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

Phase 3

Completed

• Conditions: Breast Cancer
• Interventions: Drug: tamoxifen citrate; Drug: letrozole

• Registration Number: NCT00949598
• Lead Sponsor: Institut du Cancer de Montpellier - Val d'Aurelle

Brief 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.

Study Timeline

• Study Start: 2008-12
• Study First Submitted: 2009-07-29
• Study First Submitted QC: 2009-07-29
• Study First Posted: 2009-07-30
• Primary Completion: 2010-10
• Study Completion: 2010-10
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-11
• Last Update Posted: 2025-02-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 177

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm II	tamoxifen citrate	Patients receive oral tamoxifen citrate once daily for 16 weeks.
Arm I	letrozole	Patients receive oral letrozole once daily for 16 weeks.

Primary Outcome Measures

Name	Time	Method
Changes in Ki67 and PCNA after 4 months of treatment with letrozole vs tamoxifen citrate	up to 24 months

Secondary Outcome Measures

Name	Time	Method
Molecular signature predictive of sensitivity or resistance to estrogen receptor-positive breast adenocarcinoma	up to 24 months
Survival rate	up to 24 months

Trial Locations

Locations (1)

Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle; 🇫🇷 Montpellier, France