RecruitingPhase 2NCT05528133

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

Phase II Study of Genomically Guided Radiation Dose Personalization in the Management of Triple Negative Breast Cancer

Sponsor

H. Lee Moffitt Cancer Center and Research Institute

Enrollment

86 participants

Start Date

Jan 25, 2023

Study Type

INTERVENTIONAL

Conditions

Triple-Negative Breast Cancer

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is using a genomic test called RSI (Radiation Sensitivity Index) to guide radiation therapy decisions in people with triple-negative breast cancer (TNBC) who had a lumpectomy. The goal is to tailor radiation to each patient's specific tumor biology. **You may be eligible if...** - You are 18 or older with confirmed triple-negative breast cancer (ER-, PR-, HER2-) - You have undergone a lumpectomy (breast-conserving surgery) with sentinel node or axillary lymph node evaluation - Your tumor tissue has enough material to calculate the RSI score - You are in generally good health (Karnofsky score ≥70) - You agree to use effective contraception if of childbearing potential **You may NOT be eligible if...** - You have not recovered from recent major surgery (within the last 14 days) - Your cancer does not meet the criteria for triple-negative classification Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

RADIATIONGenomically 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.

RADIATIONGenomically 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.

Locations(2)

Morton Plant Hospital - Baycare Health System

Clearwater, Florida, United States

Moffitt Cancer Center

Tampa, Florida, United States

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT05528133

Related Trials

Phase I Study of [177Lu]Lu-DFC413 in Patients With Solid Tumors

NCT072616318 locations

Study to Assess Adverse Events and Pharmacokinetics in Adult Participants With Non-Small Cell Lung Cancer, Head and Neck Squamous Cell Carcinoma and Other Solid Tumors, Receiving Intravenous Infusion of Azirkitug Alone or in Combination(s) With Budigalimab, Bevacizumab, or Telisotuzumab Adizutecan

NCT0500540346 locations

A Study to Investigate Safety of AZD6750 in Adult Participants With Select Advanced or Metastatic Solid Tumors

NCT0711504313 locations

Study of Sacituzumab Govitecan-hziy and Pembrolizumab Versus Treatment of Physician's Choice in Patients With Triple Negative Breast Cancer Who Have Residual Invasive Disease After Surgery and Neoadjuvant Therapy (ASCENT-05/AFT-65 OptimICE-RD/GBG 119/NSABP B-63)

NCT05633654350 locations

MEM-288 Oncolytic Virus Alone and in Combination With Standard of Care Therapy in Advanced Solid Tumors

NCT050767602 locations