (each cycle is 28 days) for Parts 1A/1B/1C/1E/1F; Cycle 2 (each cycle is 28 days) for Part 1G

  5. Multiple Dose: Steady State Time to Maximum Plasma Concentration (Tmax,ss) in the Dose Escalation and Dose Finding portion

    Pharmacokinetic (PK) assessments for PF-07220060 (Parts 1A, 1B, 1C, 1E, 1F, 1G)

    Time frame: Cycle 1 (each cycle is 28 days) for Parts 1A/1B/1C/1E/1F; Cycle 2 (each cycle is 28 days) for Part 1G

  6. Steady State Area Under the Plasma Concentration Versus Time Curve Within One Dose Interval (AUCt,ss) in the Dose Escalation and Dose Finding portion

    Pharmacokinetic (PK) assessments for PF-07220060 (Parts 1A, 1B, 1C, 1E, 1F, 1G)

    Time frame: Cycle 1 (each cycle is 28 days) for Parts 1A/1B/1C/1E/1F; Cycle 2 (each cycle is 28 days) for Part 1G

  7. Multiple Dose: Steady State Minimum Plasma Concentration (Cmin,ss) in the Dose Escalation and Dose Finding portion

    Pharmacokinetic (PK) assessments for PF-07220060 (Parts 1A, 1B, 1C, 1E, 1F, 1G)

    Time frame: Cycle 1 (each cycle is 28 days) for Parts 1A/1B/1C/1E/1F; Cycle 2 (each cycle is 28 days) for Part 1G

  8. Steady State Peak Concentration of Enzalutamide and N-desmethyl Enzalutamide

    Pharmacokinetic (PK) assessments for enzalutamide (Part 1F)

    Time frame: Cycles 1 - 12 (each cycle is 28 days)

  9. Steady State Trough Concentration of Enzalutamide and N-desmethyl Enzalutamide

    Pharmacokinetic (PK) assessments for enzalutamide (Part 1F)

    Time frame: Cycle 3 (each cycle is 28 days)

  10. Tumor Response per RECIST v1.1 and per PCGW3

    Per RECIST v1.1 (all cohorts except for Part 1F); per PCWG3 (Part 1F)

    Time frame: baseline up to approximately 24 months

  11. Duration of Response (DOR)

    Per RECIST v1.1

    Time frame: baseline up to approximately 24 months

  12. Progression Free Survival (PFS)

    PFS per RECIST v.1.1

    Time frame: baseline up to approximately 24 months

  13. Clinical Benefit Rate (CBR)

    CBR per RECIST v1.1

    Time frame: baseline up to approximately 24 months

  14. PSA50

    Part 1F

    Time frame: Cycle 1 (each cycle is 28 days) through study completion, up to approximately 24 months

  15. Incidence of clinically significant AEs

    Adverse Events (Giredestrant Combination Cohort)

    Time frame: Cycle 1 (each cycle is 28 days) through study completion, up to approximately 24 months

  16. Incidence of clinically significant laboratory assessments

    Safety laboratory abnormalities (Giredestrant Combination Cohort)

    Time frame: Cycle 1 (each cycle is 28 days) through study completion, up to approximately 24 months

  17. Steady State Minimal Concentration (Cmin,ss) of Tamoxifen, 4-hydroxy-tamoxifen, N-desmethyltamoxifen, and Endoxifen

    Pharmacokinetic (PK) assessments for tamoxifen and metabolites (Parts 1G and 2F)

    Time frame: Cycle 2 (each cycle is 28 days)

  18. Metabolite to Parent Ratio of Minimal Concentration (MRCmin) of 4-hydroxy-tamoxifen, N-desmethyltamoxifen, and Endoxifen

    Pharmacokinetic (PK) assessments for tamoxifen and metabolites (Parts 1G and 2F)

    Time frame: Cycle 2 (each cycle is 28 days)

  19. Steady State Area Under the Plasma Concentration Versus Time Curve Within One Dose Interval (AUCt,ss) of Tamoxifen, 4-hydroxy-tamoxifen, N-desmethyltamoxifen, and Endoxifen

    Pharmacokinetic (PK) assessments for tamoxifen and metabolites (Parts 1G and 2F)

    Time frame: Cycle 2 (each cycle is 28 days)

  20. Steady State Peak Concentration of PF-07220060

    Pharmacokinetic (PK) assessments for PF-07220060 (Part 2A, 2B, 2C, 2E, 2F)

    Time frame: Cycle 1 (each cycle is 28 days) for Part 2A/2B/2C/2E; Cycle 2 (each cycle is 28 days) for Part 2F

  21. Steady State Trough Concentration of PF-07220060

    Pharmacokinetic (PK) assessments for PF-07220060 (Parts 2A, 2B, 2C, 2E, 2F)

    Time frame: Cycle 1 (each cycle is 28 days) for Parts 2A/2B/2C/2E; Cycle 2 (each cycle is 28 days) for Part 2F

07

Study locations

11 of 39 sites recruiting
  • Ellison Institute
    Los Angeles, California 90064, United States
    Recruiting
  • Smilow Cancer Hospital - Yale New Haven Health
    New Haven, Connecticut 06510, United States
    Recruiting
  • Yale-New Haven Hospital-Yale Cancer Center
    New Haven, Connecticut 06510, United States
    Recruiting
  • Smilow Cancer Hospital Phase 1 Unit
    New Haven, Connecticut 06511, United States
    Recruiting
  • Yale University - Smilow Cancer Hospital; C/O Thomas Ferencz, RPh, BCOP
    New Haven, Connecticut 06511, United States
    Recruiting
  • Smilow Cancer Hospital - Trumbull
    Trumbull, Connecticut 06611, United States
    Recruiting
  • Brigham & Women's Hospital
    Boston, Massachusetts 02115, United States
    Active, not recruiting

    Not enrolling at this site — choose another above.

  • Dana-Farber Cancer Institute
    Boston, Massachusetts 02215, United States
    Active, not recruiting

    Not enrolling at this site — choose another above.

  • Dana Farber Cancer Institute- Chestnut Hill
    Newton, Massachusetts 02467, United States
    Active, not recruiting

    Not enrolling at this site — choose another above.

