Randomised trial testing dose escalated intensity modulated radiotherapy in women with higher than average local tumour recurrence risk after breast conservation therapy for early breast cancer

Phase 3

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

• Registration Number: ISRCTN47437448
• Lead Sponsor: Institute of Cancer Research (UK)

Brief Summary

2006 Protocol article in http://www.ncbi.nlm.nih.gov/pubmed/17051947 protocol 2007 Other publications in https://doi.org/10.1016/j.clon.2007.01.320 forward planning analysis 2011 Other publications in https://www.ncbi.nlm.nih.gov/pubmed/20605349 Trial planning 2014 Interim results article in https://www.ncbi.nlm.nih.gov/pubmed/25642565 Results of observational sub-study comparing image-guided radiotherapy and standard imaging. 2015 Interim results article in https://www.ncbi.nlm.nih.gov/pubmed/26492402 clinical impact results 2019 Abstract results in https://doi.org/10.1158/1538-7445.SABCS18-GS4-05 3-year adverse event results presented at San Antonio Breast Cancer Symposium (added 30/12/2022) 2021 Abstract results in https://www.estro.org/Congresses/ESTRO-2021/499/profferedpapers16-late-breakingabstracts/3418/importhightrial-doseescalatedsimultaneousintegrate Presented at ESTRO (added 30/12/2022) 2023 Results article in https://pubmed.ncbi.nlm.nih.gov/37302395/ (added 12/06/2023)

Detailed Description

Not available

Study Timeline

• Study Start: 2007-04-17
• Last Update Posted: 26 August 2024
• Study Completion: 2025-09-16

Recruitment & Eligibility

• Status: Ongoing
• Sex: Female
• Target Recruitment: 2621

Inclusion Criteria

Current inclusion criteria as of 26/02/2019:
1. Operable unilateral breast cancer (T1-3, pN0- pN3a, M0 at presentation)
2. Breast conserving surgery
3. Age greater than or equal to 18 years
4. Histological confirmation of invasive carcinoma
5. Complete microscopic resection
6. Patient requires a tumour bed boost plus whole breast radiotherapy for inclusion within the trial
7. Written informed consent and available for follow-up

Previous inclusion criteria:
1. Age greater than or equal to 18 years
2. Operable, unilateral breast cancer (T1-3, N0-1, M0 at presentation)
3. Breast conserving surgery
4. Histological confirmation of invasive carcinoma
5. Complete microscopic resection
6. Patient requires a tumour bed boost plus whole breast radiotherapy
7. Written informed consent and availability for follow-up

Exclusion Criteria

Current exclusion criteria as of 26/02/2019:
1. Past history of malignancy except:
1.1. Basal cell skin cancer and CIN cervix uteri or
1.2. Non breast malignancy allowed if treated with curative intent and at least 5 years disease free
2. Mastectomy
3. Concomitant chemotherapy (primary or sequential chemotherapy allowed).
4. Presence of ipsilateral breast implant

Previous exclusion criteria:
1. Previous malignancy (other than non-melanomatous skin cancer and Carcinoma In Situ [CIS] of the cervix)
2. Mastectomy
3. Concomitant chemotherapy (sequential chemotherapy allowed)
4. Radiotherapy prescription includes posterior axillary boost field

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Current primary outcome measure as of 26/02/2019:<br>Local tumour control measured by reported ipsilateral events at 5 years<br><br>Previous primary outcome measure:<br>Palpable induration in the ipsilateral breast, measured at yearly follow up visits by physician examination and also at baseline (before radiotherapy) and at years three and five by photographic assessment years. Outcome from these will be correlated at years three and five.