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Clinical Trial 21757

Cancer Type: Breast
Study Type: Treatment
NCT#: NCT05528133

Phase: Phase II
Principal Investigator: Ahmed, Kamran

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or 1-800-679-0775 Learn More
Overview

Study Title

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

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.

Objective

Primary Objective: To determine the three year local control following genomically guided dose escalation in the management of triple negative (TN) breast cancer following BCT. Secondary Objectives: To determine the overall survival (OS) following genomically guided dose escalation in the management of TN breast cancer following BCT. To determine the progression free survival (PFS) following genomically guided dose escalation in the management of TN breast cancer following BCT. To determine the distant control (DC) rate following genomically guided dose escalation in the management of TN breast cancer following BCT. To determine safety following genomically guided dose escalation in the management of TN breast cancer following BCT. To determine quality of life (QOL) following genomically guided dose escalation in the management of TN breast cancer following BCT.

Treatments

Therapies

Radiotherapy

Medications

Radiotherapy ()

Inclusion 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
  • 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
  • Other criteria may apply

  • Exclusion Criteria

    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
  • Other exclusions may apply

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