CompletedPhase 2

Pembrolizumab With Carboplatin Compared to Carboplatin Alone in Breast Cancer Patients With Chest Wall Disease

United States76 participantsStarted 2017-09-02

Plain-language summary

This is a phase II multicenter study including breast cancer patients with chest wall disease that is hormone resistant (estrogen receptor (ER) positive/progesterone receptor (PR) positive/human epidermal growth factor receptor 2 (HER2) negative breast cancer with progressive disease on 2 prior lines of hormonal therapy) or triple negative (ER negative/PR negative/HER2 negative, TNBC). A companion translational study is operating concurrently with the study described above. In this study, biomarker research to be performed on tumor biopsies and peripheral blood samples will be performed to explore the immunologic and genomic mechanism of action underlying treatment with pembrolizumab and carboplatin versus carboplatin alone. This protocol includes tissue and blood correlative exploratory endpoints including changes in tumor PD-L1 (programmed death ligand 1) gene expression, tumor and peripheral blood immune composition and cytokine expression, plasma tumor DNA, circulating tumor cells, and tumor myelocytomatosis (MYC) oncogene expression using tumor biopsy and peripheral blood testing before and after treatment; correlations with these markers and disease control rate will be assessed.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. Advanced breast cancer with locally recurrent chest wall disease not amenable to surgical excision with curative intent.
✓. Distant sites of disease are allowed
✓. Prior radiation to the chest wall is not required
✓. The following disease subtypes are eligible:
✓. Triple negative disease (defined as ER \< 10%, PR \< 10%, HER2 negative)
✓. Hormone receptor positive, HER2 negative disease with evidence of progression on at least two prior lines of hormone therapy, unless, per treating investigator's judgement, is not considered a candidate for further endocrine therapy
✓. HER2 positive disease with evidence of disease progression on trastuzumab, pertuzumab, Trastuzumab emtansine (T-DM1), and oral tyrosine kinase inhibitor unless contraindicated with no other HER2 targeted therapy options available. Patients in this category will be classified by ER status
✓. Any number of prior lines of therapy are allowed. a Prior platinum based therapy is allowed in the following settings:

Exclusion criteria

What they're measuring

Disease Control Rate (DCR) at 18 Weeks

Timeframe: Up to 18 weeks

Median Progression Free Survival (PFS) at 18 Weeks

Timeframe: Up to 18 weeks

Trial details

NCT IDNCT03095352

SponsorLaura Huppert, MD, BA

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-11-30

Results submitted2025-11-30

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