EA1131 A Randomized Phase III Post-Operative Trial of Platinum Based Chemotherapy versus Capecitabine in Patients with Residual Triple-Negative Basal-Like Breast Cancer following Neoadjuvant Chemotherapy
Johns Hopkins Kimmel Cancer Center in Baltimore
Sibley Memorial Hospital
The main purpose of this study is to compare the usual approach (i.e. no more treatment), to any good and bad effects of getting more treatment with a platinum-based chemotherapy (cisplatin or carboplatin), after surgery.
You may be eligible if you have the following:* Breast cancer that does not have the estrogen, progesterone or HER2 receptor, and is called triple-negative breast cancer,* Completed all your chemotherapy prior to your surgery, * equal to 1 cm worth of cancer in the breast at the time of your surgery, and* Completed your radiation treatment after surgery, if indicated.
This study has two study groups:* Group 1 will get the usual approach used for this type of cancer: observation. * Group 2 will get a platinum-based chemotherapy treatment for 3 months. You and your doctor will get to choose between cisplatin or carboplatin.If you get randomized to the platinum-based chemotherapy group (Group 2), you will receive a 30-minute intravenous infusion of either cisplatin or carboplatin once, every 3 weeks, for 4 doses (total of 3 months). After you finish the platinum-based chemotherapy, your doctor will continue to watch you for side effects and follow your condition for about 10 years (every 3 months if you are less than 2 years from study entry, every 6 months if you are 2-5 years from study entry, every 12 months if you are 5-10 years from study entry).If you get randomized to the usual approach group (Group 1), your doctor will follow your condition for about 10 years (every 3 months if you are less than 2 years from study entry, every 6 months if you are 2-5 years from study entry, every 12 months if you are 5-10 years from study entry).
03/05/2019 05:03 AM