Actively Recruiting
Post-operative Radiotherapy Omission in Selected Patients With Early Breast Cancer Trial International VErsion (PROSPECTIVE)
Led by Breast Cancer Trials, Australia and New Zealand · Updated on 2026-01-15
1400
Participants Needed
9
Research Sites
729 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The PROSPECTIVE trial aims to find out if using the results of Magnetic Resonance Imaging (MRI) for early breast cancer can select people to not have radiotherapy and still have a low chance of the cancer coming back after surgery. The main question it aims to answer is: \* Will cancer come back in the same breast as the original cancer in patients who have surgery for their breast cancer, but who don't have radiotherapy afterwards because the results of an MRI before surgery showed favourable characteristics for not having radiotherapy.
CONDITIONS
Official Title
Post-operative Radiotherapy Omission in Selected Patients With Early Breast Cancer Trial International VErsion (PROSPECTIVE)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female participants aged 50 years or older with confirmed estrogen receptor-positive and/or HER2-positive invasive breast cancer
- Life expectancy of at least 10 years and able to follow up for 10 years
- Breast imaging showing unifocal, unilateral breast cancer before registration
- Willing and able to have surgery within 8 weeks of registration or pre-operative MRI, whichever is later
- ECOG performance status of 0 to 2
- Provided written informed consent to participate in the study
You will not qualify if you...
- Triple negative breast cancer (ER-negative, PR-negative, and HER2-negative)
- Previous invasive breast cancer or ductal carcinoma in situ (DCIS) in either breast
- Prior radiotherapy to the breast or chest
- Planning to have a mastectomy for the current cancer
- Lymphovascular invasion reported on diagnostic biopsy
- Multifocal or multicentric breast cancer on imaging before registration
- Distant metastasis at diagnosis
- Bilateral breast cancer
- Known mutation in breast cancer predisposition genes (e.g., BRCA1, BRCA2, PALB2, CHEK2, ATM, CDK1, p53, BARD1, RAD51C, RAD51D, CDH1, STK11, PTEN)
- Contraindication to breast MRI scanning
- Other illnesses limiting life expectancy to 10 years or less
- Moderate or marked background parenchymal enhancement in the breast with cancer on MRI
- Unable to give informed consent
AI-Screening
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Trial Site Locations
Total: 9 locations
1
UCSF Breast Care Center
San Francisco, California, United States, 94158
Not Yet Recruiting
2
Baylor St Luke's Medical Centre
Houston, Texas, United States, 77030
Not Yet Recruiting
3
The Chris O'Brien Lifehouse
Camperdown, New South Wales, Australia, 2050
Not Yet Recruiting
4
Lake Macquarie Private Hospital
Gateshead, New South Wales, Australia, 2290
Not Yet Recruiting
5
Mater Hospital, Sydney
North Sydney, New South Wales, Australia, 2060
Actively Recruiting
6
Westmead Hospital
Westmead, New South Wales, Australia, 2145
Not Yet Recruiting
7
Royal Adelaide Hospital
Adelaide, South Australia, Australia, 5000
Not Yet Recruiting
8
Monash Cancer Centre (MMC Moorabbin)
Clayton, Victoria, Australia, 3168
Actively Recruiting
9
The Royal Melbourne Hospital
Melbourne, Victoria, Australia, 3000
Actively Recruiting
Research Team
H
Heath Badger
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
OTHER
Number of Arms
2
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