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

Part of paid clinical trials in Clearwater, Florida.

Sponsor
H. Lee Moffitt Cancer Center and Research Institute
Study ID
NCT05528133
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Jan 25, 2023
Status verified
Feb 2026
Primary completion
May 31, 2028
Completion
May 31, 2028

Study Design

Enrollment
86 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

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.

Primary Outcome Measure

Local Control [ Time Frame: At 3 Years ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Morton Plant Hospital - Baycare Health SystemClearwaterFlorida33756
Ken Tardif
[email protected]
727-462-3921
Ronica H. Nanda, MD (PRINCIPAL_INVESTIGATOR)
Moffitt Cancer CenterTampaFlorida33612
Kamran Ahmed, MD (PRINCIPAL_INVESTIGATOR)
Ronica H Nanda, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Clearwater, FL

By condition
Breast cancer
By specialty
OncologyBreast oncologyWomen's health
By research site
Morton Plant Hospital - Baycare Health System· Clearwater, FLMoffitt Cancer Center· Tampa, FL

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