Breast cancer (female) - Clinical trial details 

Recruitment status:

Recruiting

Primary Sponsor:

The Institute of Cancer Research (UK)

Recruitment countries:

United Kingdom

Health condition studied:

Breast cancer
Cancer
Malignant neoplasm of breast

URL:

Link to the clinical trial website

About the trial

Interventions:

Patients will be randomised equally between a standard 3 week schedule and two 1 week test schedules of whole breast radiotherapy

Whole breast radiotherapy schedules:
Standard group - 40Gy in 15 fractions over 15 days (not weekends)
Test group 1 - 27Gy in 5 fractions over 5 days (not weekends)
Test group 2 - 26Gy in 5 fractions over 5 days (not weekends)

Patients will be followed up for a minimum of 10 years.

There are Quality of Life and a photographic sub-studies, each with 2196 patients. Quality of Life questionnaires will be completed at baseline, 6, months and 2, 5 and 10 years post randomisation. Photographs will be taken at baseline and 2, 5 and 10 years post randomisation.

Key inclusion and exclusion criteria:

• 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)

• Age minimum:
• Age maximum:
• Gender: Both

Primary outcomes:

Ipsilateral local tumour control: Will be reported at the annual follow up visits. The tests will be performed when the need arises i.e. when the patient feels unwell or reports another lump etc. The tests will be carried out as routine clinical examinations i.e. X rays, computerised tomography (CT) scans, magnetic resonance imaging (MRI), ultrasound.

Secondary outcomes:

1. Early and late adverse effects in normal tissues
2. Quality of life at baseline, 6, months and 2, 5 and 10 years post randomisation
3. Contralateral primary tumours, regional and distant metastases
4. Survival

Target sample size:

4000

Study type:

Interventional

Study design:

Phase III randomised controlled multi centre trial (Treatment)

Contacts:

• Name:
• Address:
• Phone:
• Email:
• Affiliation:

• Name: John Yarnold
• Address: Academic Radiotherapy Orchard House Downs Road
• Phone:
• Email: john.yarnold@icr.ac.uk
• Affiliation:

Technical details

Scientific title:

Randomised clinical trial testing a one week course of curative whole breast radiotherapy against a standard three week schedule in terms of local cancer control and late adverse effects in patients with early breast cancer

Sources of monetary support:

NIHR Health Technology Assessment Programme - HTA (UK) (09/01/47)

Secondary sponsors:

Main ID:

ISRCTN19906132

Secondary ID:

HTA 09/01/47, ICR-CTSU/2010210026

Register:

ISRCTN

Date of registration:

31/05/2024

Date of first enrollment:

01/09/2024

Last refreshed:

13 January 2025