A Two-arm, Non-randomised, Prospective, Multicentre Study Using Magnetic Resonance Imaging (MRI) Findings and Pathology Features to Select Patients With Early Breast Cancer for Omission of Post-operative Radiotherapy
Breast Cancer Trials, Australia and New Zealand
Summary
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.
Description
Breast cancer is the most common serious malignancy in women and most patients are suitable for therapy involving surgery and adjuvant radiotherapy (RT). For most patients, there is a lack of evidence that breast conserving surgery without adjuvant RT is safe and therefore patients bear the costs, inconvenience and morbidity of RT. Prior attempts to identify large subsets of patients for whom RT can be safely omitted based on clinicopathological features of the index cancer have had limited success, and so RT is currently omitted only in some women over 65 or 70 with small low risk cancers. Id…
Eligibility
- Age range
- 50+ years
- Sex
- Female
- Healthy volunteers
- No
Inclusion Criteria: For inclusion in the study at Registration, participants must fulfil all of the following criteria: 1. Has provided written, informed consent to participate in the study. 2. Female participants ≥ 50 years old with histologically\* confirmed ER-positive and/or HER2-positive invasive breast cancer. 3. Has a life expectancy of at least 10 years and suitable for prolonged follow up for 10 years. 4. Breast imaging indicating unifocal, unilateral breast cancer must have been performed before pre-registration. 5. Willing/able to have surgery within 8 weeks of registration or pre…
Interventions
- RadiationArm A: Radiotherapy Omission
Omission of radiotherapy based on pre-surgical MRI and pathology findings at surgery.
- OtherArm B: Standard Treatment
Ineligible for RT omission on study; includes management of MRI-detected lesions.
Locations (9)
- UCSF Breast Care CenterSan Francisco, California
- Baylor St Luke's Medical CentreHouston, Texas
- The Chris O'Brien LifehouseCamperdown, New South Wales
- Lake Macquarie Private HospitalGateshead, New South Wales
- Mater Hospital, SydneyNorth Sydney, New South Wales
- Westmead HospitalWestmead, New South Wales