Breast Cancer Clinical Trial
Official title:
Surgical Therapy With or Without Axillary Node Clearance for Breast Cancer in the Elderly Who Receive Adjuvant Therapy With Tamoxifen.
RATIONALE: Removing axillary lymph nodes may be effective in stopping the spread of breast
cancer cells. It is not yet known if surgery to remove breast cancer is more effective with
or without lymph node removal.
PURPOSE: Randomized phase III trial to compare the effectiveness of breast surgery with or
without removal of axillary lymph nodes in treating women who have stage I or stage IIA
breast cancer.
OBJECTIVES:
- 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
are continued.
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
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