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

NCT ID: NCT06925984

Last Updated: 2026-01-21

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-10-30
• Study Completion Date: 2030-05-01

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 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.

Conditions

OligoProgressive Metastatic Disease

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

SBRT on the oligoprogressive metastases. Continuation of same systemic therapy.

Group Type: EXPERIMENTAL

SBRT

Intervention Type: RADIATION

SBRT of all oligoprogressive metastases (or other local therapy if SBRT not advisable), followed by continuation of the same systemic therapy.

Interventions

SBRT

SBRT of all oligoprogressive metastases (or other local therapy if SBRT not advisable), followed by continuation of the same systemic therapy.

Intervention Type: RADIATION

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Jules Bordet Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Jules Bordet Institute

Brussels, , Belgium

Site Status: RECRUITING

UZ Gent

Ghent, , Belgium

Site Status: NOT_YET_RECRUITING

AZ Groeninge

Kortrijk, , Belgium

Site Status: NOT_YET_RECRUITING

AZ Sint-Maarten

Mechelen, , Belgium

Site Status: RECRUITING

CHU UCL Namur - Site Saint Elisabeth

Namur, , Belgium

Site Status: RECRUITING

Countries

Belgium

Central Contacts

Robbe Van den Begin, MD PhD

Role: CONTACT

robbe.vandenbegin@hubruxelles.be

+32 2 541 38 28

Facility Contacts

Alex De Caluwé, MD

Role: primary

alex.decaluwe@hubruxelles.be

+32 2 541 38 28

Liv Veldeman, MD PhD

Role: primary

+32 9 332 30 15

Isabelle Kindts, MD PhD

Role: primary

radiotherapie@azgroeninge.be

+32 56 63 39 03

Alex De Caluwé, MD

Role: primary

azsintmaarten@emmaus.be

+32 15 89 29 80

Vincent Remouchamps, MD PhD

Role: primary

sormn.se@chuuclnamur.uclouvain.be

+32 81 72 05 25

Other Identifiers

CE4005

Identifier Type: -

Identifier Source: org_study_id