At a glance
ClinicalIndex Comparison Record- ✓Histologically confirmed unresectable stage IIIB or IIIC breast cancer, OR stage IV breast cancer
- ✓Triple-negative: estrogen receptor <10%, progesterone receptor <10%, and HER2 negative (negative FISH, IHC 0–1+, or IHC 2+ with negative FISH)
- ✓Measurable or evaluable disease
- ✓ECOG performance status 0–2
- ✕Symptomatic or progressive CNS metastases (unless previously treated ≥8 weeks prior, no concurrent steroids, and no leptomeningeal disease)
- ✕Prior bendamustine or EGFR-directed therapy
- ✕Uncontrolled intercurrent illness or active infection requiring systemic therapy
- ✕Unable to swallow oral medications or medical conditions affecting GI absorption (uncontrolled nausea/vomiting/diarrhea, lack of upper GI tract integrity, malabsorption syndrome)
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Phase I/II Study of Bendamustine and Erlotinib for Metastatic or Locally Advanced Triple Negative Breast Cancer
In Brief
A Phase 2 clinical trial evaluating bendamustine, erlotinib, and 1 other intervention for Breast Cancer. Completed, enrolled 11 participants across 1 site.
Detailed Summary
RATIONALE: Drugs used in chemotherapy, such as bendamustine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Erlotinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. Giving bendamustine together with erlotinib may kill more tumor cells. PURPOSE: This phase I/II trial is studying the side effects and best dose of giving bendamustine together with erlotinib in treating patients with stage IIIB, stage IIIC, or stage IV breast cancer.
Study Details
Timeline
Interventions
100 or 120 mg/m2 IV on days 1 and 2
100 or 150 mg po on days 5 - 21 of each 28 day cycle
150 mg po daily (days 1 - 28 of 28 day cycle)