  • START Midwest
    Grand Rapids, Michigan 49546, United States
    Recruiting
  • Sarah Cannon Research Institute - Pharmacy
    Nashville, Tennessee 37203, United States
    Recruiting
  • SCRI Oncology Partners
    Nashville, Tennessee 37203, United States
    Recruiting
  • The University of Texas MD Anderson Cancer Center
    Houston, Texas 77030, United States
    Recruiting
  • The University of Texas, MD Anderson Cancer Center - West Houston
    Houston, Texas 77079, United States
    Recruiting
  • Hospital Británico de Buenos Aires
    Ciudad Autónoma de Buenos Aires, Buenos Aires 1280, Argentina
    Active, not recruiting

    Not enrolling at this site — choose another above.

  • Fundación Cenit Para La Investigación En Neurociencias
    CABA, Ciudad Autã³noma de Buenos Aires 1125, Argentina
    Active, not recruiting

    Not enrolling at this site — choose another above.

  • Fundación Respirar
    Buenos Aires, C1426ABP, Argentina
    Active, not recruiting

    Not enrolling at this site — choose another above.

  • Clínica Universitaria Reina Fabiola
    Córdoba, X50004FHP, Argentina
    Active, not recruiting

    Not enrolling at this site — choose another above.

  • Fundación CORI para la Investigación y Prevención del Cáncer
    La Rioja, F5300COE, Argentina
    Active, not recruiting

    Not enrolling at this site — choose another above.

  • Cancer Hospital Chinese Academy of Medical Science
    Beijing, Beijing Municipality 100021, China
    Active, not recruiting

    Not enrolling at this site — choose another above.

  • Henan Cancer Hospital
    Zhengzhou, Henan 450008, China
    Active, not recruiting

    Not enrolling at this site — choose another above.

  • Hubei Cancer Hospital
    Wuhan, Hubei 430079, China
    Active, not recruiting

    Not enrolling at this site — choose another above.

  • The First Affiliated Hospital of Xi'an Jiaotong University
    Xi’an, Shanxi 710061, China
    Active, not recruiting

    Not enrolling at this site — choose another above.

  • Sir Run Run Shaw Hospital, Zhejiang University School of Medicine
    Hangzhou, Zhejiang 310016, China
    Active, not recruiting

    Not enrolling at this site — choose another above.

  • Vseobecna fakultni nemocnice v Praze
    Prague, 12808, Czechia
    Active, not recruiting

    Not enrolling at this site — choose another above.

  • National Cancer Center Hospital East
    Kashiwa, Chiba 277-8577, Japan
    Active, not recruiting

    Not enrolling at this site — choose another above.

  • COI Centro Oncologico Internacional S.A.P.I. de C.V.
    Mexico City, Mexico City 04700, Mexico
    Active, not recruiting

    Not enrolling at this site — choose another above.

  • Hospital MAC Periferico Sur
    Mexico City, Mexico City 04700, Mexico
    Active, not recruiting

    Not enrolling at this site — choose another above.

  • INCAN
    Mexico City, Mexico City 14080, Mexico
    Active, not recruiting

    Not enrolling at this site — choose another above.

  • Hospital Universitario "Dr. Jose Eleuterio Gonzalez"
    Monterrey, Nuevo León 64460, Mexico
    Active, not recruiting

    Not enrolling at this site — choose another above.

  • Hospital Reforma
    Oaxaca City, Oaxaca 68000, Mexico
    Active, not recruiting

    Not enrolling at this site — choose another above.

  • Oaxaca Site Management Organization
    Oaxaca City, 68000, Mexico
    Active, not recruiting

    Not enrolling at this site — choose another above.

  • Onkologicky ustav sv. Alzbety, s.r.o., Interna klinika VSZaSP a OUSA
    Bratislava, 812 50, Slovakia
    Active, not recruiting

    Not enrolling at this site — choose another above.

  • Narodny onkologicky ustav
    Bratislava, 833 10, Slovakia
    Active, not recruiting

    Not enrolling at this site — choose another above.

  • Fakultna nemocnica s poliklinikou Nove Zamky
    Nové Zámky, 940 34, Slovakia
    Active, not recruiting

    Not enrolling at this site — choose another above.

  • Cancer Research UK Edinburgh Centre
    Edinburgh, Edinburgh, CITY of EH4 2XR, United Kingdom
    Active, not recruiting

    Not enrolling at this site — choose another above.

  • St Bartholomew's Hospital
    London, London, CITY of EC1A 7BE, United Kingdom
    Active, not recruiting

    Not enrolling at this site — choose another above.

  • Sarah Cannon Research Institute UK
    London, W1G 6AD, United Kingdom
    Active, not recruiting

    Not enrolling at this site — choose another above.

  • The Christie Hospital NHS Foundation Trust
    Manchester, M20 4BX, United Kingdom
    Active, not recruiting

    Not enrolling at this site — choose another above.

08

References and documents

Publications

  • Safaroghli-Azar A, Mekonnen LB, Lenjisa J, Milne R, Wang S. Cell-cycle targeted cancer therapy: clinical advances, biological gaps, and the emergence of selective CDK4 inhibitors. J Hematol Oncol. 2026 Apr 6;19(1):31. doi: 10.1186/s13045-026-01794-7. PubMed 41943159 ↗

Individual participant data

Plan to share: Yes — Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

Data sharing details ↗ · www.pfizer.com

09

Timeline

3 registry updates since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedDate before it movedWhere the date was before it movedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Sep 2020 (actual). Primary completion is estimated for Oct 2029, 108 months after the start.

Of 35 phase 2 interventional studies under Liposarcoma, half reached primary completion within 73 months of starting (the median), counting those still running; a quarter within 38 and three quarters within 94. This study's planned 108 months is above that.

Since we started tracking on Sep 25, 2026, the dates moved once, on Oct 21, 2026: primary completion Sep 2026 → Oct 2029 and completion Nov 2027 → Oct 2029.

Earlier changes are on the record history on ClinicalTrials.gov ↗

How these figures are worked out, and which studies are left out of them.

