Breast cancer Cancer Malignant neoplasm of breast
Conditions
Interventions
Current interventions as of 14/06/2019:
The trial interventions are either:
1. Adjuvant therapy alone (intervention)
Axillary radiotherapy is not allowed when randomised to this group.
2. Adjuvant th
Sponsors
University Hospitals of Derby and Burton NHS Foundation Trust
Eligibility
Sex/Gender
Female
Age
18 Years to 100 Years
Inclusion criteria
Inclusion criteria: Current inclusion criteria as of 14/06/2019: Women will be eligible for inclusion only if ALL of the following criteria apply: 1. 18 years or older 2. Unifocal or multi-focal invasive tumour with lesion =5 cm in its largest dimension, measured pathologically or largest invasive tumour diameter on radiology should be used for women who are randomised intra-operatively or undergo sentinel node biopsy before neoadjuvant therapy (tumour size should be based only on the single largest tumour; do not add the sizes together from the multiple foci) 3. At sentinel node biopsy have 1 or 2 nodes with macrometastases (tumour deposit >2.0mm in largest dimension or defined as macrometastasis on molecular assay) 4. Fit for axillary treatment and adjuvant therapy 5. Have given written informed consent Previous inclusion criteria: Women will be eligible for inclusion only if ALL of the following criteria apply: 1. 18 years or older 2. Unifocal or multifocal invasive tumour with lesion =5 cm in its largest dimension, measured pathologically or for women who are randomised intraoperatively largest tumour diameter on mammogram or ultrasound. 3. No axillary nodal metastasis on clinical and ultrasound examination. 4. At sentinel node biopsy have 1 or 2 sentinel nodes with macrometastases (tumour deposit >2.0mm in largest dimension or defined as macrometastasis on molecular assay) 5. Fit for axillary treatment and adjuvant therapy 6. Have given written informed consent
Exclusion criteria
Exclusion criteria: Current exclusion criteria as of 14/06/2019: Women will be excluded if they have: 1. Bilateral invasive breast cancer 2. More than 2 nodes with macrometastases 3. Neoadjuvant therapy for breast cancer except: 3.1. If sentinel node biopsy performed prior to neoadjuvant therapy in women with early breast cancer 3.2. Short duration of neoadjuvant endocrine therapy is acceptable (up to 3 months) 4. Previous axillary surgery on the same body side as the scheduled sentinel node biopsy 5. Not receiving adjuvant systemic therapy 6. Previous cancer less than 5 years previously or concomitant malignancy except: 6.1. Basal or squamous cell carcinoma of the skin or 6.2. In situ carcinoma of the cervix or 6.3. In situ melanoma 6.4. Contra- or ipsilateral in situ breast cancer Previous exclusion criteria: Women will be excluded if they have: 1. Bilateral breast cancer 2. More than 2 sentinel node macrometastases or extranodal invasion 3. Neoadjuvant therapy for breast cancer 4. Previous axillary surgery on the same body side as the scheduled sentinel node biopsy 5. Not fit or eligible to receive adjuvant systemic therapy 6. Previous or concomitant malignancy except: 6.1. Adequately treated basal or squamous cell carcinoma of the skin or 6.2. Adequately treated in situ carcinoma of the cervix or 6.3. Adequately treated in situ melanoma 6.4. Contra- or ipsilateral in situ breast cancer
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Axillary recurrence; Timepoint(s): at 5 years | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Anxiety; Timepoint(s): assessed at 3, 6, 12, 24, 36 months 2. Arm morbidity; Timepoint(s): assessed at 3, 6, 12, 24 and 36 months 3. Axillary recurrence free survival; Timepoint(s): assessed at 6, 12, 24, 36, 48 and 60 months 4. Contralateral breast cancer; Timepoint(s): assessed at 6, 12, 24, 36, 48 and 60 months 5. Disease free survival; Timepoint(s): assessed at 6, 12, 24, 36, 48 and 60 months 6. Distant metastasis; Timepoint(s): assessed at 6, 12, 24, 36, 48 and 60 months 7. Economic evaluation; Timepoint(s): assessed at 3, 6, 12, 24, 36 months 8. Local (breast or chest wall) recurrence; Timepoint(s): assessed at 6, 12, 24, 36, 48 and 60 months 9. Non-breast malignancy; Timepoint(s): assessed at 6, 12, 24, 36, 48 and 60 months 10. Overall survival; Timepoint(s): assessed at 6, 12, 24, 36, 48 and 60 months 11. Quality of life; Timepoint(s): assessed at 3, 6, 12, 24, 36 months 12. Regional (nodal) recurrence; Timepoint(s): assessed at 6, 12, 24, 36, 48 and 60 months 13. Time to axillary recurrence; Timepoint(s): assessed at 6, 12, 24, 36, 48 and 60 months | — |
Countries
Australia, England, New Zealand, United Kingdom
Contacts
Public ContactMickey Lewis
Outcome results
None listed