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
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.
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.
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 →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.
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Has confirmed inflammatory breast cancer by using international consensus criteria:
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
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:
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.
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
Given IV
Also known as: Keytruda, Lambrolizumab, MK-3475, SCH 900475
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)
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)
Mar 2017\~ Sept 2025. All recruitment was done at The University of Texas MD Anderson Cancer Center.
| Milestone | Pembrolizumab + Hormonal Therapy for HR+ Localized IBC Without pCR After Neoadjuvant Chemo |
|---|---|
| Started | 31 |
| Completed | 8 |
| Not completed | 23 |
| Withdrew: Adverse event | 12 |
| Withdrew: Withdrawal by subject | 1 |
| Withdrew: Financial issue | 2 |
| Withdrew: Clinical progression | 8 |
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.
| years | Pembrolizumab + Hormonal Therapy for HR+ Localized IBC Without pCR After Neoadjuvant Chemo |
|---|---|
| Disease Free Survival (DFS) | 4.22 (2.17 to NA) |
Number of participants experiencing treatment-related adverse events, graded according to CTCAE v4.0.
| Participants | Pembrolizumab + Hormonal Therapy for HR+ Localized IBC Without pCR After Neoadjuvant Chemo |
|---|---|
| Abdominal pain | 1 |
| Alanine aminotransferase increased | 1 |
| Anorexia | 1 |
| Arthralgia | 7 |
| Aspartate aminotransferase increased | 1 |
| Colitis | 4 |
| Cough | 2 |
| Diarrhea | 3 |
| Dry mouth | 1 |
| Dyspnea | 1 |
| Esophagitis | 1 |
| Fatigue | 7 |
| Hyperglycemia | 1 |
| Hyperkalemia | 1 |
| Hypertriglyceridemia | 1 |
| Hypothyroidism | 9 |
| Positive ANA antibody | 1 |
| Joint effusion | 1 |
| Lymphocyte count decreased | 2 |
| Myalgia | 2 |
| Nausea | 3 |
| Osteoporosis | 1 |
| Palmar-plantar erythrodysesthesia syndrome | 1 |
| Pneumonitis | 4 |
| Pruritus | 2 |
| Rash maculo-papular | 3 |
| Urinary tract infection | 1 |
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.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Pembrolizumab + Hormonal Therapy for HR+ Localized IBC Without pCR After Neoadjuvant Chemo | 9/31 (29%) | 6/31 (19.4%) | 28/31 (90.3%) |
| Event | Pembrolizumab + Hormonal Therapy for HR+ Localized IBC Without pCR After Neoadjuvant Chemo |
|---|---|
| ColitisGastrointestinal disorders | 2/31 |
| DiarrheaGastrointestinal disorders | 2/31 |
| PneumonitisRespiratory, thoracic and mediastinal disorders | 2/31 |
| HyperglycemiaMetabolism and nutrition disorders | 1/31 |
| Back painMusculoskeletal and connective tissue disorders | 1/31 |
| CoughRespiratory, thoracic and mediastinal disorders | 1/31 |
| Flank PainMusculoskeletal and connective tissue disorders | 1/31 |
| Rash maculo-papularSkin and subcutaneous tissue disorders | 1/31 |
| Event | Pembrolizumab + Hormonal Therapy for HR+ Localized IBC Without pCR After Neoadjuvant Chemo |
|---|---|
| ArthralgiaMusculoskeletal and connective tissue disorders | 11/31 |
| HypothyroidismEndocrine disorders | 9/31 |
| FatigueGeneral disorders | 9/31 |
| HypertensionVascular disorders | 9/31 |
| NauseaGastrointestinal disorders | 6/31 |
| MyalgiaMusculoskeletal and connective tissue disorders | 5/31 |
| Skin infectionInfections and infestations | 4/31 |
| Upper respiratory infectionInfections and infestations | 4/31 |
| Rash maculo-papularSkin and subcutaneous tissue disorders | 4/31 |
| DiarrheaGastrointestinal disorders | 3/31 |
| Age, Categorical(Participants) | Pembrolizumab + Hormonal Therapy for HR+ Localized IBC Without pCR After Neoadjuvant Chemo |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 27 |
| >=65 years | 4 |
| Sex: Female, Male(Participants) | Pembrolizumab + Hormonal Therapy for HR+ Localized IBC Without pCR After Neoadjuvant Chemo |
|---|---|
| Female | 31 |
| Male | 0 |
| Race (NIH/OMB)(Participants) | Pembrolizumab + Hormonal Therapy for HR+ Localized IBC Without pCR After Neoadjuvant Chemo |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 1 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 4 |
| White | 25 |
| More than one race | 1 |
| Unknown or Not Reported | 0 |
| Region of Enrollment(participants) | Pembrolizumab + Hormonal Therapy for HR+ Localized IBC Without pCR After Neoadjuvant Chemo |
|---|---|
| United States | 31 |
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Inflammatory Breast Neoplasms→
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