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 States415 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 range18 Years
SexALL
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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…
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.