Pembrolizumab and Carboplatin in Treating Patients With Circulating Tumor Cells Positive Metastat… (NCT03213041) | Clinical Trial Compass
CompletedPhase 2
Pembrolizumab and Carboplatin in Treating Patients With Circulating Tumor Cells Positive Metastatic Breast Cancer
United States12 participantsStarted 2017-09-14
Plain-language summary
The purpose of the study is to evaluate the impact on progression-free survival (PFS) with the combination carboplatin - pembrolizumab in patients with CTC (circulating tumor cells) positive, HER2 negative metastatic breast cancer previously treated with anthracyclines and taxanes. Previous studies have indicated that recurrent breast cancers are more resistant to chemotherapy and maybe associated with a weak immune system. This study is investigating the use of an immune therapy drug, pembrolizumab, that has the ability to restore the capacity of controlling and killing cancer cells of an important component of your immune system called T-cells. Pembrolizumab has been found effective in other types of cancer and has already been approved by FDA for those indications, but the efficacy in breast cancer is still unknown. In this study, pembrolizumab will be combined with chemotherapy to increase the cancer cell killing. There is no control or placebo treatment in this study.
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:
* Patients must be:
* Hormone receptor (HR) negative and HER-2 negative (triple negative breast cancer \[TNBC\]) metastatic breast cancer and have not received prior chemotherapy for metastatic disease
* Demonstrated HER-2 negative MBC (0 or 1+ by immunohistochemistry \[IHC\] or non-amplified by fluorescence in situ hybridization \[FISH\]) according to American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAPA) guidelines
* Patients must be CTC positive (defined as CTCs \>= 5)
* Have measurable disease based on RECIST 1.1
* Be willing to provide archival tissue (if available) for correlative studies
* Note: The archived tumor tissue specimens may be from metastatic tumor specimen (first choice); in alternative, we can consider tissue from prior surgery or from prior diagnostic biopsy (second choice); unavailability of archived tissue will not render subject ineligible for study
* Have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) performance status
* Demonstrate adequate organ function, all screening labs should be performed within 14 days prior to registration
* Absolute neutrophil count (ANC) \>= 1,500 /mcL
* Platelet \>= 100,000 / mcL
* Hemoglobin \>= 9 g/dL or \>= 5.6 mmol/L without transfusion or erythropoietin (EPO) dependency (within 7 days of assessment)
* Serum creatinine =\< 1.5 X upper limit of normal (ULN) OR measured or calculated creatinine clearance (glomerular filtration ra…
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 combined pembrolizumab, an immunotherapy drug, with carboplatin chemotherapy specifically for metastatic breast cancer patients who had circulating tumor cells detected in their blood — does my current test profile, including my hormone receptor and HER2 status, look similar enough to the patients in this study that the results might be relevant to my situation?
2Since this was a Phase 2 trial, the main thing it was measuring was progression-free survival — meaning how long patients went without their cancer getting worse — what did the results actually show, and how does that compare to what I might expect from standard treatments available to me right now?
3This trial has already completed, so there should be published or available data — can you help me find those results, and are there any ongoing or follow-up Phase 3 trials building on this research that I might be eligible to consider?
4Carboplatin can have significant side effects like lowering blood counts and causing nausea, and pembrolizumab carries risks of immune-related reactions — given my overall health and where my cancer stands right now, how would you weigh those risks against the potential benefits of this combination approach?
5This trial specifically enrolled patients who tested positive for circulating tumor cells — have I been tested for those, and is that something worth discussing as part of figuring out which treatment path makes the most sense for me?
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.
What they're measuring
1
Progression Free Survival (PFS)
Timeframe: Every 9 weeks from the first study treatment, assessed up to 3 years