Registered
Sep 15, 2020
First posted
Sep 21, 2020
StartActual
Sep 23, 2020
Primary completionEst.
Oct 7, 2029was Sep 2026
CompletionEst.
Oct 7, 2029was Nov 2027
Last update
Nov 10, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Status
Active, not recruiting→Recruiting
changed Oct 21, 2026
Sites
39 sites changed recruiting status (28 now active, not recruiting, 11 now recruiting)
Show 39 sites
  • Ellison Institute · Los Angeles, United Statesno status→Recruiting
  • Smilow Cancer Hospital - Yale New Haven Health · New Haven, United Statesno status→Recruiting
  • Yale-New Haven Hospital-Yale Cancer Center · New Haven, United Statesno status→Recruiting
  • Smilow Cancer Hospital Phase 1 Unit · New Haven, United Statesno status→Recruiting
  • Yale University - Smilow Cancer Hospital; C/O Thomas Ferencz, RPh, BCOP · New Haven, United Statesno status→Recruiting
  • Smilow Cancer Hospital - Trumbull · Trumbull, United Statesno status→Recruiting
  • Brigham & Women's Hospital · Boston, United Statesno status→Active, not recruiting
  • Dana-Farber Cancer Institute · Boston, United Statesno status→Active, not recruiting
  • Dana Farber Cancer Institute- Chestnut Hill · Newton, United Statesno status→Active, not recruiting
  • START Midwest · Grand Rapids, United Statesno status→Recruiting
  • Sarah Cannon Research Institute - Pharmacy · Nashville, United Statesno status→Recruiting
  • SCRI Oncology Partners · Nashville, United Statesno status→Recruiting
  • The University of Texas MD Anderson Cancer Center · Houston, United Statesno status→Recruiting
  • The University of Texas, MD Anderson Cancer Center - West Houston · Houston, United Statesno status→Recruiting
  • Hospital Británico de Buenos Aires · Ciudad Autónoma de Buenos Aires, Argentinano status→Active, not recruiting
  • Fundación Cenit Para La Investigación En Neurociencias · CABA, Argentinano status→Active, not recruiting
  • Fundación Respirar · Buenos Aires, Argentinano status→Active, not recruiting
  • Clínica Universitaria Reina Fabiola · Córdoba, Argentinano status→Active, not recruiting
  • Fundación CORI para la Investigación y Prevención del Cáncer · La Rioja, Argentinano status→Active, not recruiting
  • Cancer Hospital Chinese Academy of Medical Science · Beijing, Chinano status→Active, not recruiting
  • Henan Cancer Hospital · Zhengzhou, Chinano status→Active, not recruiting
  • Hubei Cancer Hospital · Wuhan, Chinano status→Active, not recruiting
  • The First Affiliated Hospital of Xi'an Jiaotong University · Xi’an, Chinano status→Active, not recruiting
  • Sir Run Run Shaw Hospital, Zhejiang University School of Medicine · Hangzhou, Chinano status→Active, not recruiting
  • Vseobecna fakultni nemocnice v Praze · Prague, Czechiano status→Active, not recruiting
  • National Cancer Center Hospital East · Kashiwa, Japanno status→Active, not recruiting
  • COI Centro Oncologico Internacional S.A.P.I. de C.V. · Mexico City, Mexicono status→Active, not recruiting
  • Hospital MAC Periferico Sur · Mexico City, Mexicono status→Active, not recruiting
  • INCAN · Mexico City, Mexicono status→Active, not recruiting
  • Hospital Universitario "Dr. Jose Eleuterio Gonzalez" · Monterrey, Mexicono status→Active, not recruiting
  • …and 9 more on the registry record
across 2 updates, Oct 21, 2026 – Nov 10, 2026
Primary completion
Sep 23, 2026→Oct 7, 2029
Oct 21, 2026
Study completion
Nov 23, 2027→Oct 7, 2029
Oct 21, 2026
Enrollment
362 (actual)→430 (estimated)
Oct 21, 2026
Eligibility
5 inclusion criteria edited, 4 added, 9 removed; 1 exclusion criterion edited, 2 added, 1 removed
What changed in the criteria
Inclusion criteria
  • EditedPart 1A/Part 1D/Part1EPart 1E also include: Refractory HR-positive/HER2-positive BC
  • EditedPart 1G: HR-positive/HER2-negative BC
  • RemovedPatients who are either postmenopausal women or pre/peri-menopausal (Part 2C only)
  • EditedPart 2A, 2B, 2C, 2E, and 2E2F: HR-positive/HER2-negative BC
  • RemovedLesion:
  • RemovedPart 1: evaluable lesion (including skin or bone lesion only)
  • RemovedPart 2A, 2B, 2C and 2E: measurable lesion per RECIST v1.1
  • RemovedPart 2D: Participants with evaluable disease as per PCWG3; participants with bone metastases only are allowed. Participants with biochemical recurrence only are excluded.
  • AddedGiredestrant Combination Cohort: ER-positive/HER2-negative BC
  • RemovedAt least 1 line of anti-endocrine in countries without CDK4/6 inhibitor approval or reimbursement, for advanced or metastatic disease
  • EditedPart 2A and 2E: participants must have received at least 1 line of standard of care (including prior CDK4/6i) for advanced/metastatic disease; Prior chemo is allowed; Prior fulvestrant, mTOR and/or PI3K inhibitors are allowed
  • EditedPart 2B: participants who have not received anyno prior systemic anti-cancer therapies for advanced/metastatic BC
  • RemovedPart 2D:
  • RemovedReceived prior abiraterone; enzalutamide and CDK4i naive
  • Removed0-1 line of chemotherapy is allowed General Inclusion Criteria
  • AddedPart 1G and 2F: at least 2 lines of SOC for advanced or metastatic disease, including CDK4/6 inhibitor and endocrine therapy
  • AddedGiredestrant Combination Cohort: at least 1 (no more than 3) prior line(s) of SOC for advanced or metastatic disease, including CDK4/6 inhibitor and endocrine therapy
  • AddedGeneral Inclusion Criteria
Exclusion criteria
  • RemovedPart 1D: participants who have had a gastrectomy or have dietary or other restrictions that preclude a 10 hour overnight fast or consumption of the high fat, high calorie meal
  • EditedLast anti-cancer treatment within 2 weeks prior to study intervention; Part 1G and 2F: tamoxifen treatment within 35 days of Day -4
  • AddedPart 1G and 2F: history of or current pulmonary embolism or deep vein thrombosis
