RecruitingNot ApplicableNCT06445738

Post-operative Radiotherapy Omission in Selected Patients With Early Breast Cancer Trial International VErsion (PROSPECTIVE)

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


Sponsor

Breast Cancer Trials, Australia and New Zealand

Enrollment

1,400 participants

Start Date

Jun 6, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Sex: FEMALEMin Age: 50 Years

Plain Language Summary

Simplified for easier understanding

This international trial (PROSPECTIVE) is studying whether selected women with early-stage breast cancer can safely skip radiation therapy after breast-conserving surgery (lumpectomy). It focuses on women with low-risk tumors to see if omitting radiation does not worsen their long-term outcomes. **You may be eligible if...** - You are a woman aged 50 or older with confirmed estrogen receptor-positive and/or HER2-positive breast cancer - Your cancer is in one location in one breast (unifocal, unilateral) - You have a life expectancy of at least 10 years and are willing to be followed for 10 years - You are in reasonably good health (ECOG 0–2) **You may NOT be eligible if...** - Your cancer is triple-negative (ER-negative, PR-negative, HER2-negative) - You have had a previous breast cancer or chest radiation - Your cancer has spread to distant organs - You carry a known breast cancer gene mutation (such as BRCA1 or BRCA2) - You are planning a mastectomy - You have bilateral breast cancer Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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 Center

San Francisco, California, United States

Baylor St Luke's Medical Centre

Houston, Texas, United States

The Chris O'Brien Lifehouse

Camperdown, New South Wales, Australia

Lake Macquarie Private Hospital

Gateshead, New South Wales, Australia

Mater Hospital, Sydney

North Sydney, New South Wales, Australia

Westmead Hospital

Westmead, New South Wales, Australia

Royal Adelaide Hospital

Adelaide, South Australia, Australia

Monash Cancer Centre (MMC Moorabbin)

Clayton, Victoria, Australia

The Royal Melbourne Hospital

Melbourne, Victoria, Australia

View Full Details on ClinicalTrials.gov

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NCT06445738


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