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
NCT02971748 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 36
Last updated 2026-01-22
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.
Conditions
- 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
Interventions
- BIOLOGICAL
-
Given IV
Sponsors & Collaborators
-
National Cancer Institute (NCI)
collaborator NIH -
M.D. Anderson Cancer Center
lead OTHER
Principal Investigators
-
Bora Lim, MD · M.D. Anderson Cancer Center
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2017-01-26
- Primary Completion
- 2025-12-10
- Completion
- 2027-12-31
- FDA Drug
- Yes
Countries
- United States
Study Locations
More Related Trials
-
Pembrolizumab, IRX-2, and Chemotherapy in Triple Negative Breast Cancer
NCT04373031 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE2
-
Study of Pembrolizumab (MK-3475) Versus Placebo in Combination With Neoadjuvant Chemotherapy & Adjuvant Endocrine Therapy in the Treatment of Early-Stage Estrogen Receptor-Positive, Human Epidermal Growth Factor Receptor 2-Negative (ER+/HER2-) Breast Cancer (MK-3475-756/KEYNOTE-756)
NCT03725059 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE3
-
Testing MK-3475 (Pembrolizumab) as Adjuvant Therapy for Triple Receptor-Negative Breast Cancer
NCT02954874 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE3
-
Pembrolizumab + Paclitaxel +/- Bevacizumab for Triple-negative Breast Cancer
NCT06976944 ·Status: RECRUITING ·Phase: PHASE2
-
Trial of Nivolumab With Chemotherapy as Neoadjuvant Treatment in Inflammatory Breast Cancer (IBC)
NCT03742986 ·Status: COMPLETED ·Phase: PHASE2
-
Breast Cancer Study of Preoperative Pembrolizumab + Radiation
NCT03366844 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE1/PHASE2
-
Pembrolizumab and Monoclonal Antibody Therapy in Advanced Cancer
NCT02318901 ·Status: TERMINATED ·Phase: PHASE1/PHASE2
-
A Phase II Study Evaluating the Efficacy and Safety of Pembrolizumab in Combination With Chemotherapy as Neoadjuvant Therapy for Triple-negative Breast Cancer
NCT05681728 ·Status: UNKNOWN ·Phase: PHASE2
-
Pembrolizumab and Exemestane/ Leuprolide in Premenopausal HR+/ HER2- Locally Advanced or Metastatic Breast Cancer
NCT02990845 ·Status: TERMINATED ·Phase: PHASE1/PHASE2
-
Pembrolizumab + Paclitaxel in HR+/HER2- Non-luminal (by PAM50) Advanced Breast Cancer After CDK4/6 Inhibitor Progression
NCT04251169 ·Status: TERMINATED ·Phase: PHASE2
-
Study of Radiotherapy and Pembrolizumab in People With Adrenocortical Carcinoma
NCT06066333 ·Status: RECRUITING ·Phase: PHASE2
-
Study to Assess Effectiveness of Giving Combination of Standard Chemotherapy Drugs Versus Combination of Standard Chemotherapy and New Drug Ixabepilone When Given Before Surgical Removal of Early Stage Breast Cancer
NCT00455533 ·Status: COMPLETED ·Phase: PHASE2
-
Study of Patritumab Deruxtecan Plus Pembrolizumab With Other Anticancer Agents in Participants With High-Risk Early-Stage Triple-Negative or Hormone Receptor-Low Positive/HER-2 Negative Breast Cancer (MK-1022-010, HERTHENA-Breast-03)
NCT06797635 ·Status: RECRUITING ·Phase: PHASE2
-
Pembrolizumab and Ruxolitinib Phosphate in Treating Patients With Metastatic Stage IV Triple Negative Breast Cancer
NCT03012230 ·Status: COMPLETED ·Phase: PHASE1
-
Effects of MK-3475 (Pembrolizumab) on the Breast Tumor Microenvironment in Triple Negative Breast Cancer
NCT02977468 ·Status: RECRUITING ·Phase: PHASE1
-
Panitumumab, Nab-paclitaxel and Carboplatin for HER2 Negative Inflammatory Breast Cancer
NCT01036087 ·Status: COMPLETED ·Phase: PHASE2
-
Study of Pembrolizumab (MK-3475) Plus Chemotherapy vs Placebo Plus Chemotherapy as Neoadjuvant Therapy and Pembrolizumab vs Placebo as Adjuvant Therapy in Participants With Triple Negative Breast Cancer (TNBC) (MK-3475-522/KEYNOTE-522)
NCT03036488 ·Status: COMPLETED ·Phase: PHASE3
-
Neoadjuvant Pembrolizumab(Pbr)/Nab-Paclitaxel Followed by Pbr/Epirubicin/Cyclophosphamide in TNBC
NCT03289819 ·Status: COMPLETED ·Phase: PHASE2
-
Pembrolizumab vs. Observation in People With Triple-negative Breast Cancer Who Had a Pathologic Complete Response After Chemotherapy Plus Pembrolizumab
NCT05812807 ·Status: RECRUITING ·Phase: PHASE3
-
Study of Pembrolizumab Plus Fulvestrant in Hormone Receptor Positive, HER-2 Negative Advanced/Metastatic Breast Cancer Patients
NCT03393845 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE2
-
Safety and Efficacy Study of Pembrolizumab (MK-3475) in Combination With Chemotherapy as Neoadjuvant Treatment for Participants With Triple Negative Breast Cancer (TNBC) (MK-3475-173/KEYNOTE-173)
NCT02622074 ·Status: COMPLETED ·Phase: PHASE1
-
Phase II Study of Pembrolizumab and Nab-paclitaxel in HER-2 Negative Metastatic Breast Cancer
NCT02752685 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE2
-
Evaluation of Specific Biomarkers in Primary Invasive Breast Cancer
NCT01476111 ·Status: TERMINATED
-
Pembrolizumab and Oral Metronomic Cyclophosphamide in Patients With Chest Wall Breast Cancer
NCT03971045 ·Status: RECRUITING ·Phase: PHASE2
-
Pembrolizumab and Chemotherapy Treatment or no Treatment Guided by the Level of TILs in Resected Early-stage TNBC
NCT06078384 ·Status: RECRUITING ·Phase: PHASE2