Randomized Double-blind Study to Compare Two Neo-adjuvant Treatments: an Anti-aromatase (Letrozole) vs a SERM (Tamoxifen) for Postmenopausal Women With ER+ Breast Adenocarcinoma: Effect on Intermediate Predictive Biological Response to Treatment.
- Investigate the changes in Ki67 and PCNA in postmenopausal women with estrogen
receptor-positive (ER+) breast cancer after 4 months of treatment with letrozole vs
- Compare the response after 4 months of therapy.
- Define the resistant forms of cancer in patients treated with these regimens.
- Define the molecular signature predictive of sensitivity or resistance to ER+ breast
adenocarcinoma by gene and serum protein profiling.
- Search for serum protein profiles predictive of recurrence-free interval.
OUTLINE: Patients are randomized into 1 of 2 intervention arms.
- Arm I: Patients receive oral letrozole once daily for 16 weeks.
- Arm II: Patients receive oral tamoxifen citrate once daily for 16 weeks. Patients in
both arms then undergo surgery.
Blood and tumor tissue samples are collected at baseline and after completion of neoadjuvant
therapy for changes in Ki67 and PCNA and serum protein profiling analysis.
After completion of study therapy, patients are followed up every 6 months for 3 years, and
then once a year for 5 years.
Allocation: Randomized, Masking: Double-Blind, Primary Purpose: Treatment
Changes in Ki67 and PCNA after 4 months of treatment with letrozole vs tamoxifen citrate
Philippe Rouanet, MD, PhD
Centre Val d'Aurelle - Paul Lamarque