Chemotherapy +/− Trastuzumab for Breast Cancer

Recruiting in Palo Alto (17 mi)

Overseen by Joanne Mortimer, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: City of Hope Medical Center

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?

RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. Monoclonal antibodies, such as trastuzumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Giving combination chemotherapy with or without trastuzumab before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. It is not yet known whether combination chemotherapy is more effective with or without trastuzumab in treating breast cancer. PURPOSE: This randomized phase II trial is comparing two different regimens of combination chemotherapy given together with or without trastuzumab to see how well they work in treating patients with stage II or stage III breast cancer.

Research Team

Joanne Mortimer, MD

Principal Investigator

City of Hope Medical Center

Eligibility Criteria

This trial is for adults with stage II or III breast cancer, who have not had chest radiotherapy or other cancers in the past 5 years. They must have good organ function and performance status, no significant neuropathy, and if fertile, agree to use nonhormonal contraception.

Inclusion Criteria

I have inflammatory breast cancer.

Absolute neutrophil count ≥ 1,500/mm^3

Not pregnant or nursing

Exclusion Criteria

I haven't had cancer in the past 5 years, except for certain skin cancers or early-stage cervical cancer.

I had a non-spreading breast cancer diagnosis within the last 5 years.

I haven't taken hormone therapy for conditions other than preventing breast cancer in the last 5 years.

Treatment Details

Interventions

• Carboplatin, Paclitaxel, Docetaxel, Cyclophosphamide, Doxorubicin Hydrochloride (Chemotherapy)
• Trastuzumab (Monoclonal Antibodies)

Trial Overview The study is testing how well combination chemotherapy works with or without trastuzumab (a monoclonal antibody) in shrinking tumors before surgery. Patients are randomly assigned to receive either just chemo or chemo plus trastuzumab.

Participant Groups

Group I: Doxorubicin Hydrochloride and Cyclophosphamide Followed by Paclitaxel, Carboplatin and trastuzumab Experimental Treatment 5 Interventions

Patients receive chemotherapy as in arm II. They also receive trastuzumab (Herceptin®) IV weekly, beginning with the first doses of paclitaxel and carboplatin.

Group II: Doxorubicin Hydrochloride and Cyclophosphamide Followed by Paclitaxel and Carboplatin Experimental Treatment 4 Interventions

Patients receive doxorubicin hydrochloride IV and cyclophosphamide IV on day 1; treatment repeats every 2 weeks for 4 courses. Patients then receive carboplatin IV on day 1 and paclitaxel IV on days 1, 8, and 15; treatment with carboplatin and paclitaxel repeats every 4 weeks for 3 courses.

Group III: Docetaxel, Doxorubicin Hydrochloride, and Cyclophosphamide Active Control 3 Interventions

Patients receive doxorubicin hydrochloride IV, cyclophosphamide IV, and docetaxel IV on day 1. Treatment repeats every 21 days for 6 courses.

Who Is Running the Clinical Trial?

City of Hope Medical Center

Lead Sponsor

Trials

614

Recruited

1,924,000+

Robert Stone

City of Hope Medical Center

Chief Executive Officer since 2014

Juris Doctorate from the University of Chicago, Bachelor's degree in Political Science from the University of Redlands

Sumanta (Monty) Pal

City of Hope Medical Center

Chief Medical Officer since 2023

MD

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