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Title:
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
Protocol Number:
NCTNEA1131
Phase:
Phase III
Physician:
Roisin Connolly
Sites:
Johns Hopkins Kimmel Cancer Center in Baltimore
Sibley Memorial Hospital
Purpose:
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.
Eligibility:
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.
Treatment:
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).
Population:
Adult
Last Update
03/05/2019 05:03 AM