CompletedNCT03054363Updated Nov 13, 2023Results posted

Tucatinib, Palbociclib and Letrozole in Metastatic Hormone Receptor Positive and HER2-positive Breast Cancer

A Phase 1/2 interventional study of Tucatinib in Combination with Palbociclib and Letrozole and Tucatinib in Combination with Palbociclib and Letrozole in Breast Cancer, sponsored by University of Colorado, Denver. Completed at 6 sites in United States. Open to female participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2023-11-13.

Sponsored by University of Colorado, Denver · Phase 1/2, Interventional, and Treatment

Phase: Phase 1/2
Study type: Interventional
Enrollment: 42
Allocation: Randomized
Ages: 18 Years to 100 Years
Sex: Female

Study summary

This is a multicenter run-in phase Ib / roll-over phase II study of triple targeted drug combination (HER2-targeted small molecule inhibitor tucatinib, CDK4/6 inhibitor palbociclib and aromatase inhibitor letrozole) as a first or second line of therapy in patients with metastatic hormone receptor positive and HER2-positive breast cancer.

Read the detailed description

This is a multicenter, single arm, open-label, run-in phase Ib / roll-over phase II study of novel HER2-targeted tyrosine kinase inhibitor tucatinib in combination with CDK4/6 inhibitor palbociclib and aromatase inhibitor letrozole in subjects with HR+/HER2+ locally advanced unresectable or metastatic breast cancer. The study will enroll post-menopausal women and premenopausal women if on treatment with or willing to be treated with standard ovarian suppression. The phase Ib part of the study will determine safety and tolerability of the combination of tucatinib, palbociclib and letrozole to confirm that current RP2D of tucatinib and FDA approved dosing of palbociclib remains the same in the triplet combination. The dose of letrozole will be constant through the study period. Once the safety of the combination is established, we will move to the phase II part of the study in the expansion cohort of subjects at RP2D for the purpose of assessing efficacy while further refining assessment of safety of the combination treatment.

Conditions studied

Breast Cancer

Browse trials for

Breast Neoplasms 12,544

Keywords

Metastatic Breast Cancer
Tucatinib
Palbociclib
Letrozole
HR-positive
HER2-positive
ER-positive
PR-positive
HER2-targeted therapy
CDK4/6 inhibitor
ONT-380
Ibrance

In context

Breast Neoplasms

12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.

This study's enrollment of 42 is below the median of 72 across 9,303 interventional studies indexed under Breast Neoplasms.

Browse Breast Neoplasms studies →

Lead sponsor

University of Colorado, Denver is the lead sponsor of 1,499 studies on the registry; 315 are open to participants now.

Of its 139 completed or terminated interventional studies of FDA-regulated products, 89 (64%) have results posted.

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

Who can participate

Ages eligible: 18 Years to 100 Years
Sexes eligible: Female
Accepts healthy volunteers: No

