None listed
Conditions
Brief summary
It is unclear whether patients who do not undergo an axillary dissection and receive further systemic treatment, have a similar prognosis to those with axillary clearance who receive the same therapy. The focus of this international trial is to determine the importance of an axillary node dissection for breast cancer patients 60 years or older who receive Tamoxifen as an ongoing treatment. Particular attention will also be given to the quality of life of the patients over the first six years of the study.
Interventions
Arm A: Either a total mastectomy with axillary clearance (removal of the axillary lymph nodes), or a lesser procedure (quadrantectomy or lumpectomy with radiotherapy to the conserved breast) with axillary lymph node dissection followed by Tamoxifen (20mg orally daily) for the duration of 5 years or until relapse.
Arm B: either a total mastectomy without axillary clearance, or a lesser procedure (quadrantectomy or lumpectomy with radiotherapy to the conserved breast) without axillary lymph node
Arm A: Either a total mastectomy with axillary clearance (removal of the axillary lymph nodes), or a lesser procedure (quadrantectomy or lumpectomy with radiotherapy to the conserved breast) with axillary lymph node dissection followed by Tamoxifen (20mg orally daily) for the duration of 5 years or until relapse. Arm B: either a total mastectomy without axillary clearance, or a lesser procedure (quadrantectomy or lumpectomy with radiotherapy to the conserved breast) without axillary lymph node dissection followed by Tamoxifen (20mg orally daily) for the duration of 5 years or until relapse.
Sponsors
International Breast Cancer Study Group
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
60 Years to No maximum
Healthy volunteers
No
Inclusion criteria
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.
Exclusion criteria
• 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.
Outcome results
None listed