← Back to Search

Radiation Therapy

Genomic-Guided Radiation Therapy for Breast Cancer

Phase 2
Recruiting
Led By Kamran Ahmed, MD
Research Sponsored by H. Lee Moffitt Cancer Center and Research Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
No Placebo-Only Group

Study Summary

This trial will test whether a new way of giving radiation therapy, based on the DNA of a person's tumor, can help people with a certain type of breast cancer.

Who is the study for?
This trial is for adults over 18 with triple negative breast cancer who've had a lumpectomy and axillary evaluation. They must not be pregnant or breastfeeding, have recovered from recent surgeries, and agree to use effective contraception. Participants need a life expectancy over 16 weeks and a performance status score of at least 70.Check my eligibility
What is being tested?
The study tests genomically guided radiation therapy in patients with triple negative breast cancer following breast conservation surgery. It aims to assess the feasibility of tailoring radiation treatment based on genetic markers.See study design
What are the potential side effects?
While specific side effects are not listed here, radiation therapy can generally cause skin irritation at the treatment site, fatigue, mild swelling, and changes in breast texture.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I had a lumpectomy and my underarm lymph nodes were checked.
Select...
My breast cancer is confirmed as Triple Negative by a biopsy.
Select...
My biopsy has enough tissue for the required test.
Select...
My breast cancer does not show high levels of HER2.
Select...
My breast cancer is not driven by hormones.
Select...
I am mostly able to care for myself.
Select...
I am 18 years old or older.
Select...
I have recovered from recent surgery and my surgeon has cleared me.
Select...
I have had multiple treatments for my condition.
Select...
I am committed to using effective birth control during the study.
Select...
I can sign or have someone authorized to sign the consent form for me.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Local Control
Secondary outcome measures
Distant Control
Overall Survival (OS)
Progression Free Survival (PFS)
+1 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Radiosensitivity Index optimizedExperimental Treatment1 Intervention
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.
Group II: Radiosensitivity Index not optimizedActive Control1 Intervention
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.

Find a Location

Who is running the clinical trial?

H. Lee Moffitt Cancer Center and Research InstituteLead Sponsor
535 Previous Clinical Trials
134,475 Total Patients Enrolled
41 Trials studying Breast Cancer
5,759 Patients Enrolled for Breast Cancer
Kamran Ahmed, MDPrincipal InvestigatorMoffitt Cancer Center
3 Previous Clinical Trials
84 Total Patients Enrolled
1 Trials studying Breast Cancer
31 Patients Enrolled for Breast Cancer

Media Library

Genomically Guided Radiation Therapy (Radiation Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT05528133 — Phase 2
Breast Cancer Research Study Groups: Radiosensitivity Index optimized, Radiosensitivity Index not optimized
Breast Cancer Clinical Trial 2023: Genomically Guided Radiation Therapy Highlights & Side Effects. Trial Name: NCT05528133 — Phase 2
Genomically Guided Radiation Therapy (Radiation Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05528133 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has the FDA authorised Genomically Guided Radiation Therapy for clinical use?

"Our team at Power provided Genomically Guided Radiation Therapy a score of 2 because this is presently in Phase 2, which means it has some evidence backing its safety but does not yet have any data supporting efficacy."

Answered by AI

Are there any availabilities for individuals to take part in this trial?

"Clinicaltrials.gov confirms that this medical trial is actively seeking patients, with the initial posting occuring on November 4th 2022 and its most recent update taking place 10 days later."

Answered by AI

How many participants have enrolled in this research endeavor?

"Affirmative. According to information published on clinicaltrials.gov, this medical trial began recruitment on November 4th 2022 and is still ongoing. A total of 86 study subjects need to be enrolled from a single site."

Answered by AI
~49 spots leftby Nov 2025