A Study on Adding Precisely Targeted Radiation Therapy (Stereotactic Body Radiation Therapy) to the Usual Treatment Approach (Drug Therapy) in People With Breast Cancer

Sponsor
Memorial Sloan Kettering Cancer Center (Other)
Overall Status
Recruiting
CT.gov ID
NCT05534438
Collaborator
(none)
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Study Details

Study Description

Brief Summary

The purpose of this study is to see if using Stereotactic Body Radiation Therapy/SBRT to treat a single metastatic site where cancer has worsened may be an effective treatment for people with oligometastatic breast cancer. Participants will stay on their usual drug therapy while they receive SBRT. This combination of SBRT to a single metastatic site and usual drug therapy may prevent participants' cancer from worsening in other metastatic sites or spreading.

Condition or Disease Intervention/Treatment Phase
  • Radiation: Stereotactic body radiotherapy
Phase 2

Study Design

Study Type:
Interventional
Anticipated Enrollment :
40 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Stereotactic Body Radiation Therapy (SBRT) to Extend the Benefit of Systemic Therapy in Patients With Solitary Disease Progression
Actual Study Start Date :
Sep 6, 2022
Anticipated Primary Completion Date :
Sep 6, 2025
Anticipated Study Completion Date :
Sep 6, 2025

Arms and Interventions

Arm Intervention/Treatment
Experimental: Participants with oligometastatic breast cancer

Participants with oligometastatic breast cancer with isolated progression after sustained (>=6 month) response to systemic therapy. Participants will receive image guided, SBRT to the progressive lesion identified on imaging. Participants will be maintained on their existing line of systemic therapy. Systemic therapy will be held during days of radiation and resume following completion of radiation.

Radiation: Stereotactic body radiotherapy
SBRT will be initiated as soon as possible, at not beyond 8 weeks of baseline measurements. Recommended dosing is per department standards for oligometastatic disease (ie, 10 Gy x 3 or 7-8 Gy x 5 fractions daily, excluding weekends and departmental holidays)
Other Names:
  • SBRT
  • Outcome Measures

    Primary Outcome Measures

    1. Progression free survival [3 months from start of SBRT delivery]

      The primary objective is to assess progression free survival, defined as systemic progression or death, within 3 months from start of Stereotactic Body Radiation Therapy/SBRT delivery.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Age 18 or older

    • Willing and able to provide informed consent

    • Metastatic breast cancer, biopsy proven

    • ER+/HER2-, defined as >5% ER+ staining

    • HER2+ (regardless of ER status), including HER2-low and high expressors

    • History of at least 6 months, sustained response to systemic therapy (clinically or radiographically defined as complete or stable response without progression)

    • Isolated site of disease progression on FDG PET scan

    • Consented to 12-245

    • ECOG performance status 0-1

    Exclusion Criteria:
    • Pregnancy

    • Serious medical comorbidity precluding radiation, including connective tissue disorders

    • Intracranial disease (including previous intracranial involvement)

    • Previous radiotherapy to the intended treatment site that precludes developing a treatment plan that respects normal tissue tolerances.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Memoral Sloan Kettering Basking Ridge (Limited Protocol Activities) Basking Ridge New Jersey United States 10065
    2 Memorial Sloan Kettering Monmouth (Limited Protocol Activities) Middletown New Jersey United States 07748
    3 Memorial Sloan Kettering Bergen (Limited Protocol Activities) Montvale New Jersey United States 07645
    4 Memorial Sloan Kettering Commack (Limited Protocol Activities) Commack New York United States 11725
    5 Memorial Sloan Kettering Westchester (Limited Protocol Activities) Harrison New York United States 10604
    6 Memorial Sloan Kettering Cancer Center (All Protocol Activities) New York New York United States 10065
    7 Memorial Sloan Kettering Nassau (Limited Protocol Activities) Uniondale New York United States 11553

    Sponsors and Collaborators

    • Memorial Sloan Kettering Cancer Center

    Investigators

    • Principal Investigator: Amy Xu, MD, PhD, Memorial Sloan Kettering Cancer Center

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Memorial Sloan Kettering Cancer Center
    ClinicalTrials.gov Identifier:
    NCT05534438
    Other Study ID Numbers:
    • 22-259
    First Posted:
    Sep 9, 2022
    Last Update Posted:
    Sep 9, 2022
    Last Verified:
    Sep 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    Yes
    Keywords provided by Memorial Sloan Kettering Cancer Center
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Sep 9, 2022