Inclusion criteria

Subjects must have a histologically confirmed diagnosis of HR+/HER2+ locally advanced unresectable or metastatic breast cancer. Estrogen or progesterone receptor positivity is defined by IHC according to the most recent ASCO/CAP guidelines. HER2 positivity is defined by standard of care fluorescence in situ hybridization (FISH) and/or 3+ staining by IHC according to the most recent ASCO/CAP guidelines.
Measurable and/or evaluable disease per RECIST 1.1 criteria and/or RANO-BM criteria
. Bone only disease is allowed.
CNS inclusion criteria:
- Subjects without CNS metastases are eligible. Note: brain imaging is not required for asymptomatic subjects without known brain metastatic disease prior to enrollment into the study
- Subjects with untreated asymptomatic CNS metastases not needing immediate local therapy in the opinion of investigator are eligible. For subjects with untreated asymptomatic CNS lesions > 2.0 cm by contrast-enhanced MRI, discussion with and approval from the Lead PI is required prior to enrollment
- Subjects with stable brain metastases previously treated with radiation therapy or surgery are allowed to enroll, provided that they are off corticosteroids or on stable/tapering dose of corticosteroids and stability of CNS metastatic disease for at least 4 weeks has been demonstrated, with the last MRI taken within 2 weeks prior to cycle 1 day 1 of the study.
Relevant records of any CNS treatment must be available to allow for classification of target and non-target lesions
Age ≥ 18 years
ECOG performance status 0-1
Life expectancy of more than 6 months, in the opinion of the investigator
Study subjects should be post-menopausal women; premenopausal women are eligible if on ovarian suppression, or agreeable to mandatory ovarian suppression. Women of childbearing potential, defined as premenopausal women who are not permanently sterile (i.e., due to hysterectomy, bilateral oophorectomy, bilateral tubal ligation, or bilateral tubal occlusion) are required to have negative pregnancy tests prior to initiation of treatment.
Prior treatments:
- Subjects should have received at least two approved HER2-targeted agents (trastuzumab, pertuzumab, or TDM-1) in the course of their disease
- Subjects should have had at least 1 line of prior HER2-targeted therapy in the metastatic setting, with the exception of asymptomatic subjects with oligometastatic or bone / soft tissue only disease who, on investigator opinion, are appropriate for a single agent antiendocrine therapy per NCCN guidelines
- Subjects who have had up to 2 lines of prior endocrine therapy in the metastatic setting are allowed. Prior adjuvant and/or neoadjuvant endocrine regimens are allowed and not counted towards this limit
Adequate organ and marrow function as defined below:
- Absolute neutrophil count ≥ 1,500/mm3
- Platelets ≥ 75,000/mm3
- Hemoglobin ≥ 9.0 mg/dL without red blood cell transfusion ≤ 7 days prior to Cycle 1Day 1 of therapy
- Total serum bilirubin ≤ 1.5 X upper limit of normal (ULN) except for subjects with known Gilbert's disease, who may enroll if the conjugated bilirubin is ≤ 1.5 ULN
- AST (SGOT)/ALT (SGPT) ≤2.5 X ULN;
- Serum creatinine ≤ 1.5 mg/dL
- International normalized ratio (INR) and activated partial thromboplastin time (aPTT) ≤1.5 X ULN unless on medication known to alter INR and aPTT
- Left ventricular ejection fraction (LVEF) ≥ 50% (as assessed by ECHO or MUGA) documented within 4 weeks prior to first dose of study treatment
- Serum or urine pregnancy test (for women of childbearing potential) negative ≤ 7 days of starting treatment
Ability to understand and the willingness to sign a written informed consent and comply with the study scheduled visits, treatment plans, laboratory tests and other procedures.
Subject or legally authorized representative of a subject must provide signed informed consent per a consent document that has been approved by an institutional review board or independent ethics committee (IRB/IEC) prior to initiation of any study-related tests or procedures that are not part of standard-of-care for the subject's disease.

Exclusion criteria

Exclusion criteria:

Subjects with previously treated progressing brain metastases are excluded from the study
Subjects with known brain metastases and contraindications to undergo contrast MRI imaging of the brain are excluded from the study
Pregnancy or breast feeding
Current active treatment with an investigational agent
Known history of hypersensitivity to aromatase-inhibitor drugs
Any toxicity related to prior cancer therapies that has not resolved to ≤ Grade 1, with the exception of peripheral neuropathy, which must have resolved to ≤ Grade 2, and alopecia
Previous treatment with lapatinib, neratinib, afatinib, or other investigational EGFR-family receptor tyrosine kinase inhibitor or HER2 tyrosine kinase inhibitor
Previous treatment with palbociclib, abemaciclib, ribociclib or other investigational CDK4/6 inhibitors
Any systemic anti-cancer therapy (including hormonal therapy), radiation, or experimental agent ≤ 2 weeks of first dose of study treatment
Active bacterial, fungal or viral infections requiring treatment with IV antibiotic, IV antifungal, or IV anti-viral drugs
Known hepatitis B (HBV), hepatitis C (HCV) or human immunodeficiency virus (HIV) infections. Note: pretesting is not required.
Inability to swallow pills or any significant gastrointestinal disease which would preclude the adequate oral absorption of medications
Use of prohibited medications within 3 elimination half-lives prior to first dose of the study treatment
Known myocardial infarction, severe/unstable angina, percutaneous transluminal coronary angioplasty/stenting (PTCA), or coronary artery bypass graft (CABG) within 6 month of the first dose of the study treatment
Clinically significant cardio-vascular disease, such as ventricular arrhythmia requiring therapy, uncontrolled hypertension (defined as persistent systolic blood pressure > 160 mm Hg and/or diastolic blood pressure > 100 mm Hg on antihypertensive medications), or any history of symptomatic congestive heart failure (CHF)
Other severe acute or chronic medical or psychiatric conditions or laboratory abnormalities that may increase the risk associated with study participation or study drug administration, or may interfere with the interpretation of study results, or in the judgment of the investigator would make the subject inappropriate for entry into the study.

