Stereotactic radiotherapy for limited progression in ER+/HER2- metastatic breast cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This prospective Phase II trial enrolls women with ER+/HER2- metastatic breast cancer who have been on endocrine therapy and/or CDK4/6 inhibitors for at least six months and now have progression at 1–3 extracranial sites. Eligible progressive lesions will receive stereotactic body radiotherapy (SBRT) or another local ablative treatment if SBRT is not feasible, while patients remain on their current systemic therapy. The protocol allows repeat local treatment for new oligoprogression; a switch to a new systemic line is triggered by intracranial progression, polyprogression (>3 lesions at once), more than six progressing lesions within 12 months, or lesions not amenable to local therapy. The trial aims to determine whether controlling a few resistant metastases locally can prolong the benefit of ongoing endocrine/CDK4/6 therapy.

Why it matters

Who can join: the full rules

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.

Where it's running

• Jules Bordet Institute
  Brussels, Belgium Recruiting
• UZ Gent
  Ghent, Belgium Recruiting
• AZ Groeninge
  Kortrijk, Belgium Recruiting
• AZ Sint-Maarten
  Mechelen, Belgium Recruiting
• CHU UCL Namur - Site Saint Elisabeth
  Namur, Belgium Recruiting

Study contacts

• Study coordinator: Robbe Van den Begin, MD PhD
• Email: robbe.vandenbegin@hubruxelles.be
• Phone: +32 2 541 38 28

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.