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Alkylating agents

Chemotherapy +/- Erbitux for Breast Cancer (CA225200 Trial)

Phase 2

Waitlist Available

Led By Joyce A. O'Shaughnessy, MD

Research Sponsored by US Oncology Research

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Has cytologically or pathologically confirmed breast cancer with documented HER2+ (positive) or HER2- (negative) disease

Has had up to 1 prior chemotherapy regimens for metastatic disease

Must not have

Has received prior treatment with irinotecan, carboplatin, or cisplatin

Has received prior therapy which specifically and directly targets the EGFR pathway. Prior Herceptin is required for HER2+ patients

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a combination of drugs to treat metastatic breast cancer, with or without the drug Erbitux.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects include reactions related to infusion, gastrointestinal issues like diarrhea from irinotecan, low blood counts due to carboplatin, and skin reactions that might be caused by Erbitux.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My breast cancer is confirmed and tested for HER2 status.

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I have had one chemotherapy treatment for my advanced cancer.

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

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My breast cancer can be measured by standard health tests.

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I am able to get out of my bed or chair and move around.

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I am over 18 years old.

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I have breast cancer tissue samples available for testing.

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I have received Herceptin for my HER2+ breast cancer.

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My breast cancer has spread to other parts of my body.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

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

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

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I have brain metastases that are causing symptoms or haven't been treated.

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I am currently taking a tyrosine kinase inhibitor medication.

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I have heart disease that is not well-controlled or had a heart attack in the last year.

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I have acute hepatitis or am HIV positive.

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I have had another type of cancer in the last 5 years that could interfere with my breast cancer diagnosis.

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I finished chemotherapy less than 3 weeks ago.

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I had major surgery less than 3 weeks ago and haven't fully recovered.

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I have not taken any cancer immunotherapy or hormone therapy in the last 2 weeks.

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I have had a stem cell or bone marrow transplant for blood cancer.

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I have an ongoing or untreated infection.

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I have significant nerve pain or tingling in my hands or feet.

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I have received an organ transplant that is not corneal, bone, or skin.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Objective Response Rates (ORR)

Secondary study objectives

Duration of Response

Median Overall Survival (OS)

Median Time of Progression-free Survival (PFS)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Arm 2Experimental Treatment1 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 1Active Control1 Intervention

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

0 / 24Eligibility criteria met