Study design

Phase: Phase 1 / Phase 2
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Single group
Masking: None (open label)
Enrollment: 42 participants (actual)

Study arms

Experimental
Phase 1b
Tucatinib 300 mg PO BID, palbociclib 125 mg PO daily 21 days on and 7 days off, and letrozole 2.5 mg PO daily on a 28 day cycle length.
Drug: Tucatinib in Combination with Palbociclib and Letrozole
Experimental
Phase II
Tucatinib 300 mg BID; palbociclib 75 mg PO daily 21 days on, 7 days off; letrozole 2.5 mg PO daily.
Drug: Tucatinib in Combination with Palbociclib and Letrozole

Interventions

DrugTucatinib in Combination with Palbociclib and Letrozole
Starting dose of combination therapy : Tucatinib 300 mg PO BID Palbociclib 125 mg PO daily 21 day on, 7 days off Letrozole 2.5 mg PO daily
Also known as: ONT-380, IBRANCE, Femara
DrugTucatinib in Combination with Palbociclib and Letrozole
Subjects Tucatinib 300 mg PO BID Palbociclib 75mg PO daily 21 days on followed by 7 days off Letrozole 2.5 mg PO daily.
Also known as: ONT-380, IBRANCE, Femara

What researchers measure

Primary outcomes

Phase Ib Primary Outcome: Proportion of Patients Who Experienced DLTs Attributable to Palbociclib, Tucatinib, or Both
To measure safety and tolerability of tucatinib used in combination with palbociclib and letrozole, we will assess the proportion of subjects experiencing dose-limiting toxicities (DLTs) potentially attributable to tucatinib, palbociclib, or both drugs, and compare them to predefined safety thresholds. DLT was defined as any grade ≥ 3 nonhematologic adverse event, grade 3 neutropenia with fever, grade 3 thrombocytopenia with bleeding, or any hematologic toxicity grade ≥ 4 using NCI CTCAE version 4.03. Safety was considered clinically meaningfully altered if ≥60% of subjects experienced DLTs secondary palbociclib, ≥20% of subjects had toxicity secondary to tucatinib, or ≥50% of subjects had DLTs attributable to both drugs. If the proportion of patients with DLTs cross safety boundaries, doses of tucatinib, palbociclib or both medications would be decreased. Letrozole dose was kept constant for all study subjects.
Time frame: 15 months (From date of first consent until final safety analysis of Phase Ib)
Phase II Primary Outcome: Median Progression-free Survival (mPFS)
To measure efficacy of tucatinib used in combination with palbociclib and letrozole, the median PFS (primary objective of Phase II) will be assessed. mPFS is defined as the time from allocation to the first documented disease progression according to RECIST 1.1, or death due to any cause, whichever occurs first. For subjects with brain metastatic disease enrolled in the study, assessment of bi-compartmental mPFS in the non-CNS and CNS compartments, defined as the time from allocation to the first documented disease progression according to RECIST 1.1 and/or RANO-BM criteria, or death due to any cause, whichever occurs first. For patient with CNS metastases who had an event of isolated CNS progression, underwent local therapy, and remained on study per protocol, mPFS was calculated as the time from the start of treatment until the first CNS progression.
Time frame: 4 years (data cutoff of PFS calculation was when PFS became mature according to study statistician)

