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
NCT ID: NCT06882499
Last Updated: 2025-03-18
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
NOT_YET_RECRUITING
Clinical Phase
NA
Total Enrollment
74 participants
Study Classification
INTERVENTIONAL
Study Start Date
2025-05-01
Study Completion Date
2032-02-29
Brief Summary
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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.
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.
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Detailed Description
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AVATAR II is a phase II multicentre open label, randomised trial. Following informed consent, eligible patients with ER-positive, HER2-negative advanced breast cancer receiving an ET (either AI or selective estrogen receptor degrader in combination with a CDK 4/6 inhibitor with newly diagnosed OPD amenable to SABR will be randomised to either:
Arm A: SABR to all known sites of OPD with continuation of first line therapy ET and CDK 4/6 inhibitor Arm B: Physician's choice of systemic treatment
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).
All patients will be followed up for 3 years after the last patient has been randomised.
Arm A: SABR to all known sites of OPD with continuation of first line therapy ET and CDK 4/6 inhibitor Arm B: Physician's choice of systemic treatment
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).
All patients will be followed up for 3 years after the last patient has been randomised.
Conditions
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Breast Cancer, Metastatic
Metastatic Breast Cancer
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Primary Study Purpose
TREATMENT
Blinding Strategy
NONE
Study Groups
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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
Group Type
EXPERIMENTAL
Stereotactic Ablative Radiotherapy
Intervention Type
RADIATION
Stereotactic Ablative Radiotherapy
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
Group Type
ACTIVE_COMPARATOR
Physician's choice of systemic treatment
Intervention Type
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
Interventions
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Stereotactic Ablative Radiotherapy
Stereotactic Ablative Radiotherapy
Intervention Type
RADIATION
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
Intervention Type
OTHER
Eligibility Criteria
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Inclusion Criteria
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
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 5 mm
* 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
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
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 5 mm
* 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 Criteria
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 below
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 below
Minimum Eligible Age
18 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Monash Health
OTHER
Sponsor Role
collaborator
Monash Medical Centre
OTHER
Sponsor Role
collaborator
Peter MacCallum Cancer Centre, Australia
OTHER
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Principal Investigators
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A/Prof Steven David
Role: PRINCIPAL_INVESTIGATOR
Peter MacCallum Cancer Centre, Australia
Central Contacts
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References
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Alomran R, White M, Bruce M, Bressel M, Roache S, Karroum L, Hanna GG, Siva S, Goel S, David S. Stereotactic radiotherapy for oligoprogressive ER-positive breast cancer (AVATAR). BMC Cancer. 2021 Mar 23;21(1):303. doi: 10.1186/s12885-021-08042-w.
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David SP, Siva S, Bressel M, Tan J, Hanna GG, Alomran RK, et al. Stereotactic Ablative Body Radiotherapy (SABR) for Oligoprogressive ER-Positive Breast Cancer (AVATAR): A Phase II Prospective Multicenter Trial. International journal of radiation oncology, biology, physics. 2023;117(4):e6-e.
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Other Identifiers
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PMC105165 (24/143)
Identifier Type: -
Identifier Source: org_study_id
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RECRUITING
PHASE2
Open-label, Single Center, Single-arm, Phase 2 Study of Neoadjuvant Pembrolizumab in Combination With Carboplatin and Paclitaxel in Patients With Stage 1 cT1b-T1cN0M0 Triple Negative Breast Cancer
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RECRUITING
PHASE2
Olaparib and Durvalumab in Treating Participants With Metastatic Triple Negative Breast Cancer
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COMPLETED
PHASE1
Study of Neoadjuvant Olaparib Monotherapy and Olaparib and Durvalumab Combination in HER2 Negative BRCAm Breast Cancer
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ACTIVE_NOT_RECRUITING
PHASE2
Radiation Therapy, Palbociclib, and Hormone Therapy in Treating Breast Cancer Patients With Bone Metastasis
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COMPLETED
PHASE2
Radiation Therapy Followed by Intrathecal Trastuzumab/Pertuzumab in HER2+ Breast Leptomeningeal Disease
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RECRUITING
PHASE1/PHASE2
Study to Assess the Efficacy of Pembrolizumab Plus Radiotherapy in Metastatic Triple Negative Breast Cancer Patients
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COMPLETED
PHASE2