10-93Surgical Therapy With or Without Axillary Node Clearance for Breast Cancer in the Elderly Who Receive Adjuvant Therapy With Tamoxifen.
tamoxifen citrate
+ conventional surgery
+ radiation therapy
Breast Diseases+3
+ Neoplasms
+ Neoplasms by Site
Treatment Study
Summary
Study start date: May 1, 1993
Actual date on which the first participant was enrolled.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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.473 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Female
Biological sex of participants that are eligible to enroll.Over 60 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
DISEASE CHARACTERISTICS: Histologically or cytologically confirmed stage I or IIA breast carcinoma that is considered operable No prior axillary clearance or biopsy Complete excisional biopsy of primary tumor without axillary clearance or biopsy allowed Suspicious manifestations of metastatic disease (e.g., hot spots on bone scan or skeletal pain of unknown cause) must be proven benign No bilateral breast cancer (any mass in contralateral breast must be proven benign by biopsy) Hormone receptor status: Not specified PATIENT CHARACTERISTICS: Age: 60 and over Sex: Female Menopausal status Postmenopausal Performance status: Not specified Hematopoietic: WBC greater than 4,000/mm^3 Platelet count greater than 100,000/mm^3 Hepatic: Bilirubin less than 1.1 mg/dL AST less than 60 U/L Renal: Creatinine less than 1.3 mg/dL Cardiovascular: Normal cardiac function No history of congestive heart failure Other: No nonmalignant systemic disease that would preclude protocol therapy or prolonged follow-up No psychiatric or addictive disorder that would preclude protocol therapy or informed consent No other prior or concurrent malignancy except nonmelanomatous skin cancer or adequately treated carcinoma in situ of the cervix Geographically accessible for follow-up PRIOR CONCURRENT THERAPY: Biologic therapy: No prior biologic therapy for breast cancer Chemotherapy: No prior chemotherapy for breast cancer Endocrine therapy: No prior endocrine therapy for breast cancer Radiotherapy: No prior radiotherapy for breast cancer Surgery: See Disease Characteristics
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.2 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalGroup II
ExperimentalStudy Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 21 locations
Royal Prince Alfred Hospital, Sydney
Sydney, AustraliaOpen Royal Prince Alfred Hospital, Sydney in Google MapsNewcastle Mater Misericordiae Hospital
Waratah, AustraliaRoyal Adelaide Hospital
Adelaide, AustraliaAnti-Cancer Council of Victoria, Melbourne
Parkville, Australia