Chemotherapy Combinations for Triple-Negative Breast Cancer

Recruiting at1295 trial locations

Overseen by Vicente Valero

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: NRG Oncology

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 doxorubicin hydrochloride and cyclophosphamide followed by paclitaxel with or without carboplatin work in treating patients with triple-negative breast cancer. Drugs used in chemotherapy, such as doxorubicin hydrochloride, cyclophosphamide, paclitaxel, and carboplatin, 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 doxorubicin hydrochloride and cyclophosphamide is more effective when followed by paclitaxel alone or paclitaxel and carboplatin in treating triple-negative breast cancer.

Research Team

Vicente Valero

Principal Investigator

NRG Oncology

Eligibility Criteria

This trial is for patients with triple-negative breast cancer who have good blood counts, no metastatic disease on imaging, and a performance status indicating they can care for themselves. They must not be pregnant or breastfeeding, haven't received certain cancer treatments before, and don't have other serious health issues that would interfere with the study.

Inclusion Criteria

My breast cancer has spread to nearby lymph nodes but not to distant parts of my body.

I have had a mastectomy or lumpectomy.

My kidneys are working well.

Exclusion Criteria

You have mental health or addiction issues that may interfere with the study requirements.

I have a lung condition that makes it hard for me to breathe.

My breast cancer is advanced (T4) or inflammatory.

Treatment Details

Interventions

• Carboplatin (Anti-metabolites)
• Cyclophosphamide (Alkylating agents)
• Doxorubicin Hydrochloride (Alkylating agents)
• Paclitaxel (Anti-metabolites)

Trial Overview The trial is testing if adding carboplatin to a chemotherapy regimen of doxorubicin hydrochloride and cyclophosphamide followed by paclitaxel improves outcomes in treating triple-negative breast cancer compared to the regimen without carboplatin.

Participant Groups

Group I: Arm II (AC-->WP + carboplatin) Experimental Treatment 5 Interventions

Patients receive doxorubicin hydrochloride and cyclophosphamide as in Arm I. Patients then receive paclitaxel IV over 60 minutes on days 1, 8, and 15 and carboplatin IV over 30-60 minutes on day 1. Treatment repeats every 3 weeks for 4 courses in the absence of disease progression or unacceptable toxicity.

Group II: Arm I (AC-->WP) Active Control 4 Interventions

Patients receive doxorubicin hydrochloride IV over 15 minutes and cyclophosphamide IV over 30 minutes on day 1. Treatment repeats every 2 weeks for 4 courses in the absence of disease progression or unacceptable toxicity. Patients then receive paclitaxel IV over 60 minutes on day 1. Treatment repeats weekly for 12 courses in the absence of disease progression or unacceptable toxicity.

Cyclophosphamide is already approved in Canada, Japan for the following indications:

Approved in Canada as Neosar for:

• Breast cancer
• Ovarian cancer
• Multiple myeloma
• Leukemia
• Lymphoma
• Rheumatoid arthritis

Approved in Japan as Endoxan for:

• Breast cancer
• Ovarian cancer
• Multiple myeloma
• Leukemia
• Lymphoma

Who Is Running the Clinical Trial?

NRG Oncology

Lead Sponsor

Trials

242

Recruited

105,000+

Stephanie Gaillard

NRG Oncology

Chief Medical Officer

MD from Johns Hopkins University

Norman Wolmark

NRG Oncology

Chief Executive Officer since 2023

MD from Harvard Medical School

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