NCT05528133

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
86

participants targeted

Target at P50-P75 for phase_2

Timeline
24mo left

Started Jan 2023

Longer than P75 for phase_2

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress63%
Jan 2023May 2028

First Submitted

Initial submission to the registry

September 1, 2022

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 6, 2022

Completed
5 months until next milestone

Study Start

First participant enrolled

January 25, 2023

Completed
5.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2028

Last Updated

February 9, 2026

Status Verified

February 1, 2026

Enrollment Period

5.3 years

First QC Date

September 1, 2022

Last Update Submit

February 5, 2026

Conditions

Triple Negative Breast Cancer

Keywords

Breast CancerGenomically Guided Radiation

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • Overall Survival (OS)

    Up to 5 Years

  • Progression Free Survival (PFS)

    Up to 5 years

  • Distant Control

    Up to 5 Years

  • Quality of Life following Genomically Guided Dose Personalization

    Up to 5 Years

Study Arms (2)

Radiosensitivity Index optimized

EXPERIMENTAL

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

Radiosensitivity Index not optimized

ACTIVE COMPARATOR

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

Interventions

Genomically Guided Radiation TherapyRADIATION

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.

Radiosensitivity Index optimized

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Morton Plant Hospital - Baycare Health System

Clearwater, Florida, 33756, United States

RECRUITING

Moffitt Cancer Center

Tampa, Florida, 33612, United States

RECRUITING

Related Links

MeSH Terms

Conditions

Triple Negative Breast NeoplasmsBreast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Kamran Ahmed, MD

    Moffitt Cancer Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Robin Dowell

CONTACT

813-745-0393Robin.Dowell@moffitt.org

Kamran Ahmed, MD

CONTACT

813-745-3320Kamran.Ahmed@moffitt.org

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 1, 2022

First Posted

September 6, 2022

Study Start

January 25, 2023

Primary Completion (Estimated)

May 1, 2028

Study Completion (Estimated)

May 1, 2028

Last Updated

February 9, 2026

Record last verified: 2026-02

Locations

US(2)