Genomically Guided Radiation Therapy in the Management of Triple Negative Breast Cancer

Launched by H. LEE MOFFITT CANCER CENTER AND RESEARCH INSTITUTE · Sep 1, 2022

Keywords

ClinConnect Summary

This clinical trial is studying a new approach called genomically guided radiation therapy for people with triple negative breast cancer, which is a type of cancer that does not have certain hormone receptors or HER2 protein. The goal is to see if this treatment can be safely used alongside breast conservation therapy, which involves removing the tumor while saving as much healthy breast tissue as possible. The trial is currently looking for participants aged 18 and older who have already had surgery to remove their tumor and have been confirmed to have triple negative breast cancer.

To be eligible for the trial, participants need to have adequate tissue samples for testing and should not have any signs of HER2 overexpression or hormone receptor expression. They should also be in good health, with a life expectancy of at least 16 weeks. Participants can expect to receive detailed information about the study and will need to provide consent before enrolling. This trial is an opportunity to explore a personalized approach to radiation therapy, which could lead to better treatment options for this challenging type of breast cancer.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Participants should have undergone breast conservation therapy with a lumpectomy and axillary evaluation to consist of a sentinel node biopsy or axillary dissection
• • Confirmation of Triple Negative (TN) breast cancer by tissue biopsy
• • Adequate tissue to calculate RSI
• • To fulfill the requirement of HER2- disease, a breast cancer must not demonstrate, at initial diagnosis or upon subsequent biopsy, overexpression of HER2 by either IHC or in-situ hybridization as defined by the ASCO / CAP Guidelines
• • To fulfill the requirement of hormone receptor (HR)- disease, a breast cancer must express (\<10%), by immunohistochemistry (IHC), the hormone receptors (estrogen receptor \[ER\] and progesterone receptor \[PR\]) as defined in the American Society of Clinical Oncology (ASCO) / College of American Pathologists (CAP) Guidelines
• • Life expectancy \>16 weeks
• • KPS ≥ 70
• • Age ≥ 18 years
• • Participants with surgery within 14 days should have recovered from all effects of the surgery and be cleared by their surgeon
• • There is no limit on prior systemic therapies
• • Women of childbearing potential and sexually active males must commit to the use of effective contraception while on study
• • Ability to sign an informed consent form, which can be signed by a family member or health care proxy. Informed consent must be given before study enrollment
• Exclusion Criteria:
• • Major surgery or significant traumatic injury that has not been recovered from 14 days before study initiation
• • Women who are pregnant or breastfeeding
• • Positive surgical margins
• • History of allergy or hypersensitivity to any of the study drugs or study drug components
• • Metastatic breast cancer