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

NCT06445738 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1400

Last updated 2026-01-15

No results posted yet for this study

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.

Conditions

Interventions

OTHER

Arm B: Standard Treatment

Ineligible for RT omission on study; includes management of MRI-detected lesions.

RADIATION

Arm A: Radiotherapy Omission

Omission of radiotherapy based on pre-surgical MRI and pathology findings at surgery.

Sponsors & Collaborators

  • Breast Cancer Trials, Australia and New Zealand

    lead OTHER

Principal Investigators

  • Bruce Mann, MD · Melbourne Health

  • Steven David, MD · Peter MacCallum Cancer Centre - Moorrabin

  • Alastair Thompson, MD · Baylor College of Medicine

Study Design

Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
50 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-06-06
Primary Completion
2032-06-30
Completion
2039-06-30

Countries

  • United States
  • Australia

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06445738 on ClinicalTrials.gov