Study on Using Genomically Guided Radiation Therapy for Treating Triple Negative Breast Cancer

Sponsor: H. Lee Moffitt Cancer Center and Research Institute

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT05528133

This clinical trial is exploring the use of genomically guided radiation therapy to treat patients with triple negative breast cancer who are undergoing breast conservation therapy.

Patient Parameters

Program Overview

The aim of this study is to see if using genomically guided radiation therapy is feasible for patients with triple negative breast cancer who are receiving breast conservation therapy, which includes procedures like lumpectomy.

Eligibility Criteria

Inclusion Criteria

  • Must have had breast conservation therapy, including a lumpectomy and evaluation of lymph nodes in the armpit area.
  • Must have a confirmed diagnosis of Triple Negative breast cancer through a tissue biopsy.
  • Must have enough tissue available to calculate a specific genomic score (RSI).
  • The cancer must not show overexpression of HER2, as determined by specific medical tests.
  • The cancer must show less than 10% expression of hormone receptors (estrogen and progesterone) based on medical guidelines.
  • Must have a life expectancy of more than 16 weeks.
  • Must have a Karnofsky Performance Status (KPS) score of 70 or higher, indicating the ability to care for oneself.
  • Must be 18 years or older.
  • If surgery was performed within the last 14 days, the participant must have recovered and been cleared by their surgeon.
  • There is no restriction on previous treatments received.
  • Women who can become pregnant and sexually active men must agree to use effective birth control during the study.
  • Must be able to sign an informed consent form, or have a family member or healthcare proxy sign on their behalf before joining the study.

Exclusion Criteria

  • Have had major surgery or a significant injury that has not healed within 14 days before starting the study.
  • Are pregnant or breastfeeding.
  • Have positive surgical margins, meaning cancer cells are found at the edge of the tissue removed during surgery.
  • Have a history of allergy or sensitivity to any of the study drugs or their components.
  • Have metastatic breast cancer, meaning the cancer has spread to other parts of the body.

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