Clinical Perspectives

New Clinical Trial Aims to Genomically Personalize Radiation Therapy for Breast Cancer

February 14, 2023

Breast Cancer Radiology 640

Moffitt Cancer Center stays on the cutting edge of cancer therapies. Our breast cancer patients have access to the latest treatments and technologies that improve the effectiveness of therapies, minimize invasiveness and conserve healthy breast tissue.

In a new clinical trial led by principal investigator Dr. Kamran Ahmed, Moffitt breast oncologists are testing the feasibility of an in-house developed radiation signature for the first time. The actively enrolling clinical trial explores a new form of genomically guided radiation therapy (RT) to treat triple-negative breast cancer following breast conservation surgery.

Current Standard of Care for Triple Negative Breast Cancer Patients

Triple-negative breast cancer accounts for 10-15% of all breast cancer cases and is characterized by the absence of three hormone receptors—estrogen, progesterone, and the HER2 protein—normally found in healthy breast cells.

Due to the lack of these hormone receptors, hormone-based therapy and HER2-targeted therapy is ineffective for triple-negative breast cancer. Following breast conservation surgery, radiation therapy is the standard treatment. The current standard of care is to deliver radiation therapy dosing in a one-size-fits-all approach. This could mean that some tumors are treated with not enough radiation while others are treated with too much radiation.

Understanding Genomically Guided Radiation and its Benefits

Within breast cancer, there is a spectrum of tumor biology doctors can measure to inform radiation dose and maximize its clinical efficacy. Moving away from a one-size-fits-all approach, cancer care teams are customizing radiotherapy for triple-negative breast cancer patients using these unique tumor biomarkers to determine the corresponding radiation dose prescription.

The current clinical trial seeks to tailor radiation therapy to the unique biology of the tumor using genomically guided treatment.

Clinical Trial Goals and Enrollment

Dr. Ahmed’s phase 2 trial aims to determine the feasibility of genomically guided RT in patients with triple-negative breast cancer undergoing breast conservation therapy. Using Moffitt’s gene expression-based radiosensitivity index (RSI), patient tumor tissue is tested to calculate the risk of cancer recurrence and determine the amount of RT patients should receive following breast conservation therapy.

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"This is the first clinical trial to use the radiation sensitivity index (RSI) to tailor radiation therapy dose using the unique genomics of the tumor. This radiation signature has been in development for the past two decades at Moffitt and we are excited to now offer tailored radiation therapy using the RSI signature."

- Dr. Kamran Ahmed, MD, Radiation Oncology

Important clinical trials such as this study, advance treatments and improve patient outcomes. Moffitt’s outcomes are up to four times higher than national averages due in part to groundbreaking studies expanding options and increasing the efficacy of cancer treatments. Our triple-negative breast cancer specialists hope to use genomically guided RT to continue improving patient results.

Healthcare providers can recommend this clinical trial to recently diagnosed triple-negative breast cancer patients who are undergoing breast conservation therapy and meet eligibility criteria, ( identifier NCT05528133).

If you'd like to refer a patient to Moffitt Cancer Center, complete our online form or contact a physician liaison for assistance.