  • AddedGiredestrant Combination Cohort: history (within 6 months of screening) of or presence of idiopathic symptomatic bradycardia or resting heart rate <50 bpm at screening
Oct 21, 2026
Interventions
Added Midazolam·Combination product: Giredestrant·Combination product: Tamoxifen; removed Drug: Midazolam. Arm changed 2D Combination Dose Expansion→2F Combination Dose Expansion. Arms added: 1G Combination Dose Finding Arm 1·Giredestrant Combination Cohort (Group A)·Giredestrant Combination Cohort (Group B)
Oct 21, 2026
Primary outcomes
1 edited, 3 time frame changed, 14 added, 2 removed
What changed in the outcomes
  • EditedNumber of participants with dose limiting toxicities in the Dose Escalation or De-escalation PortionTime frame: Baseline up to day 28 of Cycle 1. → At the end of Cycle 1 (each cycle is 28 days)
  • AddedMaximal Plasma Concentration (Cmax) of PF-07220060 given with and without foodTime frame: Cycle 1 (each cycle is 28 days)
  • AddedTime to Maximum Plasma Concentration (Tmax) of PF-07220060 given with and without foodTime frame: Cycle 1 (each cycle is 28 days)
  • AddedArea Under the Plasma Concentration Versus Time Curve from Time Zero to the Last Sampling Time Point (AUClast) of PF-07220060 given with and without foodTime frame: Cycle 1 (each cycle is 28 days)
  • AddedMaximal Plasma Concentration (Cmax) of Midazolam with and without PF-07220060Time frame: Cycle 1 (each cycle is 28 days)
  • AddedTime to Maximum Plasma Concentration (Tmax) of Midazolam with and without PF-07220060Time frame: Cycle 1 (each cycle is 28 days)
  • AddedArea Under the Plasma Concentration Versus Time Curve from Time Zero to the Last Sampling Timepoint (AUClast) of Midazolam with and without PF-07220060Time frame: Cycle 1 (each cycle is 28 days)
  • AddedSteady State Maximal Concentration (Cmax,ss) of PF-07220060Time frame: Cycle 1 (each cycle is 28 days)
  • AddedSteady State Time to Maximum Plasma Concentration (Tmax,ss) of PF-07220060Time frame: Cycle 1 (each cycle is 28 days)
  • AddedSteady State Area Under the Plasma Concentration Versus Time Curve Within One Dose Interval (AUCτ,ss) of PF-07220060Time frame: Cycle 1 (each cycle is 28 days)
  • AddedSteady State Minimum Plasma Concentration (Cmin,ss) of PF-07220060Time frame: Cycle 1 (each cycle is 28 days)
  • AddedSteady State Maximal Concentration (Cmax,ss) of GiredestrantTime frame: Cycle 1 (each cycle is 28 days)
  • AddedSteady State Time to Maximum Plasma Concentration (Tmax,ss) of GiredestrantTime frame: Cycle 1 (each cycle is 28 days)
  • AddedSteady State Area Under the Plasma Concentration Versus Time Curve Within One Dose Interval (AUCτ,ss) of GiredestrantTime frame: Cycle 1 (each cycle is 28 days)
  • AddedSteady State Minimum Plasma Concentration (Cmin,ss) of GiredestrantTime frame: Cycle 1 (each cycle is 28 days)
  • RemovedFood EffectTime frame: Day -7 through the end of Cycle 1
  • RemovedDDITime frame: D1 to the end of Cycle 1
  • Time frameIncidence of clinically significant AEsWeekly during Cycle 1 and 2 and then every 28 days through study completion, up to approximately 24 months; Each cycle is 28 days → Cycle 1 (each cycle is 28 days) through study completion, up to approximately 24 months
  • Time frameIncidence of clinically significant laboratory assessmentsWeekly during Cycle 1 and 2 (each cycle is 28 days) and then every 28 days through study completion, up to approximately 24 months → Cycle 1 (each cycle is 28 days) through study completion, up to approximately 24 months
  • Time frameIncidence of clinically significant abnormal vital and ECG parametersDay 1, Day 8, Day 15 of Cycle 1 and starting from Cycle 2, and then every 28 days through study completion, up to approximately 24 months (Each cycle is 28 days) → Cycle 1 (each cycle is 28 days) through study completion, up to approximately 24 months
Oct 21, 2026
Publications
1 publication citing this study linked from PubMed, e.g. PubMed 41943159 ↗
Nov 10, 2026
Secondary outcomes
8 edited, 3 time frame changed, 6 added, 10 removed, 3 description edited, 2 more
What changed in the outcomes
  • EditedSingle Dose: Maximal concentrationPlasma Concentration (Cmax) in the Dose Escalation and Dose Finding portionTime frame: Cycle 1 (each cycle is 28 days) and Day 1 of each subsequent cycle and at study completion visit, up to approximately 24 months → Cycle 1 (each cycle is 28 days)
  • EditedSingleMultiple Dose: Area Under the PlasmaSteady State Maximal Concentration Versus Time Curve from Time Zero Extrapolated to Infinity (AUCinfCmax,ss) in the Dose Escalation and Dose Finding portionTime frame: Time Frame: Cycle 1 (each cycle is 28 days) and Day 1 of each subsequent cycle and at study completion visit, up to approximately 24 months → Cycle 1 (each cycle is 28 days) for Parts 1A/1B/1C/1E/1F; Cycle 2 (each cycle is 28 days) for Part 1G
  • EditedApparent OralMultiple Dose: Steady State Time to Maximum Plasma ClearanceConcentration (CL/FTmax,ss) in the Dose Escalation and Dose Finding portionTime frame: Cycle 1 (each cycle is 28 days) and Day 1 of each subsequent cycle and at study completion visit, up to approximately 24 months → Cycle 1 (each cycle is 28 days) for Parts 1A/1B/1C/1E/1F; Cycle 2 (each cycle is 28 days) for Part 1G
  • EditedSingleMultiple Dose: Apparent Volume of DistributionSteady State Minimum Plasma Concentration (Vz/FCmin,ss) in the Dose Escalation and Dose Finding portionTime frame: Cycle 1 (each cycle is 28 days) and Day 1 of each subsequent cycle and at study completion visit, up to approximately 24 months → Cycle 1 (each cycle is 28 days) for Parts 1A/1B/1C/1E/1F; Cycle 2 (each cycle is 28 days) for Part 1G
  • EditedMultiple Dose: Steady State MaximalArea Under the Plasma Concentration Versus Time Curve Within One Dose Interval (CssAUCt,maxss) in the Dose Escalation and Dose Finding portionTime frame: Cycle 1 (each cycle is 28 days) and Day 1 of each subsequent cycle and at study completion visit, up to approximately 24 months → Cycle 1 (each cycle is 28 days) for Parts 1A/1B/1C/1E/1F; Cycle 2 (each cycle is 28 days) for Part 1G
