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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05528133
Recruitment Status : Recruiting
First Posted : September 6, 2022
Last Update Posted : May 12, 2023
Sponsor:
Information provided by (Responsible Party):
H. Lee Moffitt Cancer Center and Research Institute

Study Description
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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.

Condition or disease Intervention/treatment Phase
Triple Negative Breast Cancer Radiation: Genomically Guided Radiation Therapy Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 86 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Study of Genomically Guided Radiation Dose Personalization in the Management of Triple Negative Breast Cancer
Actual Study Start Date : November 4, 2022
Estimated Primary Completion Date : November 1, 2025
Estimated Study Completion Date : November 1, 2026

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arms and Interventions
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Arm Intervention/treatment
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.
 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.
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.
 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 a boost of 10 Gy in 5 fractions to the cavity.


Outcome Measures
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Primary Outcome Measures :
  1. Local Control [ Time Frame: At 3 Years ]
    Local control will be defined as lack of progression in the ipsilateral breast as documented by response assessment imaging


Secondary Outcome Measures :
  1. Overall Survival (OS) [ Time Frame: Up to 5 Years ]
    OS will be measured from the date of study initiation to the date of death due to any cause.

  2. Progression Free Survival (PFS) [ Time Frame: Up to 5 years ]
    PFS is measured from the date of first treatment to the date of first observation of PD or death due to any cause.

  3. Distant Control [ Time Frame: Up to 5 Years ]
    Distant control will be defined by lack of progression outside the irradiated treatment field

  4. Quality of Life following Genomically Guided Dose Personalization [ Time Frame: Up to 5 Years ]
    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


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 (<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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05528133


Contacts
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Contact: Michelle DeJesus 813-745-6911 Michelle.DeJesus@moffitt.org
Contact: Kamran Ahmed, MD 813-745-3320 Kamran.Ahmed@moffitt.org

Locations
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United States, Florida
Morton Plant Hospital - Baycare Health System Recruiting
Clearwater, Florida, United States, 33756
Contact: Ken Tardif    727-462-3921    Ken.Tardif@baycare.org   
Principal Investigator: Roberto Diaz, MD, PhD         
Moffitt Cancer Center Recruiting
Tampa, Florida, United States, 33612
Contact: Michelle DeJesus    813-745-6911    Michelle.DeJesus@moffitt.org   
Principal Investigator: Kamran Ahmed, MD         
Principal Investigator: Roberto Diaz, MD, PhD         
Sponsors and Collaborators
H. Lee Moffitt Cancer Center and Research Institute
Investigators
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Principal Investigator: Kamran Ahmed, MD Moffitt Cancer Center
More Information
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Additional Information:

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Responsible Party: H. Lee Moffitt Cancer Center and Research Institute
ClinicalTrials.gov Identifier: NCT05528133    
Other Study ID Numbers: MCC-21757
First Posted: September 6, 2022    Key Record Dates
Last Update Posted: May 12, 2023
Last Verified: February 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by H. Lee Moffitt Cancer Center and Research Institute:
Breast Cancer
Genomically Guided Radiation
Additional relevant MeSH terms:
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Breast Neoplasms
Triple Negative Breast Neoplasms
Neoplasms by Site
 Neoplasms
Breast Diseases
Skin Diseases