NCT00738777

Pre-operative Hormonal Treatment for Hormone Receptor Positive Breast Cancer

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).

• Status: Suspended
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 250 (estimated)
• Sponsor: The Netherlands Cancer Institute · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
DRUG	Anastrozole	1 mg,QD,PO
DRUG	Anastrozole+Fulvestrant	Anastrozole; 1 mg, QD, PO Fulvestrant; 500 mg, IM, day 1, 15, 29 and monthly thereafter
DRUG	Tamoxifen	loading dose of 40 mg, TID, PO, during 7 days, Thereafter 20 mg, QD, PO
DRUG	Tamoxifen	loading dose of 40 mg, TID, PO, during 7 days, Thereafter 20 mg, QD, PO

Timeline

• Start date: 2008-07-01
• Primary completion: 2022-06-01
• Completion: 2024-06-01
• First posted: 2008-08-20
• Last updated: 2021-01-22

Locations

4 sites across 1 country: Netherlands