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Brief Title: Pre-operative Hormonal Treatment for Hormone Receptor Positive Breast Cancer
Official Title: 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).
Study ID: NCT00738777
Brief Summary: To investigate prospectively whether short term endocrine treatment can induce molecular changes, predictive for therapy response.
Detailed Description: 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 patterns.
Minimum Age:
Eligible Ages: CHILD, ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Medisch Centrum Haaglanden, den Haag, ZH, Netherlands
NKI-AVL, Amsterdam, , Netherlands
St. Antonius ziekenhuis, Nieuwegein, , Netherlands
UMC St. Radboud, Nijmegen, , Netherlands
Name: Sabine C Linn, MD
Affiliation: NKI-AvL
Role: PRINCIPAL_INVESTIGATOR