Prediction of Neoadjuvant Chemotherapy Response Using Contrast-Enhanced Ultrasound in Patients With Locally Advanced Breast Cancer

NCT04715958 | Recruiting Phase 2 DMC FDA Drug

• 3 other identifiers: 20F.259R37CA234428JT 14825
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 3

Brief Summary

This phase II/III trial studies if contrast-enhanced ultrasounds using a contrast dye, perflutren lipid microspheres (Definity), can predict the response to chemotherapy by estimating the pressure in the cancer in patients with breast cancer that has spread to nearby tissues and lymph nodes (locally advanced). The efficacy of cancer therapy is affected by the pressure in the cancer. Definity is a contrast dye used to create better images during ultrasounds. The purpose of this trial is to determine if a special kind of ultrasound, called contrast-enhanced ultrasound, an experimental imaging test, can detect pressures in cancer to determine the response to neoadjuvant chemotherapy in patients with breast cancer.

Conditions

Anatomic Stage III Breast Cancer AJCC v8; Locally Advanced Breast Carcinoma

Outcome Measures

Primary Outcomes (3)

• Calculation of tumor volume changes with neoadjuvant chemotherapy (NAC)

  3-dimensional (3D) tumor measurements over the three ultrasound exams will be recorded for each subject to calculate tumor volume changes with NAC. The tumor volume change during the therapy will be compared to imaging (magnetic resonance imaging or ultrasound) and pathologic response as well as to the corresponding 3D subharmonic aided pressure estimation (SHAPE) results.

  Up to study completion (48 months)

• Prediction of the patients' clinical and pathological response

  The SHAPE results from three time points (i.e. before, 10% completion, and 30% completion of NAC) will be modeled for predicting the patients' clinical response as well as pathological response using longitudinal logistic regression with adjustment for correlated observations over time by generalized linear mixed effects or generalized estimating equations (GEE) modeling.

  Up to study completion (48 months)

• The ability of the SHAPE method to distinguish responders from non-responders

  Will also be compared using receiver operating characteristic analysis to develop thresholds for decision-making based on balancing sensitivity and specificity.

  Up to study completion (48 months)

Secondary Outcomes (1)

• Accuracy of the 3D SHAPE for predicting locally advanced breast cancer NAC response varies with breast cancer subtype

  Up to study completion (48 months)

Study Arms (1)

Diagnostic (CEUS, Definity)

EXPERIMENTAL

Patients undergo CEUS and receive perflutren lipid microspheres IV over 10-15 minutes before NAC, after 10% of NAC, and after 30% of NAC. Patients also undergo unenhanced baseline ultrasound imaging before NAC, after 10% of NAC, after 30% of NAC, and after 100% of NAC

Procedure: Contrast-Enhanced Ultrasound; Drug: Perflutren Lipid Microspheres; Procedure: Ultrasound

Interventions

Contrast-Enhanced Ultrasound PROCEDURE

Undergo CEUS

Also known as: CEUS

Diagnostic (CEUS, Definity)

Perflutren Lipid Microspheres DRUG

Given IV

Also known as: Definity

Diagnostic (CEUS, Definity)

Ultrasound PROCEDURE

Undergo unenhanced baseline ultrasound

Diagnostic (CEUS, Definity)

Eligibility Criteria

• Age: 21 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Provide signed and dated informed consent form
• Willing to comply with all study procedures and be available for the duration of the study
• At least 21 years old
• Be diagnosed with breast cancer (T1 or greater LABC, any N and M0)
• Be scheduled for neoadjuvant chemotherapy
• Be medically stable
• Be conscious and able to comply with study procedures
• If a female of child-bearing potential, must have a negative urine pregnancy test

You may not qualify if:

• Males
• Females who are pregnant or nursing
• Patients with other primary cancers requiring systemic treatment
• Patients with any distal metastatic disease
• Patients undergoing neoadjuvant endocrine therapy
• Patients who are medically unstable, patients who are seriously or terminally ill, and patients whose clinical course is unpredictable. For example:
• Patients on life support or in a critical care unit;
• Patients with unstable occlusive disease (e.g., crescendo angina);
• Patients with clinically unstable cardiac arrhythmias, such as recurrent ventricular tachycardia;
• Patients with uncontrolled congestive heart failure (New York Heart Association \[NYHA\] Class IV);
• Patients with recent cerebral hemorrhage;
• Patients who have undergone surgery within 24 hours prior to the study sonographic examination
• Patients with known hypersensitivity or allergy to any component of Definity
• Patients with unstable cardiopulmonary conditions or respiratory distress syndrome
• Patients with uncontrollable emphysema, pulmonary vasculitis, pulmonary hypertension or a history of pulmonary emboli

Sponsors & Collaborators

• Kibo Nam: lead
• National Cancer Institute (NCI): collaborator

Study Sites (3)

Mayo Clinic

Rochester, Minnesota, 55905, United States

NOT YET RECRUITING

Thomas Jefferson University Hospital

Philadelphia, Pennsylvania, 19107, United States

RECRUITING

UT Southwestern/Simmons Cancer Center-Dallas

Dallas, Texas, 75390, United States

RECRUITING

MeSH Terms

Interventions

perflutren; High-Energy Shock Waves

Intervention Hierarchy (Ancestors)

Ultrasonic Waves; Sound; Radiation, Nonionizing; Radiation; Physical Phenomena

Study Officials

• Kibo Nam, MD

  Thomas Jefferson University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kibo Nam, MD

CONTACT

215-955-6261; Kibo.Nam@jefferson.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 14, 2021
• First Posted: January 20, 2021
• Study Start: December 7, 2020
• Primary Completion (Estimated): May 31, 2026
• Study Completion (Estimated): May 31, 2026
• Last Updated: February 17, 2026

Record last verified: 2026-02

Locations

US (3)