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

Part of paid clinical trials in San Francisco, California.

Sponsor
Breast Cancer Trials, Australia and New Zealand
Study ID
NCT06445738
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
FEMALE
Age
50 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Arm A: Radiotherapy Omission — RADIATION
    Omission of radiotherapy based on pre-surgical MRI and pathology findings at surgery.
  • Arm B: Standard Treatment — OTHER
    Ineligible for RT omission on study; includes management of MRI-detected lesions.

Study Details

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.

Key Dates

Start date
Jun 6, 2025
Status verified
Jan 2026
Primary completion
Jun 30, 2032
Completion
Jun 30, 2039

Study Design

Enrollment
1,400 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER

Arms

  • Experimental: Radiotherapy Omission
    Participants with nil, minimal or mild parenchymal enhancement on pre-operative MRI whose pathology meets inclusion/exclusion requirements for omission of post-operative radiotherapy will be allocated to Arm A, unless the participant prefers to receive Standard Treatment (Arm B) or following clinical team recommendation. Arm A participants will be divided into 2 groups: * Arm A1: Grade 1 or 2/HER2 negative ("low risk") * Arm A2: Grade 3 and/or HER2 positive ("high risk")
  • Active Comparator: Standard Treatment
    Participants who are found to be ineligible for RT omission on study; includes management of MRI-detected lesions. Participants with any of: * Moderate or marked parenchymal enhancement on pre-operative MRI * A malignant occult lesion identified on MRI; or * Pathology that does not meet inclusion/exclusion criteria will receive standard multidisciplinary team recommendations to guide treatment. Participants may also be included in Arm B due to their own preference or following clinical team recommendation.

Primary Outcome Measure

Ipsilateral Invasive Recurrence Rate (IIRR) in low-risk patients omitting RT at a median of 5 years follow up [ Time Frame: Median of 5 years follow up (when 300th low risk patient in Arm A reaches 5 years follow up) ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
UCSF Breast Care CenterSan FranciscoCalifornia94158
Michael Alvarado, Prof
[email protected]
+1 (415) 353-7070
Michael Alvarado, Prof (PRINCIPAL_INVESTIGATOR)
Baylor St Luke's Medical CentreHoustonTexas77030
Alastair Thompson, Prof
[email protected]
+1 (713) 798 2901
Alastair Thompson, Prof (PRINCIPAL_INVESTIGATOR)

Find similar trials in San Francisco, CA

By condition
Breast cancer
By specialty
OncologyBreast oncologyWomen's health
By research site
UCSF Breast Care Center· San Francisco, CABaylor St Luke's Medical Centre· Houston, TX

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