Back to Trials
NCT05528133PHASE2Recruiting

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

H. Lee Moffitt Cancer Center and Research Institute

Start Date

1/25/2023

Completion Date

5/1/2028

Summary

The purpose of the study is to determine the feasibility of genomically guided radiation therapy (RT) in people with triple negative (HER2 negative, hormone receptor negative) breast cancer undergoing breast conservation therapy.

Eligibility Criteria

Age Range: 18 years to No maximum

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

Interventions

RADIATION

Genomically Guided Radiation Therapy

RADIATION

Genomically Guided Radiation Therapy

Interested in This Trial?

Contact the trial locations directly using the information below to learn more about enrollment.

Expressing interest lets you review the study and consent before we connect you with the research site.

Conditions

Triple Negative Breast Cancer

Locations

Morton Plant Hospital - Baycare Health System

Clearwater, Florida 33756

United States

Moffitt Cancer Center

Tampa, Florida 33612

United States