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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

NCT06882499 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 74

Last updated 2026-04-02

No results posted yet for this study

Summary

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.

Conditions

Interventions

RADIATION

Stereotactic Ablative Radiotherapy

Stereotactic Ablative Radiotherapy

OTHER

Physician's choice of systemic treatment

Physician's choice of systemic therapy does not mandate a change in systemic therapy, however, SABR is not permitted for management in this arm

Sponsors & Collaborators

  • Peter MacCallum Cancer Centre, Australia

    lead OTHER

Principal Investigators

  • A/Prof Steven David · Peter MacCallum Cancer Centre, Australia

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-06-30
Primary Completion
2032-06-30
Completion
2032-06-30

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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 NCT06882499 on ClinicalTrials.gov