Standard of Care Chemotherapy Plus Pembrolizumab for Breast Cancer (NCT02734290) | Clinical Trial Compass
Active — 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 range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 requir…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is in Phase 1/2 and is no longer enrolling new patients — does that mean there are already some early safety and tolerability results available that could help us understand how well pembrolizumab works alongside standard chemotherapy for triple negative breast cancer?
2Since one of the main things this trial is measuring is how many patients had to stop treatment due to serious side effects, what kinds of adverse events has my doctor seen or heard about with this combination, and how would that risk compare to my standard chemotherapy options alone?
3The trial also tracks whether patients can get through chemotherapy without a significant delay of more than 21 days — given my current health and schedule, does my doctor think I could realistically handle a regimen that combines an immunotherapy drug like pembrolizumab with standard chemotherapy?
4Since this trial is active but no longer recruiting, are there any published or preliminary results from it that my doctor could review to help us decide whether a similar pembrolizumab-based approach might be worth pursuing through another available study or approved treatment pathway?
5For triple negative breast cancer specifically, how does adding pembrolizumab to standard chemotherapy in a trial like this compare to just starting with the standard of care alone — and is there a reason my doctor would recommend one path over the other given where I am in my diagnosis?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.