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Protocol No. EA1131

Principal Investigator Tevaarwerk, Amye

Phase III

Age Group Adult

Scope National

Sponsor Type National

Title A Randomized Phase III Post-Operative Trial of Platinum Based Chemotherapy VS Capecitabine in Patients with Residual Triple-Negative Breast Cancer following Neoaduvant Chemotherapy

Objective The main purpose of this study is to compare getting more treatment with capecitabine (i.e. one of the usual approaches), to any good and bad effects of getting more treatment with a platinum-based chemotherapy (cisplatin or carboplatin), after surgery.

Treatment Platinum agents (cisplatin or carboplatin) are already FDA-approved to be used in patients with stage IV breast cancers, but are usually not used in patients with early forms of breast cancer. Getting a platinum-based chemotherapy after surgery could prevent the cancer from returning (metastatic recurrence). This study will allow the researchers to know whether this different approach is better, the same, or worse than using capecitabine chemotherapy.

Description This study currently has two active study groups. A computer will by chance assign you to treatment groups in the study. This is called randomization. If you get randomized to the platinum-based chemotherapy group (Group 2), you will receive an intravenous infusion (IV through the vein) of either cisplatin or carboplatin once, every 3 weeks, for 4 doses (total of 12 weeks). If you get randomized to the usual approach group (Group 3), you will receive capecitabine pills for a total of 6 cycles (total of 18 weeks). Each cycle is 3 weeks long. In these cycles you will take the pills twice a day for 2 weeks and then get one week off.

Key Eligibility
  • Female and male patients must have histologically confirmed invasive breast cancer that is clinical stage II or III and ER- and PR-, HER2 negative
  • No metastatic disease allowed
  • Patients must have completed neoadjuvant taxane +/- anthracycline
  • Patients must NOT have received cisplatin or carboplatin or capecitabine as part of their neoadjuvant therapy regimen
  • Must have completed definitive resection of primary tumor
  • Age ≥ 18 years
  • Radiotherapy may be given before or after protocol treatment per standard of care guidelines
  • Adjuvant chemotherapy after surgery other than that specified in this protocol is not allowed. LHRH agonists and adjuvant bisphosphonate or denosumab use is allowed
  • Women must not be pregnant or breast-feeding
  • Post neoadjuvant chemotherapy, patients must be found to have residual invasive cancer measuring ≥ 1 cm in diameter in the breast at the time of definitive surgery

Applicable Disease Sites Breast

Drugs Involved Capecitabine; Xeloda (Capecitabine); carboplatin; cbdca (carboplatin); cis-diamminedichloroplatinum (cisplatin); cisplatin; paraplatin (carboplatin); platinol (cisplatin); platinum (cisplatin)

Status Open

Participating Institutions Dean Health System, Hematology and Oncology Clinic ; Johnson Creek, UW Cancer Center; Swedish American Hospital, Rockford ; UW Hospital and Clinics; UWCCC 1 South Park