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

Purpose

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.

Condition

  • Triple Negative Breast Cancer

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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

Phase
Phase 2
Study Type
Interventional
Allocation
Non-Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
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.
  • Radiation: 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.
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.
  • Radiation: 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.

Recruiting Locations

Morton Plant Hospital - Baycare Health System
Clearwater 4151316, Florida 4155751 33756
Contact:
Ken Tardif
727-462-3921
Ken.Tardif@baycare.org

Moffitt Cancer Center
Tampa 4174757, Florida 4155751 33612

More Details

Status
Recruiting
Sponsor
H. Lee Moffitt Cancer Center and Research Institute

Study Contact

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