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PROSPECTIVE Trial: Radiotherapy Omission for Early Breast Cancer

The PROSPECTIVE trial is studying if some women with early breast cancer can safely skip radiotherapy after surgery. This study uses pre-surgery MRI (Magnetic Resonance Imaging) and pathology results to identify patients who might have a very low risk of their cancer returning. You could be eligible if you are a woman aged 50 or older with ER-positive and/or HER2-positive invasive breast cancer. The study wants to see if the cancer comes back in the same breast (called ipsilateral invasive recurrence) in low-risk patients who don't receive radiotherapy. They will follow participants for at least 5 years to measure this.

Study design
This interventional study plans to enroll 1400 women. It has two groups: one that omits radiotherapy and another that receives standard treatment.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for a median of 5 years to check for cancer recurrence.

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NCT06445738

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

Recruiting
NAAges 50+Interventional
Breast Cancer Trials, Australia and New Zealand
~1,400 participants
Updated 2026-01-15 on ClinicalTrials.gov
What's tested:Arm A: Radiotherapy OmissionArm B: Standard Treatment

At a glance

Recruiting sites
3 of 9 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Ipsilateral Invasive Recurrence Rate (IIRR) in low-risk patients omitting RT at a median of 5 years follow up
Measured over Median of 5 years follow up (when 300th low risk patient in Arm A reaches 5 years follow up)

Conditions

Breast Cancer
Breast Cancer Female

Explore related trials

Breast CarcinomaERBB2 Gene

Where it's being run

9 sites across 5 states
New South Wales4
Victoria2
California1
Texas1
South Australia1

Study leadership

  • Bruce Mann, MD · STUDY_CHAIR · Melbourne Health
  • Steven David, MD · STUDY_CHAIR · Peter MacCallum Cancer Centre - Moorrabin
  • Alastair Thompson, MD · STUDY_CHAIR · Baylor College of Medicine

Who to contact

Heath Badger
[email protected]
+61 2 4925 5239
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Oestrogen receptor and progesterone receptor status of invasive cancer will be assessed by immunohistochemistry on the diagnostic core biopsy specimen. The IHC results will be reported as percentage of nuclei stained and a score of intensity from negative, weak, intermediate or high staining
0 or 1+ (HER2 negative): No staining or membrane staining that is incomplete and is faint/barely perceptible and in ≤ 10% of tumour cells (0); or incomplete membrane staining that is faint/barely perceptible and in \> 10% of tumour cells (1+).
2+ (equivocal): weak to moderate complete membrane staining observed in \> 10% of tumour cells. Must order reflex test (same specimen using ISH) or order a new test (new specimen if available using HIS or ISH).
3+ (HER2 positive): Circumferential membrane staining that is complete, intense and in \> 10% of tumour cells.
Where histopathology is unable to identify a 'bridge' of tumour tissue joining two or more apparent invasive cancer foci the following will be used to confirm unifocal disease:
All foci must be of the same histological subtype
All foci must have the same hormone (ER and PR) and HER2 status.

What this trial measures

  • Ipsilateral Invasive Recurrence Rate (IIRR) in low-risk patients omitting RT at a median of 5 years follow upMedian of 5 years follow up (when 300th low risk patient in Arm A reaches 5 years follow up)

    To determine the ipsilateral invasive recurrence rate (IIRR) in lower risk patients with unequivocally unifocal breast cancer and on breast MRI and favourable clinico-pathological features.