Early breast cancer Cancer Malignant neoplasm of breast
Conditions
Interventions
Current interventions as of 09/05/2024:
Eligible patients are those with a higher risk (8% at 5 years) of local recurrence after breast-conserving surgery. After giving consent patients are randomised
Sponsors
University College London (UK)
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: Patients diagnosed with breast cancer and suitable for conserving surgery and radiotherapy, with a cytological or histological confirmation of carcinoma can be included in the study once written informed consent is obtained. All patients should be available for regular follow-up (according to local policies) for at least ten years. At least one of these criteria must be satisfied: 1. Less than 46 years of age 2. More than 45 years of age, but with one of the following poor prognostic factors: 2.1. Lymphovascular invasion 2.2. Gross nodal involvement (not micrometastasis) 2.3. More than one tumour in the breast but still suitable for breast-conserving surgery through a single specimen 3. More than 45 years of age, but with at least two of the following poor prognostic factors 3.1. ER-negative 3.2. Grade 3 histology 3.3. Positive margins at first excision 4. Those patients with large tumours which have responded to neo-adjuvant chemo- or hormone therapy in an attempt to shrink the tumour and are suitable for breast-conserving surgery as a result 5. Lobular carcinoma or Extensive Intraductal Component (EIC) 6. A combination of high-risk factors are present (as predefined in the policy document) that give a high risk of local recurrence
Exclusion criteria
Exclusion criteria: 1. Bilateral breast cancer at the time of diagnosis 2. Patients with any severe concomitant disease that may limit their life expectancy 3. Previous history of malignant disease does not preclude entry if the expectation of relapse-free survival at 10 years is 90% or greater (e.g., non-melanoma skin cancer, CIN etc) 4. No more than 30 days can have elapsed between last breast cancer surgery (not axillary) and randomisation for patients in the post-pathology stratification unless part of a specific clinical trial that addresses the question of timing or tumour bed can be reliably identified, e.g. by ultrasound
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Local recurrence | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Site of relapse within the breast 2. Relapse-free survival and overall survival 3. Local toxicity/morbidity | — |
Countries
Australia, Canada, Denmark, England, France, Germany, Italy, Norway, Poland, Switzerland, United Kingdom, United States of America
Outcome results
None listed