A clinical trial testing a one week schedule of whole breast radiotherapy against a three week schedule

Phase 3

• Conditions: Breast cancer; Cancer; Malignant neoplasm of breast

• Registration Number: ISRCTN19906132
• Lead Sponsor: Institute of Cancer Research

Brief Summary

2020 Results article in https://pubmed.ncbi.nlm.nih.gov/32580883/ results (added 26/06/2020) 2023 Results article in https://doi.org/10.3310/wwbf1044 (added 23/11/2023)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-05-31
• Last Update Posted: 4 December 2023
• Study Completion: 2028-10-02

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 4579

Inclusion Criteria

1. Age more than or equal to 18 years
2. Female or male
3. Invasive carcinoma of the breast
4. Breast conservation surgery or mastectomy (reconstruction allowed but not with implant. Tissue expanders with distant metal ports are allowed)
5. Axillary staging and/or dissection
6. Complete microscopic excision of primary tumour
7. Stage pT1-3 pN0-1 M0 disease
8. Written informed consent
9. Able to comply with follow up

Concurrent trastuzumab and hormone therapy is allowed

Exclusion Criteria

1. Past history of malignancy except basal cell skin cancer and cervical intraepithelial neoplasia (CIN) or non-breast malignancy allowed if treated with curative intent and at least 5 years disease free
2. Contralateral breast cancer, including ductal carcinoma in-situ (DCIS), irrespective of date of diagnosis
3. Breast reconstruction using implants
4. Concurrent cytotoxic chemotherapy (sequential neoadjuvant or adjuvant cytotoxic therapy allowed)
5. Radiotherapy to any regional lymph node areas (excepting lower axilla included in standard tangential fields to breast/chest wall)

Study & Design

• Study Type: Interventional
• Study Design: Not specified