Breast Cancer
Conditions
Keywords
estrogen receptor-positive breast cancer, stage IA breast cancer, stage IB breast cancer, stage II breast cancer, stage IIIA breast cancer
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.
Interventions
DRUGletrozole
Given orally
DRUGtamoxifen citrate
Given orally
Sponsors
Institut du Cancer de Montpellier - Val d'Aurelle
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
65 Years to 120 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes in Ki67 and PCNA after 4 months of treatment with letrozole vs tamoxifen citrate | up to 24 months |
Secondary
| Measure | Time frame |
|---|---|
| Molecular signature predictive of sensitivity or resistance to estrogen receptor-positive breast adenocarcinoma | up to 24 months |
| Survival rate | up to 24 months |
Countries
France
Outcome results
None listed