  • EditedSteady State Area Under the Plasma Concentration Versus Time Curve Within One Dose Interval (AUCssAUCt,tss) in the Dose Escalationof Tamoxifen, 4-hydroxy-tamoxifen, N-desmethyltamoxifen, and Dose Finding portionEndoxifenTime frame: Cycle 1 (each cycle is 28 days) and Day 1 of each subsequent cycle and at study completion visit, up to approximately 24 months → Cycle 2 (each cycle is 28 days)
  • EditedSteady State Peak and Trough Concentration of PF-07220060Time frame: Cycle 1 (each cycle is 28 days) and Day 1 of each subsequent cycle and at study completion visit, up to approximately 24 months → Cycle 1 (each cycle is 28 days) for Part 2A/2B/2C/2E; Cycle 2 (each cycle is 28 days) for Part 2F
  • EditedSteady State Peak and trough concentrationsConcentration of enzalutamideEnzalutamide and N-desmethyl enzalutamideEnzalutamideTime frame: Cycle 1 (each cycle is 28 days) and Day 1 of each subsequent cycle and at study completion visit, up to approximately 24 months → Cycles 1 - 12 (each cycle is 28 days)
  • AddedSteady State Trough Concentration of Enzalutamide and N-desmethyl EnzalutamideTime frame: Cycle 3 (each cycle is 28 days)
  • AddedIncidence of clinically significant AEsTime frame: Cycle 1 (each cycle is 28 days) through study completion, up to approximately 24 months
  • AddedIncidence of clinically significant laboratory assessmentsTime frame: Cycle 1 (each cycle is 28 days) through study completion, up to approximately 24 months
  • AddedSteady State Minimal Concentration (Cmin,ss) of Tamoxifen, 4-hydroxy-tamoxifen, N-desmethyltamoxifen, and EndoxifenTime frame: Cycle 2 (each cycle is 28 days)
  • AddedMetabolite to Parent Ratio of Minimal Concentration (MRCmin) of 4-hydroxy-tamoxifen, N-desmethyltamoxifen, and EndoxifenTime frame: Cycle 2 (each cycle is 28 days)
  • AddedSteady State Trough Concentration of PF-07220060Time frame: Cycle 1 (each cycle is 28 days) for Parts 2A/2B/2C/2E; Cycle 2 (each cycle is 28 days) for Part 2F
  • RemovedMultiple Dose: Time to Maximum Plasma Concentration at Steady State (Tss,max) in the Dose Escalation and Dose Finding portionTime frame: Cycle 1 (each cycle is 28 days) and Day 1 of each subsequent cycle and at study completion visit, up to approximately 24 months
  • RemovedMultiple Dose: Steady State Minimum Plasma Concentration (Css,min) in the Dose Escalation and Dose Finding portionTime frame: Cycle 1 (each cycle is 28 days) and Day 1 of each subsequent cycle and at study completion visit, up to approximately 24 months
  • RemovedMultiple Dose: Steady State Apparent Oral Plasma Clearance (CLss/F) in the Dose Escalation and Dose Finding portionTime frame: Cycle 1 (each cycle is 28 days) and Day 1 of each subsequent cycle and at study completion visit, up to approximately 24 months
  • RemovedMultiple Dose: Apparent Volume of Distribution at Steady State (Vss/F) in the Dose Escalation and Dose Finding portionTime frame: Cycle 1 (each cycle is 28 days) and Day 1 of each subsequent cycle and at study completion visit, up to approximately 24 months
  • RemovedMultiple Dose: Terminal Elimination Half-Life (t1/2) in the Dose Escalation and Dose Finding portionTime frame: Cycle 1 (each cycle is 28 days) and Day 1 of each subsequent cycle and at study completion visit, up to approximately 24 months
  • RemovedMultiple Dose: Accumulation Ratio (Rac (AUCss,t /AUCsd,t)) in the Dose Escalation and Dose Finding portionTime frame: Cycle 1 (each cycle is 28 days) and Day 1 of each subsequent cycle and at study completion visit, up to approximately 24 months
  • RemovedTime to Progression (TTP)Time frame: baseline up to approximately 24 months
  • RemovedTime to first skeletal eventsTime frame: Cycle 1 (each cycle is 28 days) to up to approximately 24 months
  • RemovedQuality of life questionnaireTime frame: Cycle 1 (each cycle is 28 days) to up to approximately 24 months
  • RemovedRadiographic Progression Free survivalTime frame: Cycle 1 (each cycle is 28 days) up to approximately 24 months
  • Time frameSingle Dose: Time to Maximum Plasma Concentration (Tmax) in the Dose Escalation and Dose Finding portionCycle 1 (each cycle is 28 days) and Day 1 of each subsequent cycle and at study completion visit, up to approximately 24 months → Cycle 1 (each cycle is 28 days)
  • Time frameSingle Dose: Area Under the Plasma Concentration Versus Time Curve from Time Zero to the Last Sampling Time Point Within the Dose Interval (AUClast) in the Dose Escalation and Dose Finding portionCycle 1 (each cycle is 28 days) and Day 1 of each subsequent cycle and at study completion visit, up to approximately 24 months → Cycle 1 (each cycle is 28 days)
  • Time framePSA50Cycle 1 (each cycle is 28 days) to up to approximately 24 months → Cycle 1 (each cycle is 28 days) through study completion, up to approximately 24 months
  • DescriptionClinical Benefit Rate (CBR): how it is measured was reworded
  • DescriptionPSA50: how it is measured was reworded
  • DescriptionSingle Dose: Area Under the Plasma Concentration Versus Time Curve from Time Zero to the Last Sampling Time Point Within the Dose Interval (AUClast) in the Dose Escalation and Dose Finding portion: how it is measured was reworded
  • …and 2 more, on the record history on ClinicalTrials.gov ↗
Oct 21, 2026
Contact
Study contact now listed: added C•••@pfizer.com · •••1021. See the current contact
Oct 21, 2026
Design
Phase changed
across 2 updates, Oct 21, 2026 – Nov 10, 2026
Show all 3 updates
  1. Nov 10, 2026
    Publications 1 publication citing this study linked from PubMed, e.g. PubMed 41943159 ↗
    Ellison Institute is now Recruiting
    Design Removed Phase 1
    + 2 other changes: verification date and description
  2. Oct 28, 2026
    Minor edits only
    + 1 other change: description
  3. Oct 21, 2026
