Phase II Study on Personalized Radiation and Sentinel Lymph Node Biopsy for Early-stage ER+ Breast Cancer

Sponsor: University of Texas Southwestern Medical Center

Sponsor score: 40

ClinicalTrials ID:NCT06444269

Provider View

This clinical trial is exploring a new approach to treating early-stage estrogen receptor-positive breast cancer using personalized radiation therapy before surgery and a non-surgical method to check lymph nodes.

Patient Parameters

Program Overview

The study aims to test the effectiveness of a personalized radiation treatment called PULSAR before surgery in patients with early-stage estrogen receptor-positive (ER+) breast cancer. It also evaluates a new method using microbubble contrast-enhanced ultrasound (CEUS) to check lymph nodes without surgery and assesses how well the treatment works on the tumor.

Eligibility Criteria

Inclusion Criteria

  • Women aged 18 or older with specific types of early-stage breast cancer (tumor size 3 cm or less) who have not had surgery or chemotherapy for their current diagnosis.
  • Tumor must not affect the skin and should be visible on scans or marked with clips.
  • Must undergo an MRI to help define the tumor and rule out other disease areas.
  • Lymph nodes must appear normal on initial scans.
  • Tumor must be estrogen or progesterone receptor-positive and HER2-negative.
  • Must understand and agree to sign a consent form.
  • Women of childbearing potential must use effective birth control during the study.
  • If a biopsy clip is placed in the lymph node, further biopsy and clip placement is at the investigator's discretion.

Exclusion Criteria

  • Cancer in multiple areas of the breast.
  • Previous radiation to the affected breast.
  • Tumor larger than 3 cm.
  • Pregnant or breastfeeding women due to potential risks from radiation.
  • Previous breast cancer on the same side.
  • Active lupus or scleroderma.
  • Allergic reactions to similar substances used in the study.
  • Positive lymph node at the time of microbubble ultrasound.

Locations

FACILITYZIPCITYSTATE
UT Southwestern Medical Center-Dallas75390DallasTexas

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