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

• Status: Completed
• Trial end date: 2010-10-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Institut du Cancer de Montpellier - Val d'Aurelle
• Treatments: Citric Acid; Letrozole; Tamoxifen

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