    Active, not recruiting→Recruiting
    39 sites changed recruiting status (29 now active, not recruiting, 10 now recruiting)
    Show 39 sites
    • Ellison Institute · Los Angeles, United Statesno status→Active, not recruiting
    • Smilow Cancer Hospital - Yale New Haven Health · New Haven, United Statesno status→Recruiting
    • Yale-New Haven Hospital-Yale Cancer Center · New Haven, United Statesno status→Recruiting
    • Smilow Cancer Hospital Phase 1 Unit · New Haven, United Statesno status→Recruiting
    • Yale University - Smilow Cancer Hospital; C/O Thomas Ferencz, RPh, BCOP · New Haven, United Statesno status→Recruiting
    • Smilow Cancer Hospital - Trumbull · Trumbull, United Statesno status→Recruiting
    • Brigham & Women's Hospital · Boston, United Statesno status→Active, not recruiting
    • Dana-Farber Cancer Institute · Boston, United Statesno status→Active, not recruiting
    • Dana Farber Cancer Institute- Chestnut Hill · Newton, United Statesno status→Active, not recruiting
    • START Midwest · Grand Rapids, United Statesno status→Recruiting
    • Sarah Cannon Research Institute - Pharmacy · Nashville, United Statesno status→Recruiting
    • SCRI Oncology Partners · Nashville, United Statesno status→Recruiting
    • The University of Texas MD Anderson Cancer Center · Houston, United Statesno status→Recruiting
    • The University of Texas, MD Anderson Cancer Center - West Houston · Houston, United Statesno status→Recruiting
    • Hospital Británico de Buenos Aires · Ciudad Autónoma de Buenos Aires, Argentinano status→Active, not recruiting
    • Fundación Cenit Para La Investigación En Neurociencias · CABA, Argentinano status→Active, not recruiting
    • Fundación Respirar · Buenos Aires, Argentinano status→Active, not recruiting
    • Clínica Universitaria Reina Fabiola · Córdoba, Argentinano status→Active, not recruiting
    • Fundación CORI para la Investigación y Prevención del Cáncer · La Rioja, Argentinano status→Active, not recruiting
    • Cancer Hospital Chinese Academy of Medical Science · Beijing, Chinano status→Active, not recruiting
    • Henan Cancer Hospital · Zhengzhou, Chinano status→Active, not recruiting
    • Hubei Cancer Hospital · Wuhan, Chinano status→Active, not recruiting
    • The First Affiliated Hospital of Xi'an Jiaotong University · Xi’an, Chinano status→Active, not recruiting
    • Sir Run Run Shaw Hospital, Zhejiang University School of Medicine · Hangzhou, Chinano status→Active, not recruiting
    • Vseobecna fakultni nemocnice v Praze · Prague, Czechiano status→Active, not recruiting
    • National Cancer Center Hospital East · Kashiwa, Japanno status→Active, not recruiting
    • COI Centro Oncologico Internacional S.A.P.I. de C.V. · Mexico City, Mexicono status→Active, not recruiting
    • Hospital MAC Periferico Sur · Mexico City, Mexicono status→Active, not recruiting
    • INCAN · Mexico City, Mexicono status→Active, not recruiting
    • Hospital Universitario "Dr. Jose Eleuterio Gonzalez" · Monterrey, Mexicono status→Active, not recruiting
    • …and 9 more on the registry record
    Primary completion Sep 23, 2026→Oct 7, 2029
    Study completion Nov 23, 2027→Oct 7, 2029
    Enrollment 362 (actual)→430 (estimated)
    Eligibility 5 inclusion criteria edited, 4 added, 9 removed; 1 exclusion criterion edited, 2 added, 1 removed
    What changed in the criteria
    Inclusion criteria
    • EditedPart 1A/Part 1D/Part1EPart 1E also include: Refractory HR-positive/HER2-positive BC
    • EditedPart 1G: HR-positive/HER2-negative BC
    • RemovedPatients who are either postmenopausal women or pre/peri-menopausal (Part 2C only)
    • EditedPart 2A, 2B, 2C, 2E, and 2E2F: HR-positive/HER2-negative BC
    • RemovedLesion:
    • RemovedPart 1: evaluable lesion (including skin or bone lesion only)
    • RemovedPart 2A, 2B, 2C and 2E: measurable lesion per RECIST v1.1
    • RemovedPart 2D: Participants with evaluable disease as per PCWG3; participants with bone metastases only are allowed. Participants with biochemical recurrence only are excluded.
    • AddedGiredestrant Combination Cohort: ER-positive/HER2-negative BC
    • RemovedAt least 1 line of anti-endocrine in countries without CDK4/6 inhibitor approval or reimbursement, for advanced or metastatic disease
    • EditedPart 2A and 2E: participants must have received at least 1 line of standard of care (including prior CDK4/6i) for advanced/metastatic disease; Prior chemo is allowed; Prior fulvestrant, mTOR and/or PI3K inhibitors are allowed
    • EditedPart 2B: participants who have not received anyno prior systemic anti-cancer therapies for advanced/metastatic BC
    • RemovedPart 2D:
    • RemovedReceived prior abiraterone; enzalutamide and CDK4i naive
    • Removed0-1 line of chemotherapy is allowed General Inclusion Criteria
    • AddedPart 1G and 2F: at least 2 lines of SOC for advanced or metastatic disease, including CDK4/6 inhibitor and endocrine therapy
    • AddedGiredestrant Combination Cohort: at least 1 (no more than 3) prior line(s) of SOC for advanced or metastatic disease, including CDK4/6 inhibitor and endocrine therapy
    • AddedGeneral Inclusion Criteria
    Exclusion criteria
    • RemovedPart 1D: participants who have had a gastrectomy or have dietary or other restrictions that preclude a 10 hour overnight fast or consumption of the high fat, high calorie meal
    • EditedLast anti-cancer treatment within 2 weeks prior to study intervention; Part 1G and 2F: tamoxifen treatment within 35 days of Day -4
    • AddedPart 1G and 2F: history of or current pulmonary embolism or deep vein thrombosis
    • AddedGiredestrant Combination Cohort: history (within 6 months of screening) of or presence of idiopathic symptomatic bradycardia or resting heart rate <50 bpm at screening
    Primary outcomes 1 edited, 3 time frame changed, 14 added, 2 removed
    What changed in the outcomes
