Stereotactic Radiotherapy for Oligoprogressive ER-positive Breast Cancer. AVATAR.

Phase 2

Active, not recruiting

• Conditions: Breast Cancer; Cancer - Breast; ER-positive, HER2-negative advanced breast cancer; Advanced breast cancer

• Registration Number: ACTRN12620001212943
• Lead Sponsor: Peter Mac Callum Cancer Centre

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-11-16
• Last Update Posted: 27 February 2023

Recruitment & Eligibility

• Status: Active, not recruiting
• Sex: All
• Target Recruitment: 32

Inclusion Criteria

1.Male or female, 18 years of age or older
2.Patients with histologically proven ER-positive, HER2-negative advanced breast cancer receiving an AI in combination with a CDK 4/6 inhibitor. Biopsy of metastatic disease if technically feasible but not mandatory.
3.Patients must have evidence of extracranial metastatic disease with or without intracranial metastases.
4.Radiological evidence of stable or responding disease to an AI in combination with a CDK 4/6 inhibitor for a period of at least 6 months prior to study entry. (Patient must have ongoing stability/response in at least one lesion at the time of registration).
5.Evidence of new or existing OPD in 1-5 lesions. With reference to RECIST 1.132 and or PERCIST 1.033, OPD is defined as follow:
a.Using CT for intracranial or extracranial OPD:
i.greater than 5 mm increase in the diameter of an existing lesion OR
ii.more than 20% increase in the diameter of an existing lesion on 2 consecutive imaging studies at least 2 months apart OR
iii.The appearance of one or more new soft tissue lesions, measuring more than 5 mm.
b.Using Positron Emission Tomography for extracranial OPD:
i.greater than 30% increase in 18F-FDG SUV peak, with more than 0.8 SUV units increase in tumour SUV from the baseline scan in pattern typical of tumour and not of infection/treatment effect OR
ii.New 18F-FDG avid lesions typical of cancer (including new bone lesion) and not related to treatment effect and/or infection.
6.For patients with liver or lung metastases, maximum of 3 oligoprogressive lesions in single organ.
7.All OPD must be amenable to SRT.
a.Patients with risk of bone fracture are not candidate for SRT
8.For patients with intracranial metastases, SRT is the preferred treatment option, however, if clinical assessment indicated that upfront surgery is better, then post-operative SRT to the surgical cavity is recommended.
9.ECOG performance status 0-2.
10.Life expectancy of greater than 6 months.
11.Provision of written informed consent.
12.Clinician and participant are willing to continue current line of therapy.

Exclusion Criteria

1.Pregnancy or lactation at the time of study entry.
2.Evidence of more than one clone of metastatic disease e.g. ER-positive and ER-negative and or HER2-positive disease. (To exclude those with some ER-positive and some TNBC or HER2-positive disease).
3.Evidence of Leptomeningeal disease.
4.Evidence of Malignant cord compression.
5.Previous chemotherapy for metastatic disease (chemo for primary breast cancer is allowed).
6.Contraindication to radiotherapy.
7.Previous radiotherapy in which the treated area planned to receive treatment is greater or equal to EQD2 40 Gy.
8.Any condition deeming the patient unsuitable to comply with the study.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary outcome of this study is to measure time to change or cessation of systemic therapy (AI + CDK 4/6 inhibitor), defined as the time from commencement of stereotactic radiotherapy to change in systemic therapy.. This outcome will be assessed by treating physician at patient visit .[Assessed every 3 months for two years after the completion of treatment.<br><br>]

Secondary Outcome Measures

Name	Time	Method
Measure Progression free survival which will be assessed each three months from date of commencement of SRT to date of first evidence of progression or death by any cause. This will be assessed by data linkage to medical records.<br>[Assessed every three months for two years following completion of treatment];overall survival and treatment related toxicity[overall survival and treatment toxicity assessed every three months from date of commencement of SRT to date of death by any cause, assessed by data-linkage to medical records.];Safety will be assessed using CTCAE v5.0 and the maximum toxicity grade, per patient of each adverse event will be derived'. [Assessed every three months for two years following completion of treatment.]