NCT00949598

Letrozole or Tamoxifen Citrate in Treating Older Postmenopausal Women Undergoing Surgery for Breast Cancer

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.

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 177 (actual)
• Sponsor: Institut du Cancer de Montpellier - Val d'Aurelle · Academic / Other
• Sex: Female
• Age: 65 Years – 120 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

OBJECTIVES: Primary * 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. Secondary * 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.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
DRUG	letrozole	Given orally
DRUG	tamoxifen citrate	Given orally

Timeline

• Start date: 2008-12-01
• Primary completion: 2010-10-01
• Completion: 2010-10-01
• First posted: 2009-07-30
• Last updated: 2025-02-13

Locations

1 site across 1 country: France