Breast cancer Cancer Malignant neoplasm of breast
Conditions
Interventions
Patients consent and register for pre-screening Ki67 research testing and 5 slides from the diagnostic block are forwarded for analysis to the central laboratory. Breast conserving surgery will procee
Sponsors
Institute of Cancer Research
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Provision of written informed consent to participate in the PRIMETIME study 2. Provision of slides for research testing and availability of KI67 result (contact ICR-CTSU to confirm) 3. Women aged =60 years (younger patients are eligible if they are post-menopausal and have co-morbidities that imply a high risk of radiotherapy toxicity e.g. significant cardiovascular disease with left sided breast cancer) 4. Women having had breast conserving surgery with complete resection of tumour tissue (=1 mm microscopic, circumferential margins of normal tissue from invasive cancer and DCIS) 5. AJCC staging of pT1/pN0/M0 (DCIS is allowed in combination with invasive breast cancer; isolated tumour cells in axillary nodes are allowed) 6. Histological confirmation of grade 1 or 2 invasive breast cancer 7. Oestrogen receptor (ER) positive according to local practice. The H score must be available. 8. Progesterone receptor (PR) positive according to local practice. The percentage positivity must be available. 9. Human epidermal growth factor receptor (HER2) negative according to local practice 10. Patients must be recommended for =5 years adjuvant endocrine therapy according to local policy and in the investigator’s opinion, deemed able to comply with the duration of treatment
Exclusion criteria
Exclusion criteria: 1. Patients known to have lymphovascular space invasion and/or axillary nodal micrometastases or macrometastases. 2. Patients with a past history of malignancy excep: 2.1. Basal cell skin cancer and CIN cervix uteri 2.2.Treated, localised squamous cell carcinoma of the skin 2.3. Malignancies treated with curative intent and the patient has been disease free =5 years 3. Patients who have had an ipsilateral mastectomy 4. Patients who have received neoadjuvant therapy (endocrine or cytotoxic chemotherapy with therapeutic intent) or who are deemed by the MDT to require adjuvant cytotoxic chemotherapy 5. Patients with mammographically occult breast cancers, ie. present with lump, but not visible on mammogram
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Ipsilateral breast local relapse rate 5 years from study registration is assessed through patient note review. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Ipsilateral breast local relapse rate is measured by patient note review 10 years from study registration 2. Regional relapse rate is measured by patient note reviewat 5 and 10 years 3. Distant relapse rate is measured by patient note review at 5 and 10 years 4. Overall survival is measured by patient note review at 5 and 10 years 5. Breast cancer specific survival is measured by patient note review at 5 and 10 years | — |
Countries
England, Scotland, United Kingdom, Wales
Contacts
Public ContactLorna Smith
Outcome results
None listed