Laser therapy to destroy small breast cancers

Plain-English translation of NCT03463954 on ClinicalTrials.gov ↗ · Source last updated February 2026 · Translation generated June 2026 · How we translate trials

This study doesn't follow the usual testing phases — it may be an observational study or a different type of research.

What is this trial?

This trial is testing Novilase®, a type of laser therapy designed to destroy small breast cancer tumors without removing large amounts of surrounding breast tissue. The laser is guided by imaging to target the tumor precisely. After the laser procedure, doctors will check whether the tumor has been completely destroyed using imaging and then remove the treated area to confirm success.

Currently, women with small breast cancers often need surgery to remove the entire tumor along with surrounding healthy tissue. This treatment aims to offer a less invasive option that might reduce recovery time and preserve more breast tissue while still completely eliminating the cancer.

Do you qualify?

You likely qualify if…

you are 18 years or older
you have been diagnosed with a small breast cancer (15 mm or smaller) confirmed by biopsy
your tumor can be clearly seen on ultrasound or mammography imaging
your tumor is at least 5 mm away from your skin and chest wall (or can be moved that far)
you are willing to receive standard radiation or other follow-up cancer treatment as recommended by your doctor after the laser procedure

You likely don't qualify if…

you are pregnant or breastfeeding
you have a pacemaker or metallic implants that would make MRI unsafe
you have significant kidney disease or a severe allergy to contrast dye used in MRI
your tumor is larger than 15 mm or is a type of breast cancer known as triple-negative breast cancer (TNBC)
you are known to carry a BRCA gene mutation

What participation looks like

You would first have an MRI scan to confirm the tumor can be treated. Then you would receive the laser ablation procedure, guided by imaging to target your tumor. Four to six weeks later, you would return for another MRI and a surgical procedure to remove the treated area so doctors can examine it under a microscope to confirm the tumor was completely destroyed. You would then proceed with standard cancer care (radiation and/or other therapy) as your doctor recommends.

AI-generated summary from trial data · Jun 30, 2026 · Not medical advice

Trial locations(13 sites)

United States

City of Hope, Duarte, California

UC San Diego Health, La Jolla, California

Eisenhower Health, Rancho Mirage, California

Yale University, New Haven, Connecticut

Walter Reed National Military Medical Center, Bethesda, Maryland