Primary Breast Oligoprogressive Sites Treated with Radiotherapy to Obviate the Need to Change Systemic Therapy

Description

This study assesses if metastasis-directed radiation therapy (Stereotactic body radiation therapy - SBRT) can delay a change in systemic therapy, and if circulating tumor cells in the bloodstream can help guide treatment options in metastatic breast cancer patients with progressive disease

Conditions

Breast Carcinoma, Anatomic Stage IV Breast Cancer AJCC V8, Metastatic Breast Cancer

Study Overview

Study Details

Study overview

This study assesses if metastasis-directed radiation therapy (Stereotactic body radiation therapy - SBRT) can delay a change in systemic therapy, and if circulating tumor cells in the bloodstream can help guide treatment options in metastatic breast cancer patients with progressive disease

Primary Breast Oligoprogressive Sites Treated with Radiotherapy to Obviate the Need to Change Systemic Therapy (BOSS)

Primary Breast Oligoprogressive Sites Treated with Radiotherapy to Obviate the Need to Change Systemic Therapy

Condition
Breast Carcinoma
Intervention / Treatment

-

Contacts and Locations

Scottsdale

Mayo Clinic in Arizona, Scottsdale, Arizona, United States, 85259

Rochester

Mayo Clinic in Rochester, Rochester, Minnesota, United States, 55905

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • * 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.
  • * 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.
  • * 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
  • * \> 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.

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

FEMALE

Accepts Healthy Volunteers

No

Collaborators and Investigators

Mayo Clinic,

Roman O. Kowalchuk, MD, PRINCIPAL_INVESTIGATOR, Mayo Clinic in Rochester

Study Record Dates

2025-10-30