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Clinical Trial NCT05528133 for Triple Negative Breast Cancer is recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here. | ||
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Genomically Guided Radiation Therapy in the Management of Triple Negative Breast Cancer Phase 2 86
Clinical Trial NCT05528133 is designed to study Treatment for Triple Negative Breast Cancer. It is a Phase 2 interventional study that is recruiting, having started on January 25, 2023, with plans to enroll 86 participants. Led by H. Lee Moffitt Cancer Center and Research Institute, it is expected to complete by May 1, 2028. The latest data from ClinicalTrials.gov was last updated on February 9, 2026.
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.
Official Title
Phase II Study of Genomically Guided Radiation Dose Personalization in the Management of Triple Negative Breast Cancer
Conditions
Triple Negative Breast CancerOther Study IDs
- MCC-21757
NCT ID Number
Start Date (Actual)
2023-01-25
Last Update Posted
2026-02-09
Completion Date (Estimated)
2028-05
Enrollment (Estimated)
86
Study Type
Interventional
PHASE
Phase 2
Status
Recruiting
Keywords
Breast Cancer
Genomically Guided Radiation
Genomically Guided Radiation
Primary Purpose
Treatment
Design Allocation
Non-Randomized
Interventional Model
Parallel
Masking
None (Open Label)
Arms / Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
ExperimentalRadiosensitivity 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. | 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 ComparatorRadiosensitivity 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. | 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. |
Primary Outcome Measures
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
Local Control | Local control will be defined as lack of progression in the ipsilateral breast as documented by response assessment imaging | At 3 Years |
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
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 |
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 |
Distant Control | Distant control will be defined by lack of progression outside the irradiated treatment field | Up to 5 Years |
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 |
Participation Assistant
Eligibility Criteria
Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All
- 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
- 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
H. Lee Moffitt Cancer Center and Research InstituteStudy Central Contact
Contact: Robin Dowell, 813-745-0393, [email protected]
Contact: Kamran Ahmed, MD, 813-745-3320, [email protected]
2 Study Locations in 1 Countries
Florida
Morton Plant Hospital - Baycare Health System, Clearwater, Florida, 33756, United States
Ken Tardif, Contact, 727-462-3921, [email protected]
Ronica H. Nanda, MD, Principal Investigator
Recruiting
Moffitt Cancer Center, Tampa, Florida, 33612, United States
Kamran Ahmed, MD, Principal Investigator
Ronica H Nanda, MD, Principal Investigator
Recruiting