    • EditedNumber of participants with dose limiting toxicities in the Dose Escalation or De-escalation PortionTime frame: Baseline up to day 28 of Cycle 1. → At the end of Cycle 1 (each cycle is 28 days)
    • AddedMaximal Plasma Concentration (Cmax) of PF-07220060 given with and without foodTime frame: Cycle 1 (each cycle is 28 days)
    • AddedTime to Maximum Plasma Concentration (Tmax) of PF-07220060 given with and without foodTime frame: Cycle 1 (each cycle is 28 days)
    • AddedArea Under the Plasma Concentration Versus Time Curve from Time Zero to the Last Sampling Time Point (AUClast) of PF-07220060 given with and without foodTime frame: Cycle 1 (each cycle is 28 days)
    • AddedMaximal Plasma Concentration (Cmax) of Midazolam with and without PF-07220060Time frame: Cycle 1 (each cycle is 28 days)
    • AddedTime to Maximum Plasma Concentration (Tmax) of Midazolam with and without PF-07220060Time frame: Cycle 1 (each cycle is 28 days)
    • AddedArea Under the Plasma Concentration Versus Time Curve from Time Zero to the Last Sampling Timepoint (AUClast) of Midazolam with and without PF-07220060Time frame: Cycle 1 (each cycle is 28 days)
    • AddedSteady State Maximal Concentration (Cmax,ss) of PF-07220060Time frame: Cycle 1 (each cycle is 28 days)
    • AddedSteady State Time to Maximum Plasma Concentration (Tmax,ss) of PF-07220060Time frame: Cycle 1 (each cycle is 28 days)
    • AddedSteady State Area Under the Plasma Concentration Versus Time Curve Within One Dose Interval (AUCτ,ss) of PF-07220060Time frame: Cycle 1 (each cycle is 28 days)
    • AddedSteady State Minimum Plasma Concentration (Cmin,ss) of PF-07220060Time frame: Cycle 1 (each cycle is 28 days)
    • AddedSteady State Maximal Concentration (Cmax,ss) of GiredestrantTime frame: Cycle 1 (each cycle is 28 days)
    • AddedSteady State Time to Maximum Plasma Concentration (Tmax,ss) of GiredestrantTime frame: Cycle 1 (each cycle is 28 days)
    • AddedSteady State Area Under the Plasma Concentration Versus Time Curve Within One Dose Interval (AUCτ,ss) of GiredestrantTime frame: Cycle 1 (each cycle is 28 days)
    • AddedSteady State Minimum Plasma Concentration (Cmin,ss) of GiredestrantTime frame: Cycle 1 (each cycle is 28 days)
    • RemovedFood EffectTime frame: Day -7 through the end of Cycle 1
    • RemovedDDITime frame: D1 to the end of Cycle 1
    • Time frameIncidence of clinically significant AEsWeekly during Cycle 1 and 2 and then every 28 days through study completion, up to approximately 24 months; Each cycle is 28 days → Cycle 1 (each cycle is 28 days) through study completion, up to approximately 24 months
    • Time frameIncidence of clinically significant laboratory assessmentsWeekly during Cycle 1 and 2 (each cycle is 28 days) and then every 28 days through study completion, up to approximately 24 months → Cycle 1 (each cycle is 28 days) through study completion, up to approximately 24 months
    • Time frameIncidence of clinically significant abnormal vital and ECG parametersDay 1, Day 8, Day 15 of Cycle 1 and starting from Cycle 2, and then every 28 days through study completion, up to approximately 24 months (Each cycle is 28 days) → Cycle 1 (each cycle is 28 days) through study completion, up to approximately 24 months
    Secondary outcomes 8 edited, 3 time frame changed, 6 added, 10 removed, 3 description edited, 2 more
    What changed in the outcomes
    • EditedSingle Dose: Maximal concentrationPlasma Concentration (Cmax) in the Dose Escalation and Dose Finding portionTime frame: Cycle 1 (each cycle is 28 days) and Day 1 of each subsequent cycle and at study completion visit, up to approximately 24 months → Cycle 1 (each cycle is 28 days)
    • EditedSingleMultiple Dose: Area Under the PlasmaSteady State Maximal Concentration Versus Time Curve from Time Zero Extrapolated to Infinity (AUCinfCmax,ss) in the Dose Escalation and Dose Finding portionTime frame: Time Frame: Cycle 1 (each cycle is 28 days) and Day 1 of each subsequent cycle and at study completion visit, up to approximately 24 months → Cycle 1 (each cycle is 28 days) for Parts 1A/1B/1C/1E/1F; Cycle 2 (each cycle is 28 days) for Part 1G
    • EditedApparent OralMultiple Dose: Steady State Time to Maximum Plasma ClearanceConcentration (CL/FTmax,ss) in the Dose Escalation and Dose Finding portionTime frame: Cycle 1 (each cycle is 28 days) and Day 1 of each subsequent cycle and at study completion visit, up to approximately 24 months → Cycle 1 (each cycle is 28 days) for Parts 1A/1B/1C/1E/1F; Cycle 2 (each cycle is 28 days) for Part 1G
    • EditedSingleMultiple Dose: Apparent Volume of DistributionSteady State Minimum Plasma Concentration (Vz/FCmin,ss) in the Dose Escalation and Dose Finding portionTime frame: Cycle 1 (each cycle is 28 days) and Day 1 of each subsequent cycle and at study completion visit, up to approximately 24 months → Cycle 1 (each cycle is 28 days) for Parts 1A/1B/1C/1E/1F; Cycle 2 (each cycle is 28 days) for Part 1G
    • EditedMultiple Dose: Steady State MaximalArea Under the Plasma Concentration Versus Time Curve Within One Dose Interval (CssAUCt,maxss) in the Dose Escalation and Dose Finding portionTime frame: Cycle 1 (each cycle is 28 days) and Day 1 of each subsequent cycle and at study completion visit, up to approximately 24 months → Cycle 1 (each cycle is 28 days) for Parts 1A/1B/1C/1E/1F; Cycle 2 (each cycle is 28 days) for Part 1G
    • EditedSteady State Area Under the Plasma Concentration Versus Time Curve Within One Dose Interval (AUCssAUCt,tss) in the Dose Escalationof Tamoxifen, 4-hydroxy-tamoxifen, N-desmethyltamoxifen, and Dose Finding portionEndoxifenTime frame: Cycle 1 (each cycle is 28 days) and Day 1 of each subsequent cycle and at study completion visit, up to approximately 24 months → Cycle 2 (each cycle is 28 days)
