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Trial Title:
Genomically Guided Radiation Therapy in the Management of Triple Negative Breast Cancer
NCT ID:
NCT05528133
Condition:
Triple Negative Breast Cancer
Conditions: Official terms:
Breast Neoplasms
Triple Negative Breast Neoplasms
Conditions: Keywords:
Breast Cancer
Genomically Guided Radiation
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Radiation
Intervention name:
Genomically Guided Radiation Therapy
Description:
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.
Arm group label:
Radiosensitivity Index optimized
Intervention type:
Radiation
Intervention name:
Genomically Guided Radiation Therapy
Description:
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.
Arm group label:
Radiosensitivity Index not optimized
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.
Criteria for 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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Morton Plant Hospital - Baycare Health System
Address:
City:
Clearwater
Zip:
33756
Country:
United States
Status:
Recruiting
Contact:
Last name:
Ken Tardif
Phone:
727-462-3921
Email:
Ken.Tardif@baycare.org
Investigator:
Last name:
Ronica H. Nanda, MD
Email:
Principal Investigator
Facility:
Name:
Moffitt Cancer Center
Address:
City:
Tampa
Zip:
33612
Country:
United States
Status:
Recruiting
Contact:
Last name:
Michelle DeJesus
Phone:
813-745-6911
Email:
Michelle.DeJesus@moffitt.org
Investigator:
Last name:
Kamran Ahmed, MD
Email:
Principal Investigator
Investigator:
Last name:
Ronica H Nanda, MD
Email:
Principal Investigator
Start date:
January 25, 2023
Completion date:
January 2027
Lead sponsor:
Agency:
H. Lee Moffitt Cancer Center and Research Institute
Agency class:
Other
Source:
H. Lee Moffitt Cancer Center and Research Institute
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05528133
https://moffitt.org/clinical-trials-research/clinical-trials/?gclid=EAIaIQobChMImIymzIa-9gIVAZ2GCh3uzAWJEAAYASAAEgI0ovD_BwE