Secondary outcomes

Phase Ib Secondary Outcome: Tucatinib and Palbociclib AUC[0-6] Post Tucatinib and Palbociclib Dose
Pharmacokinetic (PK) assessments of blood levels of tucatinib and palbociclib will be performed on Cycle 1 Day 15 and Cycle 2 Day 1 of therapy in 20 participants enrolled in the phase Ib part of the study. Plasma samples will be collected to measure levels of tucatinib and its hydroxyl metabolite ONT-993, as well as levels of palbociclib and, if needed, its metabolites at steady state on Cycle 1 Day 15. The area under the curve (AUC) of the concentration vs. time plot is computed from 0 to 6 hours after the tucatinib and palbociclib dose.
Time frame: 0, 0.5, 1, 2, 3, 4, and 6 hours post-dose
Phase II Secondary Outcome: Palbociclib AUC[10-19] Post Tucatinib and Palbociclib Dose
Additional pharmacokinetic (PK) assessment will be done in 5 to 10 patients enrolled in phase II part of the study to evaluate the levels of tucatinib and palbociclib. These PKs will be done on Cycle 1 Day 9 and Cycle 2 Day 9. Prior to the first set of PKs, on Cycle 1 Days 1-8, patient will take palbociclib and letrozole; tucatinib will be on hold. Tucatinib will be started per usual study schedule after the first set of PKs is obtained on Day 9. Prior to the second set of PKs, on Cycle 2 Days 1-8, patient will take palbociclib, letrozole and tucatinib (all study drugs) per usual study schedule. On the day prior to PK evaluation (Day 8 of Cycle 1 and Day 8 of Cycle 2), patient should consume high calorie / high fat meal and take study drugs. On the next day, plasma samples will be collected to measure PKs at 10, 13, 16 and 19 hrs +/- 10 minutes post dose.
Time frame: 10, 13, 16, and 19 hours post-dose
Phase II Secondary Outcome: Clinical Benefit Rate (CBR)
Clinical benefit rate (CBR) was assessed in patients with measurable lesions and defined as the proportion of patients with complete response, partial response, or stable disease for 6 months or more. It is one of the parameters used to assess tumor response in this study and was evaluated using RECIST 1.1 (and/or RANO-BM for patients with CNS disease).
Time frame: 4 years
Phase II Secondary Outcome: Overall Response Rate (ORR)
Overall response rate (ORR) is defined as the proportion of subjects who had complete or partial response by RECIST 1.1 (and/or RANO-BM for patients with CNS disease).
Time frame: 4 years
Phase II Secondary Outcome: Median Duration of Response (mDOR)
Median duration of response (mDOR) is defined as the time from enrollment in the clinical trial until objective tumor progression or death, whichever occurs first.
Time frame: 4 years

Results

Posted Oct 27, 2023

Participant flow

Participant flow — Overall Study
Milestone	Phase 1b	Phase II
Started	20	22
Completed	20	22
Not completed	0	0

Outcome measures

PrimaryPhase Ib Primary Outcome: Proportion of Patients Who Experienced DLTs Attributable to Palbociclib, Tucatinib, or Both

To measure safety and tolerability of tucatinib used in combination with palbociclib and letrozole, we will assess the proportion of subjects experiencing dose-limiting toxicities (DLTs) potentially attributable to tucatinib, palbociclib, or both drugs, and compare them to predefined safety thresholds. DLT was defined as any grade ≥ 3 nonhematologic adverse event, grade 3 neutropenia with fever, grade 3 thrombocytopenia with bleeding, or any hematologic toxicity grade ≥ 4 using NCI CTCAE version 4.03. Safety was considered clinically meaningfully altered if ≥60% of subjects experienced DLTs secondary palbociclib, ≥20% of subjects had toxicity secondary to tucatinib, or ≥50% of subjects had DLTs attributable to both drugs. If the proportion of patients with DLTs cross safety boundaries, doses of tucatinib, palbociclib or both medications would be decreased. Letrozole dose was kept constant for all study subjects.

Time frame:: 15 months (From date of first consent until final safety analysis of Phase Ib)
Reported as:: Number · percentage of participants

Phase Ib Primary Outcome: Proportion of Patients Who Experienced DLTs Attributable to Palbociclib, Tucatinib, or Both
percentage of participants	Baseline Starting Dose Patients for Phase Ib (Tucatinib 300mg, Palbociclib 125mg, Letrozole 2.5mg)	Dose-reduced Patients for Phase II (Tucatinib 300mg, Palbociclib 75mg, Letrozole 2.5mg)	Overall Patient Cohort
Phase Ib Primary Outcome: Proportion of Patients Who Experienced DLTs Attributable to Palbociclib, Tucatinib, or Both	100	65	100

PrimaryPhase II Primary Outcome: Median Progression-free Survival (mPFS)

To measure efficacy of tucatinib used in combination with palbociclib and letrozole, the median PFS (primary objective of Phase II) will be assessed. mPFS is defined as the time from allocation to the first documented disease progression according to RECIST 1.1, or death due to any cause, whichever occurs first. For subjects with brain metastatic disease enrolled in the study, assessment of bi-compartmental mPFS in the non-CNS and CNS compartments, defined as the time from allocation to the first documented disease progression according to RECIST 1.1 and/or RANO-BM criteria, or death due to any cause, whichever occurs first. For patient with CNS metastases who had an event of isolated CNS progression, underwent local therapy, and remained on study per protocol, mPFS was calculated as the time from the start of treatment until the first CNS progression.