    • EditedSteady State Peak and Trough Concentration of PF-07220060Time frame: Cycle 1 (each cycle is 28 days) and Day 1 of each subsequent cycle and at study completion visit, up to approximately 24 months → Cycle 1 (each cycle is 28 days) for Part 2A/2B/2C/2E; Cycle 2 (each cycle is 28 days) for Part 2F
    • EditedSteady State Peak and trough concentrationsConcentration of enzalutamideEnzalutamide and N-desmethyl enzalutamideEnzalutamideTime frame: Cycle 1 (each cycle is 28 days) and Day 1 of each subsequent cycle and at study completion visit, up to approximately 24 months → Cycles 1 - 12 (each cycle is 28 days)
    • AddedSteady State Trough Concentration of Enzalutamide and N-desmethyl EnzalutamideTime frame: Cycle 3 (each cycle is 28 days)
    • AddedIncidence of clinically significant AEsTime frame: Cycle 1 (each cycle is 28 days) through study completion, up to approximately 24 months
    • AddedIncidence of clinically significant laboratory assessmentsTime frame: Cycle 1 (each cycle is 28 days) through study completion, up to approximately 24 months
    • AddedSteady State Minimal Concentration (Cmin,ss) of Tamoxifen, 4-hydroxy-tamoxifen, N-desmethyltamoxifen, and EndoxifenTime frame: Cycle 2 (each cycle is 28 days)
    • AddedMetabolite to Parent Ratio of Minimal Concentration (MRCmin) of 4-hydroxy-tamoxifen, N-desmethyltamoxifen, and EndoxifenTime frame: Cycle 2 (each cycle is 28 days)
    • AddedSteady State Trough Concentration of PF-07220060Time frame: Cycle 1 (each cycle is 28 days) for Parts 2A/2B/2C/2E; Cycle 2 (each cycle is 28 days) for Part 2F
    • RemovedMultiple Dose: Time to Maximum Plasma Concentration at Steady State (Tss,max) in the Dose Escalation and Dose Finding portionTime frame: Cycle 1 (each cycle is 28 days) and Day 1 of each subsequent cycle and at study completion visit, up to approximately 24 months
    • RemovedMultiple Dose: Steady State Minimum Plasma Concentration (Css,min) in the Dose Escalation and Dose Finding portionTime frame: Cycle 1 (each cycle is 28 days) and Day 1 of each subsequent cycle and at study completion visit, up to approximately 24 months
    • RemovedMultiple Dose: Steady State Apparent Oral Plasma Clearance (CLss/F) in the Dose Escalation and Dose Finding portionTime frame: Cycle 1 (each cycle is 28 days) and Day 1 of each subsequent cycle and at study completion visit, up to approximately 24 months
    • RemovedMultiple Dose: Apparent Volume of Distribution at Steady State (Vss/F) in the Dose Escalation and Dose Finding portionTime frame: Cycle 1 (each cycle is 28 days) and Day 1 of each subsequent cycle and at study completion visit, up to approximately 24 months
    • RemovedMultiple Dose: Terminal Elimination Half-Life (t1/2) in the Dose Escalation and Dose Finding portionTime frame: Cycle 1 (each cycle is 28 days) and Day 1 of each subsequent cycle and at study completion visit, up to approximately 24 months
    • RemovedMultiple Dose: Accumulation Ratio (Rac (AUCss,t /AUCsd,t)) in the Dose Escalation and Dose Finding portionTime frame: Cycle 1 (each cycle is 28 days) and Day 1 of each subsequent cycle and at study completion visit, up to approximately 24 months
    • RemovedTime to Progression (TTP)Time frame: baseline up to approximately 24 months
    • RemovedTime to first skeletal eventsTime frame: Cycle 1 (each cycle is 28 days) to up to approximately 24 months
    • RemovedQuality of life questionnaireTime frame: Cycle 1 (each cycle is 28 days) to up to approximately 24 months
    • RemovedRadiographic Progression Free survivalTime frame: Cycle 1 (each cycle is 28 days) up to approximately 24 months
    • Time frameSingle Dose: Time to Maximum Plasma Concentration (Tmax) in the Dose Escalation and Dose Finding portionCycle 1 (each cycle is 28 days) and Day 1 of each subsequent cycle and at study completion visit, up to approximately 24 months → Cycle 1 (each cycle is 28 days)
    • Time frameSingle Dose: Area Under the Plasma Concentration Versus Time Curve from Time Zero to the Last Sampling Time Point Within the Dose Interval (AUClast) in the Dose Escalation and Dose Finding portionCycle 1 (each cycle is 28 days) and Day 1 of each subsequent cycle and at study completion visit, up to approximately 24 months → Cycle 1 (each cycle is 28 days)
    • Time framePSA50Cycle 1 (each cycle is 28 days) to up to approximately 24 months → Cycle 1 (each cycle is 28 days) through study completion, up to approximately 24 months
    • DescriptionClinical Benefit Rate (CBR): how it is measured was reworded
    • DescriptionPSA50: how it is measured was reworded
    • DescriptionSingle Dose: Area Under the Plasma Concentration Versus Time Curve from Time Zero to the Last Sampling Time Point Within the Dose Interval (AUClast) in the Dose Escalation and Dose Finding portion: how it is measured was reworded
    • …and 2 more, on the record history on ClinicalTrials.gov ↗
    Interventions Added Midazolam·Combination product: Giredestrant·Combination product: Tamoxifen; removed Drug: Midazolam. Arm changed 2D Combination Dose Expansion→2F Combination Dose Expansion. Arms added: 1G Combination Dose Finding Arm 1·Giredestrant Combination Cohort (Group A)·Giredestrant Combination Cohort (Group B)
    Design Added Phase 1
    Contact Study contact now listed: added C•••@pfizer.com · •••1021. See the current contact
    + 4 other changes: verification date, description, conditions and index terms

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT04557449
Lead sponsor
Pfizer
Responsible party
Sponsor
First posted
Sep 21, 2020
Start date
Sep 23, 2020
Primary completion
Oct 7, 2029 (estimated)
Completion
Oct 7, 2029 (estimated)
Last update
Nov 10, 2026

Study contacts

Pfizer CT.gov Call Center
Contact
ClinicalTrials.gov_Inquiries@pfizer.com
1-800-718-1021
Pfizer CT.gov Call Center
study director · Pfizer

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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