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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

Study acronym: AVATARII
StatusNot Yet Recruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 4 months later Jun 2032 → Nov 1, 2032
See other at-risk trials from Peter MacCallum Cancer Centre, Australia

Record History

See every version on ClinicalTrials.gov ↗

  1. Start date: Jun 2026 to Nov 1, 2026 Show 6 more changesShow less
    • Primary and study completion pushed from Jun 2032 to Nov 1, 2032
    • Interventions: Physician's choice of systemic treatment (Other), Stereotactic Ablative Radiotherapy (Radiation) to Physician's choice of systemic treatment (Other), Stereotactic Ablative Radiotherapy (Radiation)
    • Eligibility criteria expanded, about 32 words
    • Secondary endpoints: details revised at 1 of 6 entries
    • Study description shortened, about 8 words
    • Publications: 32 to 33
  2. Start date: May 1, 2025 to Jun 2026v2 Show 4 more changesShow less
    • Primary and study completion dates: Feb 2032 to Jun 2032
    • Eligibility criteria expanded, about 43 words
    • Secondary endpoints: details revised at 1 of 6 entries
    • Collaborators shortened, about 5 words
  3. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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 treatment failure (TTF) 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.
Trial Details
NCT Number NCT06882499
Lead Sponsor Peter MacCallum Cancer Centre, Australia
Conditions
(from sponsor)		 Breast Cancer, Metastatic, Metastatic Breast Cancer
Related terms Breast Neoplasms, Neoplasm Metastasis
Enrollment 74 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov