Clinical trial NCT05528133: Genomically Guided Radiation Therapy in the Management of Triple Negative Breast Cancer
Official title: Phase II Study of Genomically Guided Radiation Dose Personalization in the Management of Triple Negative Breast Cancer
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Triple Negative Breast Cancer
Keywords: Breast Cancer
Genomically Guided Radiation
Lead sponsor: H. Lee Moffitt Cancer Center and Research Institute
Sponsor class: OTHER
First posted: 2022-09-06
Enrollment: 86
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Local Control
timeFrame: At 3 Years
Secondary outcomes:
measure: Overall Survival (OS)
timeFrame: Up to 5 Years
measure: Progression Free Survival (PFS)
timeFrame: Up to 5 years
measure: Distant Control
timeFrame: Up to 5 Years
measure: Quality of Life following Genomically Guided Dose Personalization
timeFrame: Up to 5 Years
Other outcomes:
Locations:
city: Clearwater
country: United States
facility: Morton Plant Hospital - Baycare Health System
state: Florida
city: Tampa
country: United States
facility: Moffitt Cancer Center
state: Florida
Study officials:
affiliation: Moffitt Cancer Center
name: Kamran Ahmed, MD
role: PRINCIPAL_INVESTIGATOR
References: