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

Launched by MEMORIAL SLOAN KETTERING CANCER CENTER · Sep 6, 2022

Keywords

ClinConnect Summary

This clinical trial is studying a new approach to treating breast cancer by combining a targeted radiation therapy called Stereotactic Body Radiation Therapy (SBRT) with standard drug treatments. The goal is to see if using SBRT on a specific area where the cancer has worsened can help prevent the cancer from getting worse in other parts of the body or from spreading further. Patients will continue their usual medication while receiving this focused radiation treatment.

To be eligible for this trial, participants must be 18 years or older and have a confirmed diagnosis of metastatic breast cancer, meaning the cancer has spread from the original site to other parts of the body. They should have been responding well to their current treatment for at least six months and have a specific area of cancer progression that can be identified on a special imaging test. Participants can expect to receive careful monitoring throughout the study to assess how well this combination treatment works. It's important to note that certain individuals, such as those who are pregnant or have specific medical conditions, may not be able to participate.

Gender

ALL

Eligibility criteria

• 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.