Status:
COMPLETED
Letrozole or Tamoxifen Citrate in Treating Older Postmenopausal Women Undergoing Surgery for Breast Cancer
Lead Sponsor:
Institut du Cancer de Montpellier - Val d'Aurelle
Conditions:
Breast Cancer
Eligibility:
FEMALE
65-120 years
Phase:
PHASE3
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 b...
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 cit...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
December 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2010
Estimated Enrollment :
177 Patients enrolled
Trial Details
Trial ID
NCT00949598
Start Date
December 1 2008
End Date
October 1 2010
Last Update
February 13 2025
Active Locations (1)
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1
Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle
Montpellier, France, 34298