Status:
RECRUITING
Stereotactic Radiotherapy for Oligoprogressive ER+/HER- Metastatic Breast Cancer, a Prospective Phase 2 Study (Oligopro-Breast)
Lead Sponsor:
Jules Bordet Institute
Conditions:
OligoProgressive Metastatic Disease
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief Summary
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 progre...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 30 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2030
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT06925984
Start Date
October 30 2025
End Date
May 1 2030
Last Update
December 9 2025
Active Locations (5)
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1
Jules Bordet Institute
Brussels, Belgium
2
UZ Gent
Ghent, Belgium
3
AZ Groeninge
Kortrijk, Belgium
4
AZ Sint-Maarten
Mechelen, Belgium