Standard of Care Chemotherapy Plus Pembrolizumab for Breast Cancer (NCT02734290) | Clinical Trial Compass
Active ā Not RecruitingPhase 1/2
Standard of Care Chemotherapy Plus Pembrolizumab for Breast Cancer
United States29 participantsStarted 2016-02-23
Plain-language summary
The goal of this study is to establish the safety and tolerability of pembrolizumab when administered in combination with either of two chemotherapy regimens (weekly paclitaxel or capecitabine) in unresectable/metastatic triple negative breast cancer (MTNBC) patients.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
Be willing and able to provide written informed consent/assent for the trial.
* Be 18 years of age on day of signing informed consent.
* HER2-negative breast cancer (defined by immunohistochemistry (IHC) 0-1 (or) IHC 2 and in situ hybridization (ISH) HER2 / centromere on chromosome 17 (CEP17) \< 2.0);
* ER and PR-negative breast cancer (defined by IHC\<1%);
* Measurable metastatic or unresectable disease based on response evaluation criteria in solid tumours (RECIST) 1.1.
* Indicated for treatment with either weekly paclitaxel or oral capecitabine, as first or second-line chemotherapy in the metastatic/unresectable setting (as determined by the consenting investigator);
* Be willing to provide tissue from a newly obtained core or excisional biopsy of a tumor lesion. Newly-obtained is defined as a specimen obtained during screening. Archival tissue is acceptable if no intervening anti-neoplastic therapy has been administered, and if sufficient material is available for analysis (see section 8.0 for requirements);
* Have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) Performance Scale.
* Demonstrate adequate organ function as defined by protocol defined lab values
* Female subjects of childbearing potential must have a negative urine or serum pregnancy within 72 hours prior to receiving the first dose of study medication. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be requirā¦