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Active, not recruitingNCT02971748Updated Jun 11, 2026Results posted

Pembrolizumab in Treating Patients With Hormone Receptor Positive, Localized Inflammatory Breast Cancer Who Are Receiving Hormone Therapy and Did Not Achieve a Pathological Complete Response to Chemotherapy

A Phase 2 interventional study of Pembrolizumab in Anatomic Stage IIIB Breast Cancer AJCC v8, Anatomic Stage IIIC Breast Cancer AJCC v8 and Breast Inflammatory Carcinoma, sponsored by M.D. Anderson Cancer Center. Active, not recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-11.

Sponsored by M.D. Anderson Cancer Center · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
36
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

This phase II trial studies how well pembrolizumab works in treating patients with hormone receptor positive inflammatory breast cancer that has not spread to other parts of the body, who are receiving hormone therapy and did not achieve a pathological complete response to chemotherapy. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread.

Read the detailed description

PRIMARY OBJECTIVES:

I. To determine the disease free survival (DFS) at 2 years of patients with maintenance therapy using pembrolizumab in combination with standard adjuvant hormonal therapy.

II. To determine the safety and toxicity profile of primary inflammatory breast cancer (IBC) patients who received combination of pembrolizumab and hormone receptor blockade.

EXPLORATORY OBJECTIVES:

I. To investigate the association between immune related biomarkers in the peripheral blood and tumor tissue, such as PD-L1 expression, with safety and efficacy for IBC patients treated with pembrolizumab.

OUTLINE:

Patients receive pembrolizumab intravenously (IV) over 30 minutes on day 1. Cycles repeat every 21 days for up to 24 months in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up at 1 and 24 months.

02

Conditions studied

  • Anatomic Stage IIIB Breast Cancer AJCC v8
  • Anatomic Stage IIIC Breast Cancer AJCC v8
  • Breast Inflammatory Carcinoma
  • Prognostic Stage IIIB Breast Cancer AJCC v8
  • Prognostic Stage IIIC Breast Cancer AJCC v8
03

In context

Inflammatory Breast Neoplasms

84 studies on the registry are indexed under Inflammatory Breast Neoplasms; 7 are open to participants now.

This study's enrollment of 36 is below the median of 54 across 74 interventional studies indexed under Inflammatory Breast Neoplasms.

Browse Inflammatory Breast Neoplasms studies →

Lead sponsor

M.D. Anderson Cancer Center is the lead sponsor of 2,999 studies on the registry; 581 are open to participants now.

Of its 599 completed or terminated interventional studies of FDA-regulated products, 402 (67%) have results posted.

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

04

Who can participate

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

Inclusion criteria

  1. Is willing and able to provide written informed consent for the trial.
  2. Is a female or male and >/= 18 years of age
  3. Has histological confirmation of breast carcinoma.
  4. Has confirmed inflammatory breast cancer by using international consensus criteria:

    • Onset: Rapid onset of breast erythema, edema and/or peau d'orange, and/or warm breast, with/without an underlying breast mass
    • Duration: History of such findings no more than 6 months
    • Extent: Erythema occupying at least 1/3 of whole breast
    • Pathology: Pathologic confirmation of invasive carcinoma
  5. Did not achieve pathological complete response (pCR) to any chemotherapy that was given with the intention to induce best response prior surgery. pCR is defined as the current American Joint Committee on Cancer (AJCC) breast cancer staging.
  6. Is HER2 normal, defined as HER2 0 or 1+ by IHC and negative by FISH if performed; or HER2 is 2+ by IHC and negative by FISH; or HER2 negative by FISH if IHC is not performed.
  7. Has positive ER or PR status. ER or PR >/= 10%
  8. Has a performance status of 0-1 on the ECOG Performance Scale.
  9. Has adequate organ function as determined by the following laboratory values:

    ANC >/= 1,500 /mcL, Platelets >/=100,000 /mcL, Hgb >/= 9 g/dL, creatinine levels \< 1.5 x ULN, Total bilirubin \</= 1.5 x ULN, ALT and AST \</= 2.5 x ULN

  10. Participants of reproductive potential must agree to avoid becoming pregnant or impregnating a partner, respectively, while receiving study drug and for 120 days after the last dose of study drug by complying with one of the following: (1) practice abstinence† from heterosexual activity; OR (2) use (or have their partner use) acceptable contraception during heterosexual activity.

Acceptable methods of contraception are: Single method (one of the following is acceptable): (1) intrauterine device (IUD); (2) vasectomy of a female participant's male partner; (3) contraceptive rod implanted into the skin. Combination method (requires use of two of the following): (1) diaphragm with spermicide (cannot be used in conjunction with cervical cap/spermicide); (2) cervical cap with spermicide (nulliparous women only); (3) contraceptive sponge (nulliparous women only); (4) male condom or female condom (cannot be used together); (5) hormonal contraceptive: oral contraceptive pill (estrogen/progestin pill or progestin-only pill), contraceptive skin patch, vaginal contraceptive ring, or subcutaneous contraceptive injection.

