Stereotactic Ablative Body Radiotherapy (SABR) With Maintenance of Systemic Therapy Versus Physicians' Choice of Systemic Therapy for Oligoprogressive ER-positive, Her-2 Negative Breast Cancer II

Sponsor
Peter MacCallum Cancer Centre, Australia
Study ID
NCT06882499
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Stereotactic Ablative Radiotherapy — RADIATION
    Stereotactic Ablative Radiotherapy
  • Physician's choice of systemic treatment — OTHER
    Physician's choice of systemic therapy does not mandate a change in systemic therapy, however, SABR is not permitted for management in this arm

Study Details

The goal of this clinical trial is to assess Stereotactic Ablative Radiotherapy (SABR) as a method to delay a change in systemic therapy in patients with oligoprogressive ER-positive, HER2-negative advanced breast cancer. The main question it aims to answer is to assess whether the addition of SABR to continuation of first line endocrine therapy and CDK 4/6 inhibitor (Arm A) to patients with oligoprogressive ER-positive, HER2-negative advanced breast cancer could have longer time to strategy failure (TSF) in comparison to physician choice of systemic treatment (Arm B) in patients who had progressed first line. The treatment strategy in Arm A is to maintain patients on current endocrine therapy and CDK 4/6 inhibitor, controlling localised progressing sites of disease with SABR. Treatment strategy in Arm B is to maintain disease control with physician's choice of systemic therapy alone.

Key Dates

First listed
Mar 18, 2025
Start date
Jun 30, 2026
Status verified
Mar 2026
Primary completion
Jun 30, 2032
Completion
Jun 30, 2032

Study Design

Enrollment
74 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: SABR to all known sites of oligoprogressive disease with continuation of first line therapy
    SABR to all known sites of oligoprogressive disease with continuation of first line therapy ET + CDK4/6i
  • Active Comparator: Physician's choice of systemic treatment
    Physician's choice of systemic treatment does not mandate a change in systemic therapy, however, SABR is not permitted for management in this arm

Primary Outcome Measure

Primary Outcome Measure [ Time Frame: Time from randomisation to progression of disease resulting in a failure of treatment strategy or death by any cause assessed until withdrawal of consent, death, or 3 years after the last patient has been randomised, whichever is earlier. ]

Central Contacts

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