Phase I/II Study of Bendamustine and Erlotinib for Metastatic or Locally Advanced Triple Negative Breast Cancer
- To determine the phase II dose and assess the toxicity of bendamustine hydrochloride
and erlotinib hydrochloride in patients with triple-receptor (estrogen receptor,
progesterone receptor, and HER-2)-negative, stage IIIB, IIIC, or IV breast cancer.
- To determine the efficacy of this regimen in these patients. (Phase II)
- To assess the correlation between tumor EGFR expression and EGFR gene amplification and
treatment efficacy and toxicity.
- To assess for differences in treatment efficacy between basal-like and non-basal-like
- To assess for differences in treatment efficacy between tumors with and without
expression of DNA damage-response (DDR) checkpoint proteins.
- To assess for differences in the activation state of DDR checkpoint proteins based on
breast cancer subtype.
OUTLINE: This is a multicenter, phase I dose-escalation study followed by a phase II study.
Patients receive bendamustine hydrochloride IV over 30 minutes on days 1-2 and oral
erlotinib hydrochloride once daily on days 5-21. Treatment repeats every 28 days for at
least 6 courses in the absence of disease progression or unacceptable toxicity.
Patients with no evidence of disease progression may continue with daily single-agent oral
erlotinib hydrochloride on days 1-28. Treatment continues every 28 days in the absence of
disease progression or unacceptable toxicity.
Breast cancer tissue blocks from prior procedures are obtained for correlative studies.
After a tissue microarray (TMA) and a TMA map are prepared, TMA slides are used for
hematoxylin and eosin (H&E) staining, FISH, and IHC.
After completion of study treatment, patients are followed every 3 months for 2 years.
Masking: Open Label, Primary Purpose: Treatment
Maximum-tolerated dose of bendamustine hydrochloride and erlotinib hydrochloride (phase I)
Rachel Layman, MD
Ohio State University Comprehensive Cancer Center
United States: Federal Government
|University of Michigan Comprehensive Cancer Center||Ann Arbor, Michigan 48109-0752|
|Robert H. Lurie Comprehensive Cancer Center at Northwestern University||Chicago, Illinois 60611|
|Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at Ohio State University Comprehensive Cancer Center||Columbus, Ohio 43210-1240|