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New treatment option for OligoProgressive Metastatic Disease
Official title Stereotactic Radiotherapy for Oligoprogressive ER+/HER- Metastatic Breast Cancer, a Prospective Phase 2 Study (Oligopro-Breast)
ClinicalTrials.gov ID: NCT06925984
What this study is testing
- What it's testing
- 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.
- Time commitment: about 12 months
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, women only
You may be able to join if
- 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...
- 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.
You likely can't join if
- 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...
- Inability to continue the same ST line after local therapy (for example because of toxicity or patient refusal).
- Pregnancy.
See the full eligibility 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.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Brussels, Belgium
- Ghent, Belgium
- Kortrijk, Belgium
- Mechelen, Belgium
- Namur, Belgium
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 12 months per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling female, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Brussels, Belgium; Ghent, Belgium; Kortrijk, Belgium; Mechelen, Belgium; Namur, Belgium. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.