Recruiting
Phase 2

Genomically Guided RT

Sponsor:

H. Lee Moffitt Cancer Center and Research Institute

Code:

NCT05528133

Conditions

Triple Negative Breast Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Genomically Guided Radiation Therapy

Genomically Guided Radiation Therapy

Study Details

Brief 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.

Conditions

Triple Negative Breast Cancer

Study ID

NCT05528133

Start date

Jan 25, 2023

Status verified date

Sep, 2026

Completion date

Sep, 2029

Anticipated

Primary completion date

Sep, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

86 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Radiosensitivity Index optimized

Participants will be assigned to optimized arm based on their RSI score. Participants will receive whole breast radiation therapy with or without regional lymph node irradiation as appropriate with or without a boost to the lumpectomy cavity.

active comparator: Radiosensitivity Index not optimized

Participants will receive standard of care whole breast radiation therapy with or without regional lymph node irradiation as appropriate with a boost to the lumpectomy cavity.

Interventions

Genomically Guided Radiation Therapy

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.

Genomically Guided Radiation Therapy

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 a boost of 10 Gy in 5 fractions to the cavity.

Primary outcome measure

  • Local Control [ Time Frame: At 3 Years ]

Central Contacts and Locations

Central contacts

Robin Dowell

813-745-0393Robin.Dowell@moffitt.org

Kamran Ahmed, MD

813-745-3320Kamran.Ahmed@moffitt.org

Locations

Morton Plant Hospital - Baycare Health System

Recruiting

Clearwater, Florida, United States, 33756

Contacts

Ken Tardif

727-462-3921Ken.Tardif@baycare.org

Principal Investigator:

Ronica H. Nanda, MD

Moffitt Cancer Center

Recruiting

Tampa, Florida, United States, 33612

Principal Investigator:

Kamran Ahmed, MD

More Information

Sponsor

H. Lee Moffitt Cancer Center and Research Institute

Last update posted

Sep 25, 2026

Last verified

Sep, 2026

Keywords

  • Breast Cancer
  • Genomically Guided Radiation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-07. This information was provided to ClinicalTrials.gov by H. Lee Moffitt Cancer Center and Research Institute on 2026-09-25. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.