Stereotactic Radiotherapy for Oligoprogressive ER+/HER- Metastatic Breast Cancer, a Prospective P… (NCT06925984) | Clinical Trial Compass
RecruitingNot Applicable
Stereotactic Radiotherapy for Oligoprogressive ER+/HER- Metastatic Breast Cancer, a Prospective Phase 2 Study (Oligopro-Breast)
Belgium48 participantsStarted 2025-10-30
Plain-language 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 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 of resistant metastases can prolong the effectiveness of ongoing systemic therapy, which is particularly beneficial if the treatment is well-tolerated. The primary objective is to measure the proportion of patients surviving without changing their systemic treatment line at 6 months after SBRT.
This trial is significant for patients as it explores a method to potentially extend the duration of effective and well-tolerated treatments, offering hope for better management of metastatic breast cancer.
Who can participate
Age range
18 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.