Surgical Therapy With or Without Axillary Node Clearance for Breast Cancer in the Elderly Who Receive Adjuvant Therapy With Tamoxifen.
- Compare local and systemic disease-free survival, ipsilateral axillary relapse,
occurrence of postmastectomy syndrome, and overall survival of elderly women with
clinically operable stage I or IIA breast cancer who subsequently receive adjuvant
tamoxifen after treatment with breast surgery with or without axillary node dissection.
- Compare the toxicity of these regimens in these patients.
- Compare the quality of life in patients treated with these regimens.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to
whether they received prior primary surgery (yes vs no) and participating center.
- Arm I: Patients undergo mastectomy, lumpectomy, or quadrantectomy with axillary
clearance. Patients then receive oral tamoxifen for 5 years. Patients may also undergo
sentinel node biopsy.
- Arm II: Patients undergo surgery as in arm I without axillary clearance. Patients then
receive oral tamoxifen for 5 years.
Patients in both arms who undergo breast-conserving surgery may receive optional
radiotherapy for 5-6 weeks to the remaining breast tissue, chest, and lung. Upon recurrence
in the conserved breast, patients undergo total mastectomy; those in arm II who experience
ipsilateral axillary recurrence undergo surgical excision. Adjuvant tamoxifen and follow up
Quality of life is assessed.
Patients are followed every 3 months for 1 year, every 6 months while receiving tamoxifen,
and then annually thereafter.
PROJECTED ACCRUAL: A total of 1,020 patients will be accrued for this study within
approximately 5 years.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Time from randomization to recurrence, metastasis, appearance of a second primary tumor, or death from any cause, whichever occurs first.
17 years from randomization
Diana Crivellari, MD
Centro di Riferimento Oncologico - Aviano
United States: Federal Government