전신 요법의 유지와 의사의 올리고 프로토리 ER- 양성, HER-2 음성 유방암 II에 대한 전신 요법 선택을 갖는 전형적인 절제 신체 방사선 요법 (SABR) (AVATARII)
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.
연구 개요
상태
상세 설명
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.
All patients will be followed up for 3 years after the last patient has been randomised.
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: A/Prof Steven David
- 전화번호: +61 3 9928 9801
- 이메일: steven.david@petermac.org
연구 연락처 백업
- 이름: A/Prof Michelle White
- 전화번호: +61 3 9928 8111
- 이메일: michelle@mcc.net.au
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
INCLUSION CRITERIA
Patients will be eligible for inclusion in this trial if all the following criteria apply:
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Patient has signed the AVATAR-II Patient Information and Consent Form (PICF)
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Male or female, ≥ 18 years of age at the time signing consent
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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
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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.)
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Patients must have evidence of radiological response to ET and CDK 4/6 inhibitor for a minimum of six months prior to randomisation.
Note: Patient must have ongoing stability/response in at least one lesion at the time of randomisation.
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Evidence of new or existing OPD, as determined by the Investigator and defined according to RECIST1.1, 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.
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For patients with liver or lung metastases, maximum of 3 oligoprogressive lesions in single organ
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All OPD must be amenable to SABR, as per the radiotherapy guidelines in section 11.1 and Appendix 4 and 5 of Protocol v2.3 dated 20Feb2026
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ECOG performance status 0-2
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Life expectancy ≥ 6 months
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Clinician and patient are willing to continue current line of therapy if randomised to Arm A
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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:
- Is pregnant or lactating at the time of randomisation
- 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
- Evidence of leptomeningeal disease
- Evidence of malignant cord compression
- Evidence of lesion within femoral bone requiring surgical fixation
- Patients with risk of bone fracture are not candidate for SABR (Appendix 4 and 5 of Protocol v2.3 dated 20Feb2026)
- Previous chemotherapy for metastatic disease. Note: chemotherapy for primary breast cancer is allowed
- Contraindications to radiotherapy
- Any condition deeming the patient unsuitable to comply with the study
- 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
- Evidence of progression in more than 5 lesions
- Prior SABR delivered for oligoprogressive disease with the intent of delaying a change in systemic therapy.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: 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 |
Stereotactic Ablative Radiotherapy |
|
활성 비교기: 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 |
Physician's choice of systemic therapy does not mandate a change in systemic therapy, however, SABR is not permitted for management in this arm |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Primary Outcome Measure
기간: 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.
|
The primary endpoint of this study is to measure the time to treatment failure between Arm A and Arm B. Treatment failure is defined as time from randomisation to progression of disease resulting in a failure of treatment strategy or death by any cause. Progression, will be determined by the Investigator, using the Response Evaluation Criteria in Solid Tumors, Version 1.1. (RECIST1.1; Appendix 2) (33) as a guide. The treatment strategy in Arm A is to maintain patients on current ET 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 systemic therapy alone. |
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.
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Secondary Objective 1
기간: 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.
|
To compare PFS; PFS is assessed from randomisation to the date of the first evidence of progression or death by any cause. Progression will be assessed by the treating clinician as part of standard-of-care practice, using RECIST 1.1 as a guide or based on clinical progression. |
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.
|
|
Secondary Objective 2
기간: 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.
|
To compare progression-free survival 2 (PFS-2); PFS-2 is assessed from randomisation to the date of progression on next line of systemic anti-cancer treatment or death by any cause. |
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.
|
|
Secondary Objective 3
기간: 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.
|
To compare PFS of next line of treatment (2nd PFS); 2nd PFS is assessed from failure of treatment strategy to progression on next line of systemic anti-cancer treatment or date of death by any cause. |
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.
|
|
Secondary Objective 4
기간: 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.
|
To compare OS; OS is assessed from randomisation to the date of death by any cause. |
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.
|
|
Secondary Objective 5
기간: 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.
|
To compare treatment related adverse events (TRAEs); TRAEs are adverse events assessed using the Common Terminology for Adverse Events Version 5.0 (CTCAE v5.0) considered possibly, probably, or definitely related to treatment (systemic therapy or SABR) |
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.
|
|
Secondary Objective 6
기간: 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.
|
To compare the QoL using the FACT-B total score: Area under the curve (AUC) of the FACT-B Total score from baseline to 48 weeks |
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.
|
공동 작업자 및 조사자
수사관
- 수석 연구원: A/Prof Steven David, Peter MacCallum Cancer Centre, Australia
간행물 및 유용한 링크
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연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- PMC105165 (24/143)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
Not contractually obliged but it may be considered
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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