Time frame:: 4 years (data cutoff of PFS calculation was when PFS became mature according to study statistician)
Reported as:: Median · months

Phase II Primary Outcome: Median Progression-free Survival (mPFS)
months	Overall Patient Cohort	CNS Cohort	Non-CNS Cohort
Phase II Primary Outcome: Median Progression-free Survival (mPFS)	8.4 (6.6 to 10.8)	8.2 (5.4 to 20.1)	10.0 (7.2 to 14.9)

SecondaryPhase Ib Secondary Outcome: Tucatinib and Palbociclib AUC[0-6] Post Tucatinib and Palbociclib Dose

Pharmacokinetic (PK) assessments of blood levels of tucatinib and palbociclib will be performed on Cycle 1 Day 15 and Cycle 2 Day 1 of therapy in 20 participants enrolled in the phase Ib part of the study. Plasma samples will be collected to measure levels of tucatinib and its hydroxyl metabolite ONT-993, as well as levels of palbociclib and, if needed, its metabolites at steady state on Cycle 1 Day 15. The area under the curve (AUC) of the concentration vs. time plot is computed from 0 to 6 hours after the tucatinib and palbociclib dose.

Time frame:: 0, 0.5, 1, 2, 3, 4, and 6 hours post-dose
Reported as:: Mean · h*ng/mL

Phase Ib Secondary Outcome: Tucatinib and Palbociclib AUC[0-6] Post Tucatinib and Palbociclib Dose
h*ng/mL	Baseline Starting Dose Patients (1-20): Tucatinib in Combination With Palbociclib and Letrozole
Palbociclib	647 (183.6 to 1983)
Tucatinib	2433 (1289 to 4022)
ONT-993 (Tucatinib metabolite)	340 (156.5 to 943.1)

SecondaryPhase II Secondary Outcome: Palbociclib AUC[10-19] Post Tucatinib and Palbociclib Dose

Additional pharmacokinetic (PK) assessment will be done in 5 to 10 patients enrolled in phase II part of the study to evaluate the levels of tucatinib and palbociclib. These PKs will be done on Cycle 1 Day 9 and Cycle 2 Day 9. Prior to the first set of PKs, on Cycle 1 Days 1-8, patient will take palbociclib and letrozole; tucatinib will be on hold. Tucatinib will be started per usual study schedule after the first set of PKs is obtained on Day 9. Prior to the second set of PKs, on Cycle 2 Days 1-8, patient will take palbociclib, letrozole and tucatinib (all study drugs) per usual study schedule. On the day prior to PK evaluation (Day 8 of Cycle 1 and Day 8 of Cycle 2), patient should consume high calorie / high fat meal and take study drugs. On the next day, plasma samples will be collected to measure PKs at 10, 13, 16 and 19 hrs +/- 10 minutes post dose.

Time frame:: 10, 13, 16, and 19 hours post-dose
Reported as:: Mean · h*ng/mL

Phase II Secondary Outcome: Palbociclib AUC[10-19] Post Tucatinib and Palbociclib Dose
h*ng/mL	Overall Patient Cohort
Phase II Secondary Outcome: Palbociclib AUC[10-19] Post Tucatinib and Palbociclib Dose	656 (506 to 1108)

SecondaryPhase II Secondary Outcome: Clinical Benefit Rate (CBR)

Clinical benefit rate (CBR) was assessed in patients with measurable lesions and defined as the proportion of patients with complete response, partial response, or stable disease for 6 months or more. It is one of the parameters used to assess tumor response in this study and was evaluated using RECIST 1.1 (and/or RANO-BM for patients with CNS disease).

Time frame:: 4 years
Reported as:: Number · percentage of participants

Phase II Secondary Outcome: Clinical Benefit Rate (CBR)
percentage of participants	Patients With Measurable Lesions (n=27)
Phase II Secondary Outcome: Clinical Benefit Rate (CBR)	70.4

SecondaryPhase II Secondary Outcome: Overall Response Rate (ORR)

Overall response rate (ORR) is defined as the proportion of subjects who had complete or partial response by RECIST 1.1 (and/or RANO-BM for patients with CNS disease).

Time frame:: 4 years
Reported as:: Number · percentage of participants

Phase II Secondary Outcome: Overall Response Rate (ORR)
percentage of participants	Patients With Measurable Lesions (n=27)
Phase II Secondary Outcome: Overall Response Rate (ORR)	44.5

SecondaryPhase II Secondary Outcome: Median Duration of Response (mDOR)

Median duration of response (mDOR) is defined as the time from enrollment in the clinical trial until objective tumor progression or death, whichever occurs first.

