Chemotherapy +/- Erbitux for Breast Cancer

(CA225200 Trial)

Recruiting in Palo Alto (17 mi)

+57 other locations

Overseen by Joyce A. O'Shaughnessy, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: US Oncology Research

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?

The purpose of this study is to determine the objective response rates produced by irinotecan and carboplatin therapy with or without Erbitux in patients with Metastatic Breast Cancer.

Research Team

Joyce A. O'Shaughnessy, MD

Principal Investigator

US Oncology Research

Eligibility Criteria

This trial is for adults with Stage IV metastatic breast cancer who've had up to one prior chemo regimen and no past treatment with irinotecan, carboplatin, or cisplatin. They must have measurable disease per RECIST Criteria and provide tissue samples. HER2 status needs documentation, and those with HER2+ must have had Herceptin therapy.

Inclusion Criteria

My breast cancer is confirmed and tested for HER2 status.

I have had one chemotherapy treatment for my advanced cancer.

I have not been treated with irinotecan, carboplatin, or cisplatin.

Exclusion Criteria

I have been treated with irinotecan, carboplatin, or cisplatin before.

I have been treated with drugs targeting EGFR. I've had Herceptin if my cancer is HER2+.

I have early or nonmeasurable metastatic breast cancer, or a different condition than specified in the first criterion.

Treatment Details

Interventions

• Carboplatin (Alkylating agents)
• Erbitux (Monoclonal Antibodies)
• Irinotecan (Alkylating agents)

Trial Overview The study aims to compare the effectiveness of two chemotherapy combinations in treating metastatic breast cancer: irinotecan + carboplatin + erbitux versus irinotecan + carboplatin alone. The main goal is to see how well tumors respond to these treatments.

Participant Groups

Group I: Arm 2 Experimental Treatment 1 Intervention

irinotecan 90mg/m2, carboplatin AUC=2.0 on Days 1 and 8 of each 21- day cycle plus Erbitux 400 mg/m2 Week 1 and then 250 mg/m2 weekly thereafter, (Arm 2, ICb+Erbitux)

Group II: Arm 1 Active Control 1 Intervention

irinotecan 90 mg/m2 and carboplatin AUC=2.0 on Days 1 and 8 of each 21-day cycle (Arm 1, ICb)

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?

US Oncology Research

Lead Sponsor

Trials

38

Recruited

17,400+

Pfizer

Industry Sponsor

Trials

4,712

Recruited

50,980,000+

Known For

Vaccine Innovations

Top Products

Viagra, Zoloft, Lipitor, Prevnar 13

Albert Bourla

Pfizer

Chief Executive Officer since 2019

PhD in Biotechnology of Reproduction, Aristotle University of Thessaloniki

Patrizia Cavazzoni

Pfizer

Chief Medical Officer

MD from McGill University

Bristol-Myers Squibb

Industry Sponsor

Trials

2,731

Recruited

4,127,000+

Headquarters

New York City, USA

Known For

Oncology & Cardiovascular

Top Products

Eliquis, Opdivo, Revlimid, Orencia

Christopher Boerner

Bristol-Myers Squibb

Chief Executive Officer since 2023

PhD in Business Administration from the Haas School of Business, University of California, Berkeley; BA in Economics and History from Washington University in St. Louis

Deepak L. Bhatt

Bristol-Myers Squibb

Chief Medical Officer since 2024

MD from Yale University; MSc in Clinical Epidemiology from the University of Pennsylvania