Platinum in Treating Patients With Residual Triple-Negative Breast Cancer Following Neoadjuvant C… (NCT02445391) | Clinical Trial Compass
Active — Not RecruitingPhase 3
Platinum in Treating Patients With Residual Triple-Negative Breast Cancer Following Neoadjuvant Chemotherapy
United States, South Africa415 participantsStarted 2015-10-20
Plain-language summary
This randomized phase III trial studies how well cisplatin or carboplatin (platinum based chemotherapy) works compared to capecitabine in treating patients with remaining (residual) basal-like triple-negative breast cancer following chemotherapy after surgery (neoadjuvant). Drugs used in chemotherapy, such as cisplatin, carboplatin and capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. It is not yet known whether cisplatin or carboplatin is more effective than capecitabine in treating patients with residual triple negative basal-like breast cancer.
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.
ELIGIBILITY CRITERIA FOR SCREENING AND MOLECULAR PROFILING (STEP 0)
Inclusion Criteria:
* Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 within 2 weeks prior to screening
* Female and male patients must have histologically confirmed invasive breast cancer that meets the following criteria:
* Clinical stage II-III (American Joint Committee on Cancer \[AJCC\] 7th edition) at diagnosis, based on initial evaluation by clinical examination and/or breast imaging; no metastatic disease allowed
* ER- and PR- should meet one of the following criteria:
* =\< 10% cells stain positive, with weak intensity score (equivalent to Allred score =\< 3)
* =\< 1% cells stain positive, with weak or intermediate intensity score (equivalent to Allred score =\< 3)
* HER2 negative (not eligible for anti-HER2 therapy) will be defined as:
* Immunohistochemistry (IHC) 0, 1+ without in situ hybridization (ISH) HER2/neu chromosome 17 ratio OR
* IHC 2+ and ISH HER2/neu chromosome 17 ratio non-amplified with ratio less than 2.0 and if reported average HER2 copy number \< 6 signals/cells OR
* ISH HER2/neu chromosome 17 ratio non-amplified with ratio less than 2.0 and if reported average HER2 copy number \< 6 signals/cells without IHC
* NOTE: Patients that originally present with synchronous bilateral tumors are eligible provided both tumors are TNBC, and at least one of them fulfills the remainder eligibility criteria of the protocol; multifocal or multi…
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 for people with triple-negative breast cancer who still had cancer remaining after neoadjuvant chemotherapy — does my situation match that, and would my doctor consider me a candidate worth discussing with the trial team?
2The trial is measuring something called 3-year invasive disease-free survival specifically in 'basal-subtype' patients — can my doctor explain what basal subtype means, and whether my tumor has been tested to know if I fall into that group?
3Since this is a Phase 3 trial using platinum-based chemotherapy, what does my doctor know about the side effect profile of platinum drugs, especially things like kidney function, nerve damage, or hearing changes, that I should weigh before considering this?
4The trial is active but no longer enrolling new patients — does that mean results may be coming soon, and is there any published or preliminary data my doctor can share to help me understand what the treatment showed?
5Given that a standard option like capecitabine already exists for residual triple-negative breast cancer after neoadjuvant chemo, how would my doctor compare that standard path to what this platinum trial is exploring, so I can understand my alternatives?
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
3-year Invasive Disease-Free Survival (IDFS) Rate in Basal-Subtype Patients
Timeframe: No mandatory timeline, assessed at any time as a standard of care procedure or at the investigator's discretion; data reported every 3 months within 2 years from randomization, every 6 months if 2-3 years.