Radioterapia del corpo ablativo stereotassico (SABR) con mantenimento della terapia sistemica rispetto alla scelta della terapia sistemica da parte dei medici per ER-positivo oligoprorogressivo, carcinoma mammario HER-2 II (AVATARII)
15 settembre 2026 aggiornato da: Peter MacCallum Cancer Centre, Australia
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.
Panoramica dello studio
Stato
Stato
Non ancora reclutamento
Condizioni
Condizioni
Intervento / Trattamento
Intervento / Trattamento
Descrizione dettagliata
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.
Tipo di studio
Tipo di studio
Interventistico
Iscrizione (Stimato)
Iscrizione
74
Fase
Fase
- Non applicabile
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Contatto studio
Contatto studio
- Nome: A/Prof Steven David
- Numero di telefono: +61 3 9928 9801
- Email: steven.david@petermac.org
Backup dei contatti dello studio
- Nome: A/Prof Michelle White
- Numero di telefono: +61 3 9928 8111
- Email: michelle@mcc.net.au
Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Criteri di ammissibilità
Età idonea allo studio
18 anni e precedenti (Adulto, Adulto più anziano)
Accetta volontari sani
No
Sessi ammissibili allo studio
Tutto
Descrizione
INCLUSION CRITERIA
Patients will be eligible for inclusion in this trial if all the following criteria apply:
-
Patient has signed the AVATAR-II Patient Information and Consent Form (PICF)
-
Male or female, ≥ 18 years of age at the time signing consent
-
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
-
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.)
-
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.
-
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.
-
For patients with liver or lung metastases, maximum of 3 oligoprogressive lesions in single organ
-
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
-
ECOG performance status 0-2
-
Life expectancy ≥ 6 months
-
Clinician and patient are willing to continue current line of therapy if randomised to Arm A
-
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.
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Nessuno (etichetta aperta)
Numero di armi
2
Armi e interventi
Gruppo di partecipanti / ArmGruppo di partecipanti / Arm |
Intervento / TrattamentoIntervento / Trattamento |
|---|---|
|
Sperimentale: 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 |
|
Comparatore attivo: 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 |
Cosa sta misurando lo studio?
Misure di risultato primarie
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Primary Outcome Measure
Lasso di tempo: 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.
|
Misure di risultato secondarie
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Secondary Objective 1
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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.
|
Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Sponsor
Sponsor
Investigatori
Investigatori
- Investigatore principale: A/Prof Steven David, Peter MacCallum Cancer Centre, Australia
Pubblicazioni e link utili
La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.
Pubblicazioni generali
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Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio (Stimato)
Inizio studio
1 novembre 2026
Completamento primario (Stimato)
Completamento primario
1 novembre 2032
Completamento dello studio (Stimato)
Completamento dello studio
1 novembre 2032
Date di iscrizione allo studio
Primo inviato
Primo inviato
8 dicembre 2024
Primo inviato che soddisfa i criteri di controllo qualità
Primo inviato che soddisfa i criteri di controllo qualità
12 marzo 2025
Primo Inserito (Effettivo)
Primo Inserito
18 marzo 2025
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento pubblicato
18 settembre 2026
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo aggiornamento inviato che soddisfa i criteri QC
15 settembre 2026
Ultimo verificato
Ultimo verificato
1 settembre 2026
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
Altri numeri di identificazione dello studio
- PMC105165 (24/143)
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
NO
Descrizione del piano IPD
Not contractually obliged but it may be considered
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
No
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
No
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