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

Memorial Sloan Kettering Cancer Center (MSK)

Status and phase: Enrolling; Phase 2

Conditions: Breast Cancer; Oligometastatic Breast Carcinoma; Metastatic Breast Carcinoma; HER2+ Breast Cancer; Metastatic Breast Cancer; ER+ Breast Cancer

Treatments: Radiation: Stereotactic body radiotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT05534438

22-259

Details and patient eligibility

About

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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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40 participants in 1 patient group

Participants with oligometastatic breast cancer

Experimental group

Description:

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.

Treatment:

Radiation: Stereotactic body radiotherapy