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

Description

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.

Conditions

Triple Negative Breast Cancer

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Study Overview

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Study Details

Study overview

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.

Phase II Study of Genomically Guided Radiation Dose Personalization in the Management of Triple Negative Breast Cancer

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

Condition
Triple Negative Breast Cancer
Intervention / Treatment

-

Contacts and Locations

Clearwater

Morton Plant Hospital - Baycare Health System, Clearwater, Florida, United States, 33756

Tampa

Moffitt Cancer Center, Tampa, Florida, United States, 33612

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

H. Lee Moffitt Cancer Center and Research Institute,

Kamran Ahmed, MD, PRINCIPAL_INVESTIGATOR, Moffitt Cancer Center

Study Record Dates

2027-01