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

NCT ID: NCT00949598

Last Updated: 2025-02-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 177 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-12-31
• Study Completion Date: 2010-10-31

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.

Conditions

Breast Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Arm I

Patients receive oral letrozole once daily for 16 weeks.

Group Type: EXPERIMENTAL

letrozole

Intervention Type: DRUG

Given orally

Arm II

Patients receive oral tamoxifen citrate once daily for 16 weeks.

Group Type: EXPERIMENTAL

tamoxifen citrate

Intervention Type: DRUG

Given orally

Interventions

letrozole

Given orally

Intervention Type: DRUG

tamoxifen citrate

Given orally

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed invasive breast adenocarcinoma

• Clinically T2 tumor and/or > 1 cm by echography
• Estrogen receptor (ER)-positive and > 10% of the tumor cells positive

• No ER-negative disease
• No prior breast cancer
• No metastatic or inflammatory breast adenocarcinoma

PATIENT CHARACTERISTICS:

• Postmenopausal
• No cardiac function that could contraindicate surgery or medical treatment (e.g., radiotherapy and/or chemotherapy)
• No prior malignancies within the past 5 years except for nonmelanoma skin cancer or carcinoma in situ of the cervix
• No mental incapacitation that would preclude consent
• No contraindication to tamoxifen citrate or letrozole

PRIOR CONCURRENT THERAPY:

• More than 8 days since prior hormone-replacement therapy or other treatment (i.e., phytoestrogen) for menopause
• No concurrent therapy that would modify the expression of the genes regulated by estrogen
• No concurrent participation in another clinical study

• Minimum Eligible Age: 65 Years
• Maximum Eligible Age: 120 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Institut du Cancer de Montpellier - Val d'Aurelle

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Philippe Rouanet, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Institut du Cancer de Montpellier - Val d'Aurelle

Locations

Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle

Montpellier, , France

Countries

France

Other Identifiers

CDR0000638373

Identifier Type: -

Identifier Source: org_study_id