Optimal personalised treatment of early breast cancer using multiparameter analysis
- Conditions
- Breast cancerCancerMalignant neoplasm of breast
- Registration Number
- ISRCTN42400492
- Lead Sponsor
- niversity College London
- Brief Summary
2016 Results article in https://www.ncbi.nlm.nih.gov/pubmed/26867046 results
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Ongoing
- Sex
- All
- Target Recruitment
- 5000
Current participant inclusion criteria (amended 20/10/2020) and added 14/02/2024:
1. Female or male, age = 40
2. Excised invasive breast cancer with local treatment either completed or planned according to trial guidelines.
3. ER positive (>10% of tumour cells stained positive) as determined by the referring site in a laboratory meeting national external quality assurance standards and in accordance with national or ASCO-CAP guidelines (83).
4. HER2 negative (IHC 0-1+, or ISH negative/non-amplified) as determined by the referring site in a laboratory meeting national external quality assurance standards and in accordance with national or ASCO-CAP guidelines (84).
5. Tumour size and axillary lymph node status; one of the following must apply:
1.1. 4-9 lymph nodes involved AND any invasive tumour size.
1.2. 1-3 nodes involved, with at least 1 node containing a macrometastasis (i.e. deposit >2mm diameter) AND any invasive tumour size.
1.3. 1-3 lymph nodes involved with micrometastases only (i.e. deposit >0.2-2mm diameter) AND invasive tumour size = 20mm.
1.4. Node negative AND invasive tumour size = 30mm.
2. Considered appropriate for adjuvant chemotherapy by the treating physician.
3. Patient must be fit to receive chemotherapy and other trial-specified treatments with no concomitant medical, psychiatric or social problems that might interfere with informed consent, treatment compliance or follow up.
4. Multiple ipsilateral cancers are permitted provided at least one tumour fulfils the tumour size and axillary lymph node entry criteria, and none meet any of the exclusion criteria.
5. Bilateral cancers are permitted provided the tumour(s) in one breast meets the eligibility criteria and the other, contralateral tumour is not ER negative and/or HER2 positive and not clinically significant.
6. Short term pre-surgical treatment with endocrine therapy including in combination with non-cytotoxic agents is allowed providing that the duration of treatment does not exceed 8 weeks.
7. Informed consent for the study.
Previous Inclusion criteria at recruitment start (17/01/2017) added 14/02/2024:
Main trial:
1. Female or male, age >= 40
2. Excised invasive breast cancer with local treatment either completed or planned according to trial guidelines.
3. ER positive (Allred score >=3 or H-score >=10 or >1% of tumour cells stained positive) as determined by the referring site (in a laboratory meeting NEQAS standards).
4. HER2 negative (IHC 0-1+, or ISH negative/non-amplified (ratio of HER2/chromosome 17 <2.00 and copy number <6)) as determined by the referring site (in a laboratory meeting NEQAS standards).
5. Tumour size and axillary lymph node status; one of the following must apply:
5.1. 4-9 lymph nodes involved AND any invasive tumour size.
5.2 1-3 nodes involved, with at least 1 node containing a macrometastasis (i.e. deposit >2mm diameter) AND any invasive tumour size.
5.3. 1-3 lymph nodes involved with micrometastases only (i.e. deposit >0.2-2mm diameter) AND invasive tumour size = 20mm.
5.4 node negative AND invasive tumour size = 30mm.:
6. Considered appropriate for adjuvant chemotherapy by treating physician.
7. Patient must be fit to receive chemotherapy and other trial-specified treatments with no concomitant medical, psychiatric or social problems that might interfere with informed consent, treatment compliance or follow up.
8. Bilateral cancers are permitted provided at least one tumour fulfils the entry criteria and none meet any of the
Current participant exclusion criteria (amended 17/09/2022) and added 14/02/2024:
1. =10 involved axillary lymph nodes (with either macrometastases and/ or micrometastases) or involvement of any of internal mammary, supraclavicular and infraclavicular nodes.
1.1. NOTE: Internal mammary lymph nodes identified by anatomical imaging studies alone will be considered uninvolved where the diameter is <10mm.
2. ER negative/low OR HER2 positive/amplified tumour (as determined by the referring site).
3. Metastatic disease.
4. Previous diagnosis of malignancy unless:
4.1 managed by local treatment only AND disease-free for 10 years.
4.2 ductal carcinoma in situ (DCIS) or pleomorphic lobular carcinoma in situ (pleomorphic LCIS) of the breast managed by local treatment only; treatment with anti-oestrogens is not permitted.
4.3 any other in situ carcinoma as defined by the International Classification of Diseases for Oncology (ICD-O) including basal cell carcinoma of skin and cervical intraepithelial neoplasia.
5. Pre-operative anti-cancer treatments except short-term endocrine therapy administered as per the inclusion criteria.
6. Adjuvant systemic treatment commenced prior to trial entry* except endocrine therapy, which must be discontinued prior to starting trial-allocated chemotherapy.
7. Treatment with agents, including ovarian suppression, known to influence breast cancer growth but prescribed for other indications within one year of trial entry* except as follows:
8. Use of oestrogen replacement therapy (HRT) provided this is stopped before surgery.
9. Drugs administered for in vitro fertilization or fertility preservation.
10. Use of hormonal contraception.
11. Trial entry* and randomisation more than 12 weeks after completion of breast cancer surgery. Trial entry should ordinarily be within 8 weeks of final surgery.
12. Planned further surgery for breast cancer, including axillary surgery, to take place after trial entry*, except either re-excision or completion mastectomy for close or positive/involved margins which may be undertaken following completion of chemotherapy if given.
*Trial entry is dated from the earlier of participant signature of the consent form or the giving of remote verbal consent.
Previous participant exclusion criteria at recruitment start (17/01/2017), added on 14/02/2024:
Main trial
1. >=10 involved axillary nodes (with either macrometastases and/ or micrometastases) or evidence for internal mammary node involvement.
2. ER negative OR HER2 positive/amplified (as determined by the referring site).
3. Metastatic disease.
4. Previous diagnosis of malignancy unless:
4.1. managed by surgical treatment only and disease free for 10 years
4.2. basal cell carcinoma of skin or cervical intraepithelial neoplasia or
4.3. ductal carcinoma in situ (DCIS) of the breast treated with surgery only
4.4. lobular carcinoma in situ (LCIS) or lobular neoplasia of the breast.
5. The use of oestrogen replacement therapy (HRT) at the time of surgery. Patients who are taking HRT at the time of diagnosis are eligible provided the HRT is stopped before surgery.
6. Pre-surgical chemotherapy, endocrine therapy or radiotherapy for breast cancer. Treatment with endocrine agents known to be active in breast cancer including ovarian suppression is permitted provided this was completed >1 year prior to study entry.
7. Commencement of adjuvant treatment prior to trial entry. Short-term endocrine therapy initiated because of, for instance, prolonged
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method