Study on Platinum-Based Chemotherapy for Patients with Residual Triple-Negative Breast Cancer After Initial Treatment
Sponsor: ECOG-ACRIN Cancer Research Group
ClinicalTrials ID:NCT02445391
This clinical trial is comparing the effectiveness of platinum-based chemotherapy drugs (cisplatin or carboplatin) to capecitabine in treating patients with triple-negative breast cancer that remains after initial chemotherapy and surgery.
Patient Parameters
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Program Overview
The purpose of this study is to determine if platinum-based chemotherapy drugs, cisplatin or carboplatin, are more effective than capecitabine in treating patients with triple-negative breast cancer that has not been completely eliminated by initial chemotherapy and surgery. These drugs work by stopping cancer cells from growing, dividing, or spreading. The study will help find out which treatment is better at preventing the cancer from coming back and improving survival rates.
Description
This study aims to compare the effectiveness of two different chemotherapy treatments for patients with triple-negative breast cancer that remains after initial treatment. The main goal is to see which treatment helps patients live longer without the cancer returning. The study will also look at the side effects of each treatment and how they affect patients' quality of life.
Participants will be randomly assigned to one of three groups:
- Group A: Observation only (this group is no longer accepting new participants).
- Group B: Receive cisplatin or carboplatin through an IV every three weeks for four cycles.
- Group C: Take capecitabine pills twice a day for 14 days, repeating every three weeks for up to six cycles.
After completing the treatment, participants will be monitored for up to 10 years to track their health and any recurrence of cancer.
Eligibility Criteria
Inclusion Criteria
- Must be 18 years or older.
- Have a confirmed diagnosis of invasive triple-negative breast cancer.
- Cancer must be at stage II or III at diagnosis, with no spread to other parts of the body.
- Must have completed initial chemotherapy before surgery.
- Must have had surgery to remove the primary tumor.
- Must have residual invasive cancer in the breast after surgery.
- Must have good overall health with an ECOG performance status of 0 or 1.
- Must have adequate blood cell counts and organ function.
- Women of childbearing potential must agree to use effective contraception during the study.
- Must provide a tumor tissue sample for analysis.
Exclusion Criteria
- History of triple-negative breast cancer within the last 5 years.
- Have any other active cancers.
- Have significant infections or other serious medical conditions.
- Women who are pregnant or breastfeeding.
- Have received certain chemotherapy drugs as part of initial treatment.
- Have active neuropathy of grade 2 or higher.
- Have not completed necessary radiation therapy before starting the study treatment.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Mobile Infirmary Medical Center | 36607 | Mobile | Alabama |
| University of South Alabama Mitchell Cancer Institute | 36688 | Mobile | Alabama |
| Anchorage Associates in Radiation Medicine | 98508 | Anchorage | Alaska |
| Anchorage Radiation Therapy Center | 99504 | Anchorage | Alaska |
| Alaska Breast Care and Surgery LLC | 99508 | Anchorage | Alaska |
| Alaska Oncology and Hematology LLC | 99508 | Anchorage | Alaska |
| Alaska Regional Hospital | 99508 | Anchorage | Alaska |
| Alaska Women's Cancer Care | 99508 | Anchorage | Alaska |
| Anchorage Oncology Centre | 99508 | Anchorage | Alaska |
| Katmai Oncology Group | 99508 | Anchorage | Alaska |
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