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Stereotactic Radiotherapy for Oligoprogressive ER+/HER- Metastatic Breast Cancer, a Prospective Phase 2 Study (Oligopro-Breast)

RecruitingNAAges 18 Years - anyFemaleJules Bordet Institute
NCT06925984 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

The Oligopro-Breast trial is a Phase II study targeting women with ER+/HER2- metastatic breast cancer who have been on endocrine therapy and/or CDK4/6 inhibitors for at least 6 months, and show progressive disease at 1-3 extracranial metastases, which are treatable locally. The trial aims to investigate if treating these resistant metastases with SBRT (or other local treatments if SBRT is not possible) can extend the use of the current systemic therapy. Patients will continue their existing systemic treatment while receiving SBRT on all progressive lesions. If new oligoprogression occurs, SBRT will be performed again. A new systemic treatment line will start if there is polyprogression (more than 3 lesions at once), progression of more than 6 lesions over 12 months, intracranial progression, or lesions that cannot be treated locally. The scientific question is whether local treatment o

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📋 Eligibility rules (as published)
Inclusion Criteria: * ECOG performance status 0-2. * Histologically confirmed ER+/HER2- MBC. * History of polymetastatic disease. Patients with genuine oligometastatic disease and 1-3 oligoprogressive lesions are only allowed if ablative therapy of all metastases is deemed impossible. * Under 1st to 2nd systemic treatment line with hormonotherapy and/or CDK4/6 inhibitors for at least 6 months before progression. * Progressive disease at 1-3 extracranial sites. * Ability to treat all progressive lesions locally according to the treating radiation oncologist. Exclusion Criteria: * Second malignancy if it is not in complete remission. * Previous local treatment for oligoprogression under the current systemic treatment line * Current progression in a lesion that has been treated with SBRT before and is not amendable for surgery or radiofrequency ablation (RFA). * Progressive or newly diagnosed brain metastases. Known brain metastases that have been nonprogressive for at least 6 months, are not an exclusion criterion. * Inability to continue the same ST line after local therapy (for example because of toxicity or patient refusal). * Pregnancy. * Inability to sign the informed consent.
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What it tests

  • SBRT
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Where

5 sites
Jules Bordet Institute
Brussels, Belgium
UZ Gent
Ghent, Belgium
AZ Groeninge
Kortrijk, Belgium
AZ Sint-Maarten
Mechelen, Belgium
CHU UCL Namur - Site Saint Elisabeth
Namur, Belgium
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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