Time frame:: 4 years
Reported as:: Median · months

Phase II Secondary Outcome: Median Duration of Response (mDOR)
months	Patients With Measurable Lesions (n=27)
Phase II Secondary Outcome: Median Duration of Response (mDOR)	13.9 (5.51 to 31.8)

Adverse events

Collected over Approximately 1 year. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Phase Ib	0/20 (0%)	9/20 (45%)	20/20 (100%)
Phase II	0/22 (0%)	7/22 (31.8%)	22/22 (100%)

Most frequent serious events

Showing 10 of 22

Most frequent serious events
Event	Phase Ib	Phase II
PainGeneral disorders	2/20	0/22
SepsisInfections and infestations	1/20	1/22
Abdominal DistensionGastrointestinal disorders	1/20	0/22
Abdominal PainGastrointestinal disorders	1/20	0/22
AST IncreaseInvestigations	1/20	0/22
ALT IncreaseInvestigations	1/20	0/22
ConstipationGastrointestinal disorders	1/20	0/22
DyspneaRespiratory, thoracic and mediastinal disorders	1/20	0/22
Skin InfectionInfections and infestations	1/20	0/22
Lung Infection (Pneumonia)Respiratory, thoracic and mediastinal disorders	1/20	0/22

Most frequent other events

Showing 10 of 71

Most frequent other events
Event	Phase Ib	Phase II
Neutrophil Count, DecreasedInvestigations	17/20	16/22
DiarrheaGastrointestinal disorders	11/20	16/22
FatigueGeneral disorders	13/20	14/22
PainGeneral disorders	12/20	10/22
InfectionInfections and infestations	12/20	6/22
White Blood Cell Count DecreasedInvestigations	11/20	5/22
NauseaGastrointestinal disorders	11/20	12/22
VomitingGastrointestinal disorders	10/20	6/22
MucositisInfections and infestations	9/20	2/22
AnemiaBlood and lymphatic system disorders	7/20	3/22

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)	Phase Ib	Phase II	Total
<=18 years	0	0	0
Between 18 and 65 years	17	16	33
>=65 years	3	6	9

Age, Continuous
Age, Continuous(years)	Phase Ib	Phase II	Total
Mean	51 ± 11.55	53.12 ± 15.49	51.91 ± 13.60

Sex: Female, Male
Sex: Female, Male(Participants)	Phase Ib	Phase II	Total
Female	20	22	42
Male	0	0	0

Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)	Phase Ib	Phase II	Total
Hispanic or Latino	6	5	11
Not Hispanic or Latino	14	17	31
Unknown or Not Reported	0	0	0

Race (NIH/OMB)
Race (NIH/OMB)(Participants)	Phase Ib	Phase II	Total
American Indian or Alaska Native	0	0	0
Asian	0	1	1
Native Hawaiian or Other Pacific Islander	0	0	0
Black or African American	1	1	2
White	19	18	37
More than one race	0	1	1
Unknown or Not Reported	0	1	1

Region of Enrollment
Region of Enrollment(participants)	Phase Ib	Phase II	Total
United States	20	22	42

Study locations

6 sites

University of Arizona
Tucson, Arizona 85724, United States
University of Colorado Denver
Aurora, Colorado 80045, United States
Northwestern University
Chicago, Illinois 60611, United States
New Mexico Cancer Care Alliance
Albuquerque, New Mexico 87131, United States
Stony Brook University
Stony Brook, New York 11794, United States
University of Texas Health Science Center San Antonio
San Antonio, Texas 78229, United States

References and documents

Publications

Shagisultanova E, Crump LS, Borakove M, Hall JK, Rasti AR, Harrison BA, Kabos P, Lyons TR, Borges VF. Triple Targeting of Breast Tumors Driven by Hormonal Receptors and HER2. Mol Cancer Ther. 2022 Jan;21(1):48-57. doi: 10.1158/1535-7163.MCT-21-0098. Epub 2021 Nov 2. PubMed 34728571 ↗

Study documents

Protocol, analysis plan and consent form · Mar 23, 2020

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Nov 13, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT03054363
Lead sponsor: University of Colorado, Denver
Collaborators: Pfizer, Cascadian Therapeutics Inc., Criterium, Inc.
Responsible party: Sponsor
First posted: Feb 15, 2017
Start date: Nov 27, 2017
Primary completion: Jan 17, 2023
Completion: Feb 7, 2023
Results posted: Oct 27, 2023
Last update: Nov 13, 2023

Study contacts

Elena Shagisultanova, MD, PhD

principal investigator · University of Colorado, Denver

Oversight

Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

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