None listed
Conditions
Brief summary
Breast cancer usually first spreads to lymph nodes in the axilla (armpit). Sentinel node biopsy is a way of finding and removing the lymph nodes most likely to contain cancer. Women found to have cancer in their sentinel nodes usually undergo an axillary clearance. This involves removal of most lymph nodes in the armpit but can cause side effects such as lymphoedema (arm swelling) and other problems. This international phase III trial will determine if an axillary clearance is warranted for women who have only small clumps of cancer cells, called micrometastases, found in the sentinel lymph nodes.
Interventions
The trial is being conducted internationally by the International Breast Cancer Study Group. The trial is co-ordinated in Australia and New Zealand by Breast Cancer Trials (formerly the Australia & New Zealand Breast Cancer Trials Group). The aim of this clinical trial is to try to determine whether long term survival for women who do not have an axillary dissection is different from women who do have an axillary dissection when the sentinel lymph node contains micrometastases. IBCSG 23-01 is an
The trial is being conducted internationally by the International Breast Cancer Study Group. The trial is co-ordinated in Australia and New Zealand by Breast Cancer Trials (formerly the Australia & New Zealand Breast Cancer Trials Group). The aim of this clinical trial is to try to determine whether long term survival for women who do not have an axillary dissection is different from women who do have an axillary dissection when the sentinel lymph node contains micrometastases. IBCSG 23-01 is an international, multicentre, randomised clinical trial of 1960 patients with histologically proven, clinically node-negative breast cancer who have undergone primary breast surgery and sentinel node biopsy with micrometastases identified in the sentinel node. Women will be randomised in a 2-arm design to receive one of the following: a. Axillary dissection b. No axillary dissection
Sponsors
Breast Cancer Trials
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Healthy volunteers
No
Inclusion criteria
Patients of any age with pathological diagnosis of unifocal breast carcinoma with micrometastases in the sentinel node, who have completed baseline Quality of Life evaluations, and geographically accessible for follow up and who have signed written informed consent.
Exclusion criteria
Patients with clinical evidence of distant metastases; palpable axillary nodes; Pagets disease without invasive cancer; patients who have received a chemoprevention agent within a year of randomization; patients who are pregnant or lactating; patients with previous or concomitant malignancy.
Outcome results
None listed