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NCT Number: NCT05528133

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

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.

Recruiting

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Key information

Conditions

Triple Negative Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases Triple Negative Breast Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

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

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Genomically Guided Radiation Therapy

Radiation

Participants will receive treatment 5 days per week, in once daily fractions. The total dose will be 50 Gy in 25 fractions or 42.56 Gy in 16 fractions with or without a boost of 10 Gy in 5 fractions to the cavity.

Primary outcomes

  1. Local Control

    Time frame: At 3 Years

    Local control will be defined as lack of progression in the ipsilateral breast as documented by response assessment imaging

Secondary outcomes

  1. Overall Survival (OS)

    Time frame: Up to 5 Years

    OS will be measured from the date of study initiation to the date of death due to any cause.

  2. Progression Free Survival (PFS)

    Time frame: Up to 5 years

    PFS is measured from the date of first treatment to the date of first observation of PD or death due to any cause.

  3. Distant Control

    Time frame: Up to 5 Years

    Distant control will be defined by lack of progression outside the irradiated treatment field

  4. Quality of Life following Genomically Guided Dose Personalization

    Time frame: Up to 5 Years

    Quality of life (QOL) will be assessed through the completion of the Functional Assessment of Cancer Therapy for Breast Cancer questionnaire (FACT-B). This quality of life questionnaire contains questions from the FACT-General (G) questionnaire in the domains of physical, social/family, emotional, and functional well-being as well as additional questions pertaining to patients with breast cancer. The questionnaire will be completed at screening, during protocol therapy and at follow-up visits

Study contacts

Contact information is provided by the study sponsor or research team.

Kamran Ahmed, MD

CONTACT

[email protected]

813-745-3320

Robin Dowell

CONTACT

[email protected]

813-745-0393

Sponsors and collaborators

Lead sponsor

H. Lee Moffitt Cancer Center and Research Institute

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2028
Study completion
2028
First posted
Sep 6, 2022
Registry last updated
Feb 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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