Genomically Guided Radiation Therapy for Breast Cancer (Triple Negative Breast Cancer (TNBC))

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Moffitt Cancer Center, Tampa, FL
Breast Cancer (Triple Negative Breast Cancer (TNBC))+2 More
Genomically Guided Radiation Therapy - Radiation
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study 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.

Eligible Conditions

  • Breast Cancer (Triple Negative Breast Cancer (TNBC))

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Breast Cancer (Triple Negative Breast Cancer (TNBC))

Study Objectives

1 Primary · 4 Secondary · Reporting Duration: Up to 5 Years

At 3 Years
Local Control
Up to 5 Years
Distant Control
Overall Survival (OS)
Quality of Life following Genomically Guided Dose Personalization
Up to 5 years
Progression Free Survival (PFS)

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Other trials for Breast Cancer (Triple Negative Breast Cancer (TNBC))

Trial Design

2 Treatment Groups

Radiosensitivity Index not optimized
1 of 2
Radiosensitivity Index optimized
1 of 2
Active Control
Experimental Treatment

86 Total Participants · 2 Treatment Groups

Primary Treatment: Genomically Guided Radiation Therapy · No Placebo Group · Phase 2

Radiosensitivity Index optimized
Radiation
Experimental Group · 1 Intervention: Genomically Guided Radiation Therapy · Intervention Types: Radiation
Radiosensitivity Index not optimized
Radiation
ActiveComparator Group · 1 Intervention: Genomically Guided Radiation Therapy · Intervention Types: Radiation

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 5 years
Closest Location: Moffitt Cancer Center · Tampa, FL
Photo of moffitt cancer center 1Photo of moffitt cancer center 2Photo of moffitt cancer center 3
2009First Recorded Clinical Trial
15 TrialsResearching Breast Cancer (Triple Negative Breast Cancer (TNBC))
222 CompletedClinical Trials

Who is running the clinical trial?

H. Lee Moffitt Cancer Center and Research InstituteLead Sponsor
486 Previous Clinical Trials
123,316 Total Patients Enrolled
3 Trials studying Breast Cancer (Triple Negative Breast Cancer (TNBC))
148 Patients Enrolled for Breast Cancer (Triple Negative Breast Cancer (TNBC))
Kamran Ahmed, MDPrincipal InvestigatorMoffitt Cancer Center
2 Previous Clinical Trials
53 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 9 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You have TN breast cancer.
You have a life expectancy of at least 16 weeks.
You are recovering from surgery and are cleared by your surgeon.
You are of childbearing potential and are sexually active
You must be able to give informed consent before study enrollment.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.