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

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Radiation
Study Type: Interventional
Study Phase: Phase 2
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
United States
Florida
Morton Plant Hospital - Baycare Health System
RECRUITING
Clearwater
Moffitt Cancer Center
RECRUITING
Tampa
Contact Information
Primary
Michelle DeJesus
Michelle.DeJesus@moffitt.org
813-745-6911
Backup
Kamran Ahmed, MD
Kamran.Ahmed@moffitt.org
813-745-3320
Time Frame
Start Date: 2023-01-25
Estimated Completion Date: 2027-01
Participants
Target number of participants: 86
Treatments
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.
Sponsors
Leads: H. Lee Moffitt Cancer Center and Research Institute

This content was sourced from clinicaltrials.gov