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Brief Title: Surgery With or Without Lymph Node Removal in Treating Older Women With Stage I or Stage IIA Breast Cancer
Official Title: Surgical Therapy With or Without Axillary Node Clearance for Breast Cancer in the Elderly Who Receive Adjuvant Therapy With Tamoxifen.
Study ID: NCT00002528
Brief Summary: 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.
Detailed Description: 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.
Minimum Age: 60 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Royal Prince Alfred Hospital, Sydney, Sydney, New South Wales, Australia
Newcastle Mater Misericordiae Hospital, Waratah, New South Wales, Australia
Royal Adelaide Hospital, Adelaide, South Australia, Australia
Anti-Cancer Council of Victoria, Melbourne, Parkville, Victoria, Australia
Sir Charles Gairdner Hospital, Perth, Perth, Western Australia, Australia
National Institute of Oncology, Budapest, , Hungary
Hadassah University Hospital, Jerusalem, , Israel
Centro di Riferimento Oncologico - Aviano, Aviano, , Italy
Spedali Civili, Brescia, , Italy
Presidio Ospedaliero-Gorizia, Gorizia, , Italy
Ospedale Civile Rimini, Rimini, , Italy
Ospedale San Eugenio, Rome, , Italy
Auckland Adventist Hospital, Auckland, , New Zealand
Institute of Oncology, Ljubljana, Ljubljana, , Slovenia
Groote Schuur Hospital, Cape Town, Cape Town, , South Africa
Sahlgrenska University Hospital, Gothenburg (Goteborg), , Sweden
University Hospital, Basel, , Switzerland
Inselspital, Bern, Bern, , Switzerland
Centre Hospitalier Universitaire Vaudois, Lausanne, , Switzerland
Kantonsspital - St. Gallen, St. Gallen, , Switzerland
UniversitaetsSpital, Zurich, , Switzerland
Name: Diana Crivellari, MD
Affiliation: Centro di Riferimento Oncologico - Aviano
Role: STUDY_CHAIR