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

Phase 2

Recruiting

• Conditions: Metastatic Breast Cancer; HER2+ Breast Cancer; Metastatic Breast Carcinoma; Breast Cancer; ER+ Breast Cancer; Oligometastatic Breast Carcinoma
• Interventions: Radiation: Stereotactic body radiotherapy

• Registration Number: NCT05534438
• Lead Sponsor: Memorial Sloan Kettering Cancer Center

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-09-06
• Study First Submitted: 2022-09-06
• Study First Submitted QC: 2022-09-06
• Study First Posted: 2022-09-09
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-15
• Last Update Posted: 2025-05-20
• Primary Completion: 2025-09-06
• Study Completion: 2025-09-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Participants with oligometastatic breast cancer	Stereotactic body radiotherapy	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.

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (8)

Memorial Sloan Kettering Commack (Limited Protocol Activities); 🇺🇸 Commack, New York, United States

Memorial Sloan Kettering Cancer Center (All Protocol Activities); 🇺🇸 New York, New York, United States

Memorial Sloan Kettering Westchester (Limited Protocol Activities); 🇺🇸 Harrison, New York, United States

Lehigh Valley Health Network (Data Collection Only); 🇺🇸 Allentown, Pennsylvania, United States

Memorial Sloan Kettering Nassau (Limited Protocol Activities); 🇺🇸 Uniondale, New York, United States

Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities); 🇺🇸 Basking Ridge, New Jersey, United States

Memorial Sloan Kettering Bergen (Limited Protocol Activities); 🇺🇸 Montvale, New Jersey, United States

Memorial Sloan Kettering Monmouth (Limited Protocol Activities); 🇺🇸 Middletown, New Jersey, United States