Pembrolizumab in Treating Patients With Stage IV Metastatic or Recurrent Inflammatory Breast Cancer or Triple-Negative Breast Cancer Who Have Achieved Clinical Response or Stable Disease to Prior Chemotherapy
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- STATUS
- Recruiting
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- End date
- Dec 31, 2024
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- participants needed
- 35
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- sponsor
- M.D. Anderson Cancer Center
Summary
This phase II trial studies how well pembrolizumab works in treating patients with stage IV inflammatory breast cancer or triple-negative breast cancer that has spread to other places in the body (metastatic) or has come back (recurrent), and who have achieved clinical response or stable disease to prior 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.
Description
PRIMARY OBJECTIVES:
I. To assess the efficacy of pembrolizumab (MK-3475) as a single agent in patients with metastatic inflammatory breast cancer (IBC) and non-IBC triple-negative breast cancer (TNBC).
EXPLORATORY OBJECTIVES:
I. To investigate the association between biomarkers in the peripheral blood and tumor tissue, such as PD-L1 expression, with safety and efficacy for IBC or non-IBC TNBC patients treated with MK-3475.
II. To determine the disease control rate of metastatic IBC or non-IBC TNBC patients who have achieved clinical response or stable disease to the systemic therapy.
III. To investigate the association between biomarkers and efficacy by ribonucleic acid (RNA)-sequencing of exosomes in blood and tumor for IBC or non-IBC TNBC patients.
- OUTLINE
Patients receive pembrolizumab intravenously (IV) over approximately 30 minutes on day 1. Courses 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 approximately 1 and 3 months.
Details
| Condition | Edema, Erythema, Estrogen Receptor Negative, HER2/Neu Negative, Peau d'Orange, Progesterone Receptor Negative, Recurrent Inflammatory Breast Carcinoma, Stage IV Inflammatory Breast Carcinoma, Triple-Negative Breast Carcinoma |
|---|---|
| Treatment | laboratory biomarker analysis, Pembrolizumab, MK-3475, Follow Up/Phone Call |
| Clinical Study Identifier | NCT02411656 |
| Sponsor | M.D. Anderson Cancer Center |
| Last Modified on | 7 October 2022 |
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.
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