Response to Neoadjuvant Treatment With Anti-aromatase Anastrozole and Anti-estrogen Fulvestrant: a Randomized Phase II Study in Postmenopausal Patients With Hormone-sensitive Nonmetastatic Breast Cancer and an Exploratory Study of Molecular Signatures of Response
- Evaluate clinical tumor response at 6 months in patients with hormone-sensitive
nonmetastatic breast cancer treated with neoadjuvant anastrozole vs fulvestrant.
- Evaluate tumor regression by mammography and ultrasound in these patients.
- Evaluate the rate of breast conservation at 6 months of treatment in these patients.
- Evaluate the tolerability of these regimens.
- Estimate the progression-free survival at 5 years of these patients.
- Identify molecular signatures predictive of response in these patients.
- Identify genes implicated in response in these patients.
- Identify changes in mRNA splicing of genes involved in breast tumorigenesis.
OUTLINE: This is a multicenter study.
All patients undergo biopsy at baseline. Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive oral anastrozole once daily for 6 months.
- Arm II: Patients receive fulvestrant intramuscularly on days 1, 14, and 28 and then
once a month at 2-6 months.
Within 8 days after completion of hormone therapy, all patients undergo surgical resection
of the residual lesion followed by radiotherapy. Patients then receive oral anastrozole once
daily for 5 years.
Tissue samples from biopsy and surgery are analyzed to assess molecular signatures and
sensitivity to treatment, and to compare gene expression variation with response.
Allocation: Randomized, Masking: Open Label, Primary Purpose: Treatment
Tumor response at 6 months of treatment according to RECIST criteria
Louis Mauriac, MD