Clinical Trial ECOG-ACRIN 1131
- A Randomized Phase III Post-Operative Trial of Platinum Based Chemotherapy Vs. Capecitabine in Patients with Residual Triple-Negative Basal-Like Breast Cancer following Neoadjuvant Chemotherapy
- Principal Investigator
- Lisa Flaum
- Status: Accepting New Patients
- Study Type: Therapeutic, Treatment
- Protocol No:.ECOG-ACRIN 1131
- The main purpose of this study is to compare the usual approach (i.e. capecitabine), to any good and bad effects of getting more treatment with a platinum-based chemotherapy (using the drug cisplatin or carboplatin), after surgery - in patients with triple negative breast cancer with residual basal-like disease who have received neoadjuvant chemotherapy.
- 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. The use of a platinum-based chemotherapy could prevent the cancer from returning (metastatic recurrence), but it could also cause side effects. This study will allow the researchers to know whether this different approach is better, the same, or worse than the usual approach.
Some of the eligibility criteria include:
- Participants must have early stage breast cancer.
- Participants must have triple negative breast cancer (ER-, PR- and HER2-).
- Participants must be 18 or older.
- Description of Treatment
- Study participants will be randomly assigned by chance (like the flip of a coin) to one of the two study groups. Group 2 will get a platinum-based chemotherapy treatment for 12 weeks. Participants will receive a 30-minute intravenous infusion of either cisplatin or carboplatin once, every 3 weeks, for 4 doses (total of 12 weeks). Group 3 will get capecitabine treatment for 18 weeks. Participants will take the capecitabine pills twice a day for 2 weeks and then get one week off (called a cycle). There will be six cycles. After finishing treatment, all participants will be followed for about 10 years (every 3 months for the first 2 years from study entry, every 6 months if they are 2-5 years from study entry, every 12 months if they are 5-10 years from study entry).
- Clinical Trials Recruitment Nurse
Robert H. Lurie Comprehensive Cancer Center
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last updated: 17-Aug-17 04:43 AM
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