Study on Adding Targeted Radiation Therapy to Standard Drug Treatment for Breast Cancer

Sponsor: Memorial Sloan Kettering Cancer Center

Sponsor score: 60

ClinicalTrials ID:NCT05534438

This clinical trial is exploring whether adding a precise form of radiation therapy, called Stereotactic Body Radiation Therapy (SBRT), to the usual drug treatment can help control breast cancer that has spread to a single site. Participants will continue their regular medication while receiving SBRT to see if this combination can prevent the cancer from worsening or spreading further.

Patient Parameters

Program Overview

The aim of this study is to determine if using Stereotactic Body Radiation Therapy (SBRT) on a single area where breast cancer has spread can be an effective treatment for patients with oligometastatic breast cancer. Participants will continue their usual drug therapy while receiving SBRT. This approach may help stop the cancer from getting worse in other areas or spreading to new sites.

Eligibility Criteria

Inclusion Criteria

  • Must be 18 years or older.
  • Able and willing to provide informed consent.
  • Have metastatic breast cancer confirmed by a biopsy.
    • ER+/HER2-, meaning more than 5% of cancer cells show ER+ staining.
    • HER2+ regardless of ER status, including both low and high HER2 expressors.
  • Have had at least 6 months of stable response to systemic therapy, meaning the cancer has not progressed.
  • Have a single site of cancer progression shown on an FDG PET scan.
  • Have agreed to participate in study 12-245.
  • Have an ECOG performance status of 0 or 1, indicating full activity or some restriction in strenuous activities.

Exclusion Criteria

  • Currently pregnant.
  • Have serious medical conditions that prevent safe radiation treatment, such as connective tissue disorders.
  • Have cancer that has spread to the brain or a history of brain involvement.
  • Have had previous radiation to the area planned for treatment that would make it unsafe to proceed.

Locations

FACILITYZIPCITYSTATE
Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)10065Basking RidgeNew Jersey
Memorial Sloan Kettering Monmouth (Limited Protocol Activities)07748MiddletownNew Jersey
Memorial Sloan Kettering Bergen (Limited Protocol Activities)07645MontvaleNew Jersey
Memorial Sloan Kettering Commack (Limited Protocol Activities)11725CommackNew York
Memorial Sloan Kettering Westchester (Limited Protocol Activities)10604HarrisonNew York
Memorial Sloan Kettering Cancer Center (All Protocol Activities)10065New YorkNew York
Memorial Sloan Kettering Nassau (Limited Protocol Activities)11553UniondaleNew York
Lehigh Valley Health Network (Data Collection Only)18103AllentownPennsylvania

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