Platinum Chemotherapy for Triple-Negative Breast Cancer

Recruiting at1023 trial locations

Overseen by Ingrid Mayer

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: ECOG-ACRIN Cancer Research Group

Stay on Your Current Meds

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?

This randomized phase III trial studies how well cisplatin or carboplatin (platinum based chemotherapy) works compared to capecitabine in treating patients with remaining (residual) basal-like triple-negative breast cancer following chemotherapy after surgery (neoadjuvant). Drugs used in chemotherapy, such as cisplatin, carboplatin and capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. It is not yet known whether cisplatin or carboplatin is more effective than capecitabine in treating patients with residual triple negative basal-like breast cancer.

Research Team

Ingrid Mayer

Principal Investigator

ECOG-ACRIN Cancer Research Group

Eligibility Criteria

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

I can receive radiotherapy before or after the trial treatment as per standard guidelines.

I completed a specific chemotherapy regimen without cisplatin, carboplatin, or capecitabine.

I have not received any chemotherapy after surgery that is not listed in this study.

Exclusion Criteria

I had triple-negative breast cancer within the last 5 years and no other cancers.

I do not have any serious infections.

Treatment Details

Interventions

• Carboplatin (Platinum-based Chemotherapy)
• Cisplatin (Platinum-based Chemotherapy)

Trial Overview The study compares the effectiveness of platinum-based chemotherapy (cisplatin or carboplatin) versus capecitabine in patients with residual basal-like triple-negative breast cancer post-surgery. It aims to determine which treatment better stops tumor growth by killing cells or preventing their spread.

Participant Groups

Group I: Arm B (cisplatin or carboplatin) Experimental Treatment 2 Interventions

Patients receive cisplatin IV or carboplatin IV on day 1. Treatment repeats every 3 weeks for 4 courses in the absence of disease progression or unacceptable toxicity.

Group II: Arm A (observation) (closed to accrual 05/16/2016) Active Control 1 Intervention

Patients undergo observation.

Group III: Arm C (capecitabine) Active Control 1 Intervention

Patients receive capecitabine PO BID on days 1-14. Treatment repeats every 3 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.

Carboplatin is already approved in Canada for the following indications:

Approved in Canada as Carboplatin for:

• Ovarian cancer
• Small cell lung cancer
• Testicular cancer

Who Is Running the Clinical Trial?

ECOG-ACRIN Cancer Research Group

Lead Sponsor

Trials

122

Recruited

160,000+

Dr. Peter J. O'Dwyer

ECOG-ACRIN Cancer Research Group

Chief Executive Officer since 2012

MD from University of Pennsylvania

Dr. Mitchell D. Schnall

ECOG-ACRIN Cancer Research Group

Chief Medical Officer since 2012

MD, PhD from University of Pennsylvania

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Dr. Douglas R. Lowy

National Cancer Institute (NCI)

Chief Executive Officer since 2023

MD from New York University School of Medicine

Dr. Monica Bertagnolli

National Cancer Institute (NCI)

Chief Medical Officer since 2022

MD from Harvard Medical School