At a glance
ClinicalIndex Comparison Record- ✓Metastatic (stage IV) breast cancer with measurable disease by RECIST criteria
- ✓ER-negative, PR-negative, and HER-2 nonoverexpressing (IHC 0 or 1, or non-amplified by FISH). HER2 2+ by IHC allowed if FISH confirms non-amplification.
- ✓No more than three prior chemotherapy regimens in adjuvant or metastatic setting
- ✓Prior chemotherapy completed ≥3 weeks before study entry
- ✕Lesions identifiable only by PET scan
- ✕More than 3 prior chemotherapy regimens (including adjuvant)
- ✕Prior EGFR pathway-targeted therapy with therapeutic intent
- ✕Prior platinum agent for metastatic disease. If used adjuvantly, disease-free interval ≥12 months required.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Phase II Trial of Cetuximab Alone and in Combination With Carboplatin in ER-Negative, PR-Negative, HER-2 Nonoverexpressing Metastatic Breast Cancer
In Brief
A Phase 2 clinical trial evaluating cetuximab and carboplatin for Breast Cancer. Completed, enrolled 112 participants across 14 sites.
Detailed Summary
RATIONALE: Monoclonal antibodies, such as cetuximab, 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. Cetuximab may also stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. It is not yet known whether giving cetuximab together with carboplatin is more effective than giving cetuximab alone in treating metastatic breast cancer. PURPOSE: This randomized phase II trial is studying cetuximab and carboplatin to see how well they work compared with cetuximab alone in treating women with estrogen receptor-negative (ER-), progesterone receptor-negative (PR-) metastatic breast cancer.
Study Details
Timeline
Interventions
Given IV
Given IV