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Radiation Therapy for the Treatment of Patients with Metastatic Breast Cancer with Disease Progression at a Limited Number of Sites, BOSS Trial
Trial Status: active
This phase II trial tests how well radiation therapy (stereotactic body radiation therapy [SBRT]), works in treating patients with breast cancer that has spread from where it first started (primary site) to other places in the body (metastatic) and have breast cancer that is growing, spreading, or getting worse (disease progression) at a limited number of sites. SBRT is a type of external radiation therapy that uses special equipment to position a patient and precisely deliver radiation to tumors in the body (except the brain). The total dose of radiation is divided into smaller doses given over several days. This type of radiation therapy helps spare normal tissue. Using SBRT may be effective in treating patients with metastatic breast cancer with disease progression at a limited number of sites and may allow patients to delay changing anticancer drug treatment.
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
Any of the following:
* 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). Patients with ER negative, PR positive, and HER2 negative disease will also be excluded.
Active second primary malignancy.
> 3 extracranial sites of oligoprogressive disease.
Active central nervous system (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.
Additional locations may be listed on ClinicalTrials.gov for NCT06055881.
I. To assess whether radiotherapy can provide clinically significant freedom from a change in systemic therapy (defined as for at least 6 months) for well-selected patients with oligoprogressive metastatic breast cancer.
SECONDARY OBJECTIVES:
I. To assess whether metastasis-directed radiotherapy can result in a clinically significant freedom from a change in systemic therapy (defined as for at least 6 months) for patients with estrogen receptor (ER)+/progesterone receptor (PR)+/human epidermal growth factor receptor 2 (HER2)- disease.
II. To assess whether metastasis-directed radiotherapy can result in a clinically significant freedom from a change in systemic therapy (defined as for at least 6 months) for patients with HER2+ disease.
III. Assess the impact of metastasis-directed radiotherapy on progression-free survival in the setting of oligoprogressive breast cancer.
IV. Explore the impact of metastasis-directed radiotherapy on overall survival in the setting of oligoprogressive breast cancer.
V. Analyze quality of life for patients receiving metastasis-directed radiotherapy for oligoprogressive breast cancer, as determined by patient reported outcomes (PROs).
VI. Determine the local control of irradiated, oligoprogressive lesions.
VII. Assess the safety and tolerability of the treatment by assessment of adverse events.
EXPLORATORY OBJECTIVES:
I. Analyze any clinical circulating tumor deoxyribonucleic acid (ctDNA) results for potential predictive and/or prognostic roles in this patient population, including as a factor for patient selection for metastasis-directed radiotherapy.
II. Assess alternative non-clinical biomarker approaches for predictive and/or prognostic roles in this population using the collected biospecimens.
III. Study immunologic biomarkers of clinical response, as well as immunologic predictors of subsequent treatment response.
IV. Determine whether tumor-derived extracellular vesicles can provide a meaningful prognostic marker for oligoprogressive breast cancer.
OUTLINE:
Patients undergo SBRT to the sites of oligoprogression as clinically indicated on study. Additionally, patients undergo computed tomography (CT), magnetic resonance imaging (MRI) and/or positron emission tomography (PET)/CT as well as blood sample collection throughout the study.
After completion of study treatment, patients are followed up at 2, 12 and 24 weeks and then up to 5 years after completion of radiotherapy.
