Platinum Chemotherapy for Triple-Negative Breast Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to determine whether the chemotherapy drugs cisplatin or carboplatin (both platinum-based) are more effective than capecitabine in treating triple-negative basal-like breast cancer that persists after initial chemotherapy and surgery. The trial will assess if these drugs can more effectively stop cancer cells from growing or spreading. Suitable participants are those who have undergone chemotherapy and surgery for stage II or III triple-negative breast cancer but still have residual cancer in the breast. As a Phase 3 trial, this study represents the final step before FDA approval, providing participants access to potentially effective treatments.
Will I have to stop taking my current medications?
The trial protocol does not specify whether you need to stop taking your current medications. However, adjuvant chemotherapy other than specified in the protocol is not allowed, but certain medications like LHRH agonists and bisphosphonates are permitted. It's best to discuss your current medications with the trial team.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research shows that both carboplatin and cisplatin have undergone safety studies for treating triple-negative breast cancer. Studies indicate that carboplatin is generally well-tolerated, with manageable side effects like low blood counts, nausea, or fatigue. A review of various studies shows that cisplatin is also considered safe, with common side effects similar to those of carboplatin. Both treatments have been safely used in clinical settings for cancer.
These treatments have also been applied to other cancer types, further supporting their safety. Prospective trial participants can find reassurance in the thorough safety studies of these drugs. Always consult a doctor to understand how these treatments might affect you personally.12345Why are researchers excited about this trial's treatments?
Researchers are excited about platinum-based chemotherapy, using Carboplatin and Cisplatin, for triple-negative breast cancer because these drugs offer a unique approach to attacking cancer cells. Unlike standard treatments such as anthracyclines and taxanes, Carboplatin and Cisplatin work by binding to the DNA of cancer cells, causing damage that prevents them from multiplying. This mechanism can be particularly effective for triple-negative breast cancer, which lacks the hormone receptors that many other treatments target. Additionally, these drugs can be administered intravenously, allowing for precise dosing and potentially reducing side effects compared to oral treatments. The potential for more targeted action and the ability to tackle aggressive cancer cells makes this approach a promising alternative to existing therapies.
What evidence suggests that this trial's treatments could be effective for triple-negative breast cancer?
Research has shown that platinum-based chemotherapy, such as carboplatin, holds promise for treating triple-negative breast cancer. In this trial, some participants will receive carboplatin. Studies have found that it can help patients with early-stage triple-negative breast cancer live longer and reduce the chance of recurrence. After three years, 77.9% of patients using carboplatin experienced no cancer return, and 87.6% remained alive.
Other participants in this trial will receive cisplatin. Studies suggest that cisplatin has strong effects against tumors and can improve outcomes for patients with residual tumors after initial treatment. Cisplatin has maintained its effectiveness, potentially leading to better chances of staying cancer-free in triple-negative breast cancer. Both treatments show potential, but it remains unclear which one might be more effective for this specific condition.678910Who Is on the Research Team?
Ingrid Mayer
Principal Investigator
ECOG-ACRIN Cancer Research Group
Are You a Good Fit for This Trial?
This trial is for adults with triple-negative breast cancer that remains after initial chemotherapy and surgery. Participants must have completed neoadjuvant taxane +/- anthracycline therapy, not received cisplatin, carboplatin, or capecitabine as part of this regimen, and meet certain health criteria like specific blood cell counts and liver function.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive either cisplatin or carboplatin intravenously every 3 weeks for 4 courses, or capecitabine orally twice daily for up to 6 courses
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Carboplatin
- Cisplatin
Carboplatin is already approved in United States, European Union, Canada for the following indications:
- Ovarian cancer
- Testicular cancer
- Lung cancer
- Head and neck cancer
- Brain cancer
- Ovarian cancer
- Small cell lung cancer
- Ovarian cancer
- Small cell lung cancer
- Testicular cancer
Find a Clinic Near You
Who Is Running the Clinical Trial?
ECOG-ACRIN Cancer Research Group
Lead Sponsor
National Cancer Institute (NCI)
Collaborator