A Randomized, Prospective Trial of 2-6 Weeks Pre-operative Hormonal Treatment for Hormone Receptor Positive Breast Cancer: Anastrozole +/- Fulvestrant or Tamoxifen Exposure - Response in Molecular Profile (AFTER-study).
We will perform a randomized, open-label, single-institution study. It will compare the
efficacy of three different endocrine treatment regimens (Anastrozole +/- Fulvestrant or
Tamoxifen) in changing proliferation-index and inducing apoptosis during a 2-6 week
pre-operative treatment period in breast cancer patients. These results will be correlated
to gene expression profiles, phosphorylation status of the ER, SNPs in CYP450 sequences,
tamoxifen metabolite concentrations, changes in estrogen serum levels and protein expression
Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science
Decrease in tumor cell proliferation and induced apoptosis.
At baseline and after 2-6 weeks of endocrine treatment
Sabine C Linn, MD
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)