IBCSG 10-93 - Surgical therapy with or without axillary node clearance for breast cancer in the elderly who receive adjuvant therapy with Tamoxife
- Conditions
- Breast CancerCancer - Breast
- Registration Number
- ACTRN12607000024448
- Lead Sponsor
- International Breast Cancer Study Group
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Female
- Target Recruitment
- 1020
Postmenopausal • Clinically operable breast cancer, clinically N0, diagnosed either by cytology or histology, and are before axillary clearance. • No definitive surgery and no axillary clearance performed.• Complete excisional biopsy without axillary clearance• Tumour confined to the breast with no detected or suspected metastases • Informed consent• Geographically accessible for follow-up• Completion of baseline quality of life assessment.
• Already undergone definitive surgery with axillary clearance or an axillary biopsy only.• Patients who have malignant breast tumours other than carcinoma• Patients with clinically N1 or N2 lymph nodes• Patients who have T4 inflammatory carcinoma with ulceration or infiltration of skin, with peau d’orange, or clinical appearance of axillary involvement.• Bilateral malignancy, except patients with squamous or basal cell carcinoma of the skin or adequately treated in situ carcinoma of the cervix• Have receive prior therapy for breast cancer including irradiation, surgery, chemotherapy and /or hormonal therapy.• Non-malignant systemic disease which prevent them from being subject to any of the treatment options or prolonged follow up• Psychiatric or addictive disorders• Have bone scintigrams showing hot spots or skeletal pain which cannot be confirmed as benign disease.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method