Radiation therapy for metastatic breast cancer to delay changing treatments
Primary Breast Oligoprogressive Sites Treated With Radiotherapy to Obviate the Need to Change Systemic Therapy (BOSS)
This study tests if a targeted type of radiation therapy can help people with metastatic breast cancer delay changing their main treatment when they have a few progressing spots.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 45 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Mayo Clinic Academic / other |
| Drugs / interventions | radiation |
| Locations | 2 sites (Scottsdale, Arizona and 1 other locations) |
| Trial ID | NCT06055881 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of stereotactic body radiation therapy (SBRT) in treating patients with metastatic breast cancer who have developed 1-3 oligoprogressive sites. The goal is to determine if this targeted radiation can postpone the need to alter systemic therapy. Additionally, the study will investigate the role of circulating tumor cells in guiding treatment decisions for these patients. Participants will undergo biospecimen collection, imaging, and surveys as part of the assessment.
Who should consider this trial
Good fit: Ideal candidates are adults with metastatic breast cancer who have shown a clinical response to systemic therapy and have developed limited progressive disease.
Not a fit: Patients with extensive metastatic disease or those who have not responded to prior systemic therapies may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could help patients maintain their current systemic therapy longer, potentially improving their quality of life.
How similar studies have performed: While the use of SBRT in oligoprogressive disease is gaining interest, this specific approach is relatively novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria:
* Age ≥ 18 years.
* Histological confirmation of primary breast cancer.
* Patients with metastatic breast cancer and at least 12 months of clinical response to first-line systemic therapy, with the subsequent development of 1-3 extracranial sites of oligoprogressive disease, and who plan for the continuation of the current systemic therapy.
* NOTE: patients with de novo metastatic disease and those developed metastatic disease after initially localized disease can both be included.
OR
* Patients with metastatic breast cancer and at least 6 months of clinical response to second-line systemic therapy (or further, e.g., third- or fourth-line), with the subsequent development of 1-3 extracranial sites of oligoprogressive disease.
* Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) ≤ 2.
* Negative urine or serum pregnancy test done ≤ 7 days prior to registration, for women of childbearing potential only.
* Ability to complete questionnaire(s) by themselves or with assistance.
* Provide written informed consent.
* Willing to return to enrolling institution for follow-up (during the Active Monitoring Phase of the study).
* Willing to provide blood samples for correlative research purposes.
* Receiving radiation therapy as specified in the protocol.
Exclusion Criteria:
* Male patients.
* Nursing or pregnant women.
* Men or women of childbearing potential who are unwilling to employ adequate contraception.
* Patients with triple negative disease (negative for ER, PR, and HER2).
* Active second primary malignancy
* More than 3 extracranial sites of oligoprogressive disease
* Active CNS disease. Patients with asymptomatic and stable, treated CNS lesions (radiation and/or surgery and/or other CNS-directed therapy who have not received corticosteroids for at least 4 weeks) are allowed.
* Active connective tissue disease that is felt by the treatment team to pose an excess risk of toxicity.
* Prior radiation that overlaps with the intended treatment volume such that, in the opinion of the patient's Radiation Oncologist, radiotherapy to progressing sites will not be safe.
* NOTE: patients with some dose overlap with prior radiotherapy that is deemed safe by the patient's Radiation Oncologist can be included in the trial.
Where this trial is running
Scottsdale, Arizona and 1 other locations
- Mayo Clinic in Arizona — Scottsdale, Arizona, United States (Recruiting)
- Mayo Clinic in Rochester — Rochester, Minnesota, United States (Recruiting)
Study contacts
- Principal investigator: Roman O. Kowalchuk, MD — Mayo Clinic in Rochester
- Study coordinator: Clinical Trials Referral Office
- Email: mayocliniccancerstudies@mayo.edu
- Phone: 855-776-0015
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.