Letrozole or Tamoxifen Citrate in Treating Older Postmenopausal Women Undergoing Surgery for Breast Cancer
RATIONALE: Estrogen can cause the growth of breast cancer cells. Hormone therapy using letrozole may fight breast cancer by blocking the uptake of estrogen. Tamoxifen citrate may fight breast cancer by blocking the use of estrogen by the tumor cells. It is not yet known whether letrozole or tamoxifen citrate is more effective when given before surgery in treating older women with breast cancer.
PURPOSE: This randomized phase III trial is studying letrozole to see how well it works compared with tamoxifen citrate in treating older postmenopausal women undergoing surgery for breast cancer.
|Study Design:||Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
|Official Title:||Randomized Double-blind Study to Compare Two Neo-adjuvant Treatments: an Anti-aromatase vs SERM for Postmenopausal Women With ER+ Breast Adenocarcinoma: Effect on Intermediate Predictive Biological Response to Treatment.|
- Changes in Ki67 and PCNA after 4 months of treatment with letrozole vs tamoxifen citrate [ Time Frame: up to 24 months ] [ Designated as safety issue: No ]
- Molecular signature predictive of sensitivity or resistance to estrogen receptor-positive breast adenocarcinoma [ Time Frame: up to 24 months ] [ Designated as safety issue: No ]
- Survival rate [ Time Frame: up to 24 months ] [ Designated as safety issue: No ]
|Study Start Date:||December 2008|
|Study Completion Date:||October 2010|
|Primary Completion Date:||October 2010 (Final data collection date for primary outcome measure)|
Experimental: Arm I
Patients receive oral letrozole once daily for 16 weeks.
Experimental: Arm II
Patients receive oral tamoxifen citrate once daily for 16 weeks.
Drug: tamoxifen citrate
- 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 tamoxifen citrate.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00949598
|Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle|
|Montpellier, France, 34298|
|Principal Investigator:||Philippe Rouanet, MD, PhD||Institut du Cancer de Montpellier - Val d'Aurelle|