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

NCT06055881 | Recruiting

• 3 other identifiers: GMROR2232NCI-2023-0320822-002943
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 2

Brief 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

Conditions

Breast Carcinoma; Anatomic Stage IV Breast Cancer AJCC v8; Metastatic Breast Cancer

Outcome Measures

Primary Outcomes (1)

• Freedom from a change in systemic therapy (FCST) - overall

  FCST is defined as no change in systemic therapy at 6 months after radiotherapy and patient survival at 6 months after radiotherapy. Treatment failure would indicate that there is no longer stability of systemic therapy (and thereby requires a change in systemic therapy to a different agent).

  6 months

Secondary Outcomes (6)

• Freedom from a change in systemic therapy (FCST) - ER+/PR±/HER2- (Subgroup A)

  6 months

• Freedom from a change in systemic therapy (FCST) - HER2 (Subgroup B)

  6 months

• Progression-free survival (PFS)

  Up to 5 years

• Overall survival (OS)

  Up to 5 years

• Quality of life - EQ-5D-5L

  Up to 5 years

Study Arms (1)

Metastatic Breast Cancer

EXPERIMENTAL

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).

Procedure: Biospecimen Collection; Other: Surveys; Radiation: Stereotactic Body Radiation Therapy (SBRT); Procedure: Computed Tomography; Procedure: Magnetic Resonance Imaging; Procedure: Positron Emission Tomography

Interventions

Biospecimen Collection PROCEDURE

Undergo blood sample collection

Also known as: Biological Sample Collection, Biospecimen Collected, Blood Sample Collection

Metastatic Breast Cancer

Surveys OTHER

Patients complete the European Quality of Life 5 Dimensions 5 Level Version (EQ-5D-5L) survey and "Was it Worth It" questionnaire.

Metastatic Breast Cancer

Stereotactic Body Radiation Therapy (SBRT) RADIATION

Patients receive stereotactic body radiation therapy (SBRT), metastasis-directed radiation therapy .

Also known as: SABR, SBRT, Stereotactic Ablative Body Radiation Therapy, stereotactic body radiation therapy

Metastatic Breast Cancer

Computed Tomography PROCEDURE

Undergo CT, MRI and/or PET/CT

Also known as: CAT, CAT Scan, Computed Axial Tomography, Computerized Axial Tomography, Computed Tomography (CT) scan, CT

Metastatic Breast Cancer

Magnetic Resonance Imaging PROCEDURE

Undergo CT, MRI and/or PET/CT

Also known as: Magnetic Resonance Imaging (MRI), MRI, Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance, MR, MRI Scan, Nuclear Magnetic Resonance Imaging, NMRI, Structural MRI, sMRI

Metastatic Breast Cancer

Positron Emission Tomography PROCEDURE

Undergo CT, MRI and/or PET/CT

Also known as: Medical Imaging, Positron Emission Tomography, PET, Pet Scan, proton magnetic resonance spectroscopic imaging, PT

Metastatic Breast Cancer

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (2)

Mayo Clinic in Arizona

Scottsdale, Arizona, 85259, United States

RECRUITING

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

RECRUITING

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Surveys and Questionnaires; Radiosurgery; Magnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health; Radiotherapy; Therapeutics; Stereotaxic Techniques; Neurosurgical Procedures; Surgical Procedures, Operative; Spectrum Analysis; Chemistry Techniques, Analytical

Study Officials

• Roman O. Kowalchuk, MD

  Mayo Clinic in Rochester

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Clinical Trials Referral Office

CONTACT

855-776-0015; mayocliniccancerstudies@mayo.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 20, 2023
• First Posted: September 28, 2023
• Study Start: October 23, 2023
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): May 1, 2032
• Last Updated: February 6, 2026

Record last verified: 2026-02

Locations

US (2)