Female participants will be considered of non-reproductive potential if they are either:

(1) postmenopausal (defined as at least 12 months with no menses without an alternative medical cause; in women \< 45 years of age a high follicle stimulating hormone (FSH) level in the postmenopausal range may be used to confirm a post-menopausal state in women not using hormonal contraception or hormonal replacement therapy. In the absence of 12 months of amenorrhea, a single FSH measurement is insufficient.); OR (2) have had a hysterectomy and/or bilateral oophorectomy, bilateral salpingectomy or bilateral tubal ligation/occlusion, at least 6 weeks prior to screening; OR (3) has a congenital or acquired condition that prevents childbearing.

Male participants will be considered to be of non-reproductive potential if they have azoospermia (whether due to having had a vasectomy or due to an underlying medical condition).

11. Has negative serum or urine pregnancy test for subjects of childbearing potential within 10 days before first dose.

12. Have completed radiation (if candidate for post-mastectomy radiation) or plans to begin radiation and endocrine therapy within 28 days.

13. If the participant has already started hormonal blockade therapy after radiation as adjuvant therapy, the patient is eligible as long as the hormonal therapy was initiated no more than 6 months before the screening day and the participant can start the study drug within 4 weeks since the completion of screening.

Exclusion criteria

Exclusion Criteria:

  1. Is currently participating in a study of an investigational anti-cancer agent.
  2. Has a diagnosis of immunodeficiency or any other form of immunosuppressive therapy.
  3. Has not recovered from adverse events due to prior therapies, i.e. monoclonal antibody, chemotherapy, targeted small molecule therapy, radiation therapy, or surgery.

    - Note: Participants with ≤ Grade 2 neuropathy, alopecia and general disorders and administration site conditions (per CTCAE version 4.0) are an exception to this criterion and may qualify for the study.

  4. Has a known history of prior malignancy with the exception of basal cell carcinoma of the skin, superficial bladder cancer, squamous cell carcinoma of the skin, or in situ cervical cancer, and has undergone potentially curative therapy and has no evidence of recurrence over the last 1 year since completion of curative therapy.
  5. Has an active autoimmune disease requiring systemic treatment within the past 3 months or a documented history of clinically severe autoimmune disease, or immunosuppressive agents. Participants with vitiligo or resolved childhood asthma/atopy would be an exception to this rule. Participants that require intermittent use of bronchodilators, inhaled steroid or local steroid injections to the skin would not be excluded from the study. Participants with hypothyroidism stable on hormone replacement or Sjögren's syndrome will not be excluded from the study.
  6. Has a history of (non-infectious) pneumonitis that required steroids or current pneumonitis.
  7. Has an active infection requiring systemic therapy.
  8. Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
  9. Has received prior therapy with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-Cytotoxic T-lymphocyte-associated antigen-4 (CTLA-4) antibody (including ipilimumab or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways).
  10. Has a known history of Human Immunodeficiency Virus (HIV).
  11. Has a known active Hepatitis B or Hepatitis C
  12. Have received a live vaccine within 30 days prior to the first dose of trial treatment.
  13. Gastrointestinal tract disease or defect or previous history of colitis.
  14. Has proven or suspected distant metastasis that involves occurrence of breast cancer outside of loco-regional breast and lymph nodes area.
  15. Participants requiring daily corticosteroids either via po or infusion
  16. Myocardial infarction within 6 months before starting therapy, symptomatic congestive heart failure (New York Heart Association > class II), unstable angina, or unstable cardiac arrhythmia requiring medication.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
36 participants (actual)

Study arms

  • Experimental
    Treatment (pembrolizumab)

    Patients receive pembrolizumab IV over 30 minutes on day 1. Cycles repeat every 21 days for up to 24 months in the absence of disease progression or unacceptable toxicity.

    Biological: Pembrolizumab

Interventions

  • BiologicalPembrolizumab

    Given IV

    Also known as: Keytruda, Lambrolizumab, MK-3475, SCH 900475

06

What researchers measure

Primary outcomes

  1. Disease Free Survival (DFS)

    Disease-free survival (DFS) is defined as the time from treatment initiation to recurrence of disease or death from any cause. Patients without an event were censored at their last disease assessment.

    Time frame: From treatment initiation through last available follow-up (up to approximately 9 years)

  2. Participants With Treatment-Related Adverse Events

    Number of participants experiencing treatment-related adverse events, graded according to CTCAE v4.0.

    Time frame: From first dose through 30 days after last dose (up to approximately 25 months)

07

Results

Posted Jan 22, 2026

Participant flow

Mar 2017\~ Sept 2025. All recruitment was done at The University of Texas MD Anderson Cancer Center.

Participant flow — Overall Study
MilestonePembrolizumab + Hormonal Therapy for HR+ Localized IBC Without pCR After Neoadjuvant Chemo
Started31
Completed8
Not completed23
Withdrew: Adverse event12
Withdrew: Withdrawal by subject1
Withdrew: Financial issue2
Withdrew: Clinical progression8

Outcome measures

PrimaryDisease Free Survival (DFS)

Disease-free survival (DFS) is defined as the time from treatment initiation to recurrence of disease or death from any cause. Patients without an event were censored at their last disease assessment.

