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

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Procedure, Other, Radiation
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

• 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.

Locations
United States
Arizona
Mayo Clinic in Arizona
RECRUITING
Scottsdale
Minnesota
Mayo Clinic in Rochester
RECRUITING
Rochester
Contact Information
Primary
Clinical Trials Referral Office
mayocliniccancerstudies@mayo.edu
855-776-0015
Time Frame
Start Date: 2023-10-23
Estimated Completion Date: 2026-10-30
Participants
Target number of participants: 45
Treatments
Experimental: Metastatic Breast Cancer
Breast cancer patients with ER+/PR± (any PR status)/HER2- disease or HER2+ disease (any ER or PR status) will receive radiotherapy that consists primarily of Stereotactic body radiation therapy (SBRT), but at a minimum, it will consist of dose-escalated, moderately hypofractionated radiotherapy (as opposed to conventional fractionation or conventional palliative treatment regimens).
Related Therapeutic Areas
Sponsors
Leads: Mayo Clinic

This content was sourced from clinicaltrials.gov