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

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

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Pembrolizumab — BIOLOGICAL
  Given IV

Study Details

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.

Key Dates

Start date

Jan 26, 2017

Status verified

Jun 2026

Primary completion

Dec 10, 2025

Completion

Dec 31, 2027

Study Design

Enrollment

36 participants (actual)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

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.

Primary Outcome Measure

Disease Free Survival (DFS) [ Time Frame: From treatment initiation through last available follow-up (up to approximately 9 years) ]

Locations (1)

Related coverage on Hipa.ai

• Pembrolizumab Shows 4.22 Years Median DFS in HR+ Localized IBC
  Pembrolizumab · Jan 22, 2026 · ClinicalTrials.gov

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