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Not yet recruitingLast updated: 29 May 2026

AVATAR II: Testing whether adding radiation therapy to ongoing treatment can delay the need to switch to a new type of treatment for people with advanced ER+, HER2- breast cancer that has become oligoprogressiveStereotactic 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

Trial purpose

Medical clipboardCancer treatment

Tumor type

Breast Cancers Breast

Age

People18+

Trial acronym

AVATAR II

Clinical summary

Summary

The study is testing whether a targeted form of radiation therapy called SABR (Stereotactic Ablative Radiotherapy) can help control the growing spots of cancer, so people can stay on their current treatment for longer.

Who is it for?
You may be eligible for this study if you have advanced breast cancer that is ER-positive and HER2-negative.You should also have been on hormone therapy plus a CDK4/6 inhibitor, and have had your cancer controlled for at least 6 months. You should now have a small number of areas where the cancer has started growing (called oligoprogressive).

Study details
Eligible participants are randomly placed (by chance) into one of two groups:

  • Group A: continue their current hormone therapy and CDK4/6 inhibitor (a targeted cancer medicine) and receive SABR to treat the areas where the cancer is growing.
  • Group B: stop their current treatment and start a new treatment chosen by their doctor.

All participants will be followed up for 3 years after the last participant has been randomised.

Conditions

This trial is treating people with oligoprogressive ER+, HER2- advanced breast cancer who are receiving hormone therapy in combination with a CDK4/6 inhibitor

Eligibility

Inclusion

Patients will be eligible for inclusion in this trial if all the following criteria apply:

  1. Patient has signed the AVATAR-II Patient Information and Consent Form (PICF)
  2. Male or female, ≥ 18 years of age at the time signing consent
  3. Patients with histologically proven ER-positive, HER2-negative advanced breast cancer receiving an ET in combination with a CDK 4/6 inhibitor. Biopsy of metastatic disease if technically feasible but not mandatory
  4. Patients must have evidence of extracranial metastatic disease, with no evidence of uncontrolled intracranial metastases. (Controlled intracranial metastases are defined as stable disease on repeat CT imaging performed at least one month apart.)
  5. Patients must have evidence of radiological response to ET and CDK 4/6 inhibitor for a minimum of six months prior to randomisation (defined as either stable disease or partial response).

    Note: Patient must have ongoing stability/response in at least one lesion at the time of randomisation.

  6. Evidence of new or existing OPD, as determined by the Investigator and defined according to RECIST1.1 (33), via CT on a per-lesion basis (between 1-5 metastases, including the primary) as follows:

    • At least a 20% increase in the diameter of a lesion, taking as reference the smallest diameter on a previous CT scan with an absolute increase of at least 5mm
    • Appearance of a new lesion(s) Note: A new lesion can be identified using various imaging modalities, such as PET-CT or WBBS, as long as the lesion is visible on serial CT scans.
  7. For patients with liver or lung metastases, maximum of 3 oligoprogressive lesions in single organ
  8. All OPD must be amenable to SABR, as per the radiotherapy guidelines in section 11.1 and Appendix 4 and 5
  9. ECOG performance status 0-2
  10. Life expectancy ≥ 6 months
  11. Clinician and patient are willing to continue current line of therapy
  12. Patient is able to complete QoL questionnaires, and other assessments required as part of the study

Exclusion

Patients will not be eligible for inclusion in this trial if any of the following criteria apply:

  1. Is pregnant or lactating at the time of randomisation
  2. Evidence of more than one clone of metastatic disease e.g., a patient with both ER-positive and triple negative clones of disease And ER-negative and/or HER2-positive disease would be excluded from the study
  3. Evidence of leptomeningeal disease
  4. Evidence of malignant cord compression
  5. Evidence of lesion within femoral bone requiring surgical fixation
  6. Patients with risk of bone fracture are not candidate for SABR (Appendix 4 and 5)
  7. Previous chemotherapy for metastatic disease Note: chemotherapy for primary breast cancer is allowed
  8. Contraindications to radiotherapy
  9. Any condition deeming the patient unsuitable to comply with the study
  10. Substantial overlap with previously treated area. Reirradiation is permitted with the condition that the combined plan adheres to the specific dose constraints outlined in this protocol. It is advised to use biological effective dose (BED) calculations to correlate previous doses with the tolerance doses documented in the protocol
  11. Evidence of progression in more than 5 lesions
  12. Prior SABR delivered for oligoprogressive disease with the intent of delaying a change in systemic therapy.

Inclusion

  • Your cancer has spread to other parts of the body (metastatic) or has grown into nearby parts of the body (locally advanced).
  • You have had treatment but your cancer has gotten worse or has not responded to the treatment you have been given.
  • You are currently receiving treatment for your cancer.
  • You have had a certain type of treatment or surgical procedure.

Exclusion

  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
Message

Clinical trials have complex eligibility criteria, and other criteria may apply for this trial. Ask your doctor about whether this trial could be right for you.

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More information

Trial Identifiers

Information on this page is partially produced from ClinicalTrials.gov *. View further details about this trial on the registry via the links below:

Trial sponsor

Peter MacCallum Cancer Centre, Australia

Scientific Title

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

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