Time frame:
From treatment initiation through last available follow-up (up to approximately 9 years)
Reported as:
Median · years
Disease Free Survival (DFS)
yearsPembrolizumab + Hormonal Therapy for HR+ Localized IBC Without pCR After Neoadjuvant Chemo
Disease Free Survival (DFS)4.22 (2.17 to NA)
PrimaryParticipants With Treatment-Related Adverse Events

Number of participants experiencing treatment-related adverse events, graded according to CTCAE v4.0.

Time frame:
From first dose through 30 days after last dose (up to approximately 25 months)
Reported as:
Count of participants · Participants
Participants With Treatment-Related Adverse Events
ParticipantsPembrolizumab + Hormonal Therapy for HR+ Localized IBC Without pCR After Neoadjuvant Chemo
Abdominal pain1
Alanine aminotransferase increased1
Anorexia1
Arthralgia7
Aspartate aminotransferase increased1
Colitis4
Cough2
Diarrhea3
Dry mouth1
Dyspnea1
Esophagitis1
Fatigue7
Hyperglycemia1
Hyperkalemia1
Hypertriglyceridemia1
Hypothyroidism9
Positive ANA antibody1
Joint effusion1
Lymphocyte count decreased2
Myalgia2
Nausea3
Osteoporosis1
Palmar-plantar erythrodysesthesia syndrome1
Pneumonitis4
Pruritus2
Rash maculo-papular3
Urinary tract infection1

Adverse events

Collected over All-cause mortality was assessed for up to 2 years after treatment discontinuation. Adverse events were assessed from first protocol-specific intervention through 30 days after last pembrolizumab dose (up to approximately 25 months). Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Pembrolizumab + Hormonal Therapy for HR+ Localized IBC Without pCR After Neoadjuvant Chemo9/31 (29%)6/31 (19.4%)28/31 (90.3%)
Most frequent serious events
Most frequent serious events
EventPembrolizumab + Hormonal Therapy for HR+ Localized IBC Without pCR After Neoadjuvant Chemo
ColitisGastrointestinal disorders2/31
DiarrheaGastrointestinal disorders2/31
PneumonitisRespiratory, thoracic and mediastinal disorders2/31
HyperglycemiaMetabolism and nutrition disorders1/31
Back painMusculoskeletal and connective tissue disorders1/31
CoughRespiratory, thoracic and mediastinal disorders1/31
Flank PainMusculoskeletal and connective tissue disorders1/31
Rash maculo-papularSkin and subcutaneous tissue disorders1/31
Most frequent other events
Showing 10 of 74
Most frequent other events
EventPembrolizumab + Hormonal Therapy for HR+ Localized IBC Without pCR After Neoadjuvant Chemo
ArthralgiaMusculoskeletal and connective tissue disorders11/31
HypothyroidismEndocrine disorders9/31
FatigueGeneral disorders9/31
HypertensionVascular disorders9/31
NauseaGastrointestinal disorders6/31
MyalgiaMusculoskeletal and connective tissue disorders5/31
Skin infectionInfections and infestations4/31
Upper respiratory infectionInfections and infestations4/31
Rash maculo-papularSkin and subcutaneous tissue disorders4/31
DiarrheaGastrointestinal disorders3/31

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)Pembrolizumab + Hormonal Therapy for HR+ Localized IBC Without pCR After Neoadjuvant Chemo
<=18 years0
Between 18 and 65 years27
>=65 years4
Sex: Female, Male
Sex: Female, Male(Participants)Pembrolizumab + Hormonal Therapy for HR+ Localized IBC Without pCR After Neoadjuvant Chemo
Female31
Male0
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Pembrolizumab + Hormonal Therapy for HR+ Localized IBC Without pCR After Neoadjuvant Chemo
American Indian or Alaska Native0
Asian1
Native Hawaiian or Other Pacific Islander0
Black or African American4
White25
More than one race1
Unknown or Not Reported0
Region of Enrollment
Region of Enrollment(participants)Pembrolizumab + Hormonal Therapy for HR+ Localized IBC Without pCR After Neoadjuvant Chemo
United States31
08

Study locations

1 site
  • M D Anderson Cancer Center
    Houston, Texas 77030, United States
09

References and documents

Study documents

  • Protocol and statistical analysis plan · Nov 17, 2023

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

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 11, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT02971748
Lead sponsor
M.D. Anderson Cancer Center
Collaborators
National Cancer Institute (NCI)
Responsible party
Sponsor
First posted
Nov 23, 2016
Start date
Jan 26, 2017
Primary completion
Dec 10, 2025
Completion
Dec 31, 2027 (estimated)
Results posted
Jan 22, 2026
Last update
Jun 11, 2026

Study contacts

Bora Lim, MD
principal investigator · M.D. Anderson Cancer Center

Oversight

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

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This study is active, not recruiting, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.

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