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

Triple Negative Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05528133
• Other study ID #: MCC-21757
• Status: Recruiting
• Phase: Phase 2
• Start date: November 4, 2022
• Est. completion date: November 1, 2026

Study information

• Verified date: January 2024
• Source: H. Lee Moffitt Cancer Center and Research Institute
• Contact: Michelle DeJesus
• Phone: 813-745-6911
• Email: Michelle.DeJesus[@]moffitt.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 86
• Est. completion date: November 1, 2026
• Est. primary completion date: November 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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 (<5%), 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

Related Conditions & MeSH terms

• Breast Neoplasms
• Triple Negative Breast Cancer
• Triple Negative Breast Neoplasms

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Morton Plant Hospital - Baycare Health System	Clearwater	Florida
United States	Moffitt Cancer Center	Tampa	Florida

Sponsors (1)

Lead Sponsor	Collaborator
H. Lee Moffitt Cancer Center and Research Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Local Control	Local control will be defined as lack of progression in the ipsilateral breast as documented by response assessment imaging	At 3 Years
Secondary	Overall Survival (OS)	OS will be measured from the date of study initiation to the date of death due to any cause.	Up to 5 Years
Secondary	Progression Free Survival (PFS)	PFS is measured from the date of first treatment to the date of first observation of PD or death due to any cause.	Up to 5 years
Secondary	Distant Control	Distant control will be defined by lack of progression outside the irradiated treatment field	Up to 5 Years
Secondary	Quality of Life following Genomically Guided Dose Personalization	Quality of life (QOL) will be assessed through the completion of the Functional Assessment of Cancer Therapy for Breast Cancer questionnaire (FACT-B). This quality of life questionnaire contains questions from the FACT-General (G) questionnaire in the domains of physical, social/family, emotional, and functional well-being as well as additional questions pertaining to patients with breast cancer. The questionnaire will be completed at screening, during protocol therapy and at follow-up visits	Up to 5 Years

External Links

•   Moffitt Clinical Trial Search