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Randomized Phase II Study of Weekly Irinotecan/Carboplatin (ICb) With or Without Cetuximab (Erbitux) in Patients With Metastatic Breast Cancer (CA225200)
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.
Details
| Lead sponsor | US Oncology Research |
|---|---|
| Phase | Phase 2 |
| Status | ACTIVE_NOT_RECRUITING |
| Enrolment | 154 |
| Start date | 2005-07-28 |
| Completion | 2026-12 |
Conditions
- Metastatic Breast Cancer
Interventions
- Irinotecan + Carboplatin
- irinotecan + Carboplatin + erbitux
Primary outcomes
- Objective Response Rates (ORR) — 2 years
To determine the objective response rates (CR + PR). Complete Response (CR): Disappearance of all target lesions. Partial Response (PR): At least a 30% decrease in the sum of the LD of target lesions taking as reference the baseline sum LD.
Countries
United States