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

Kibo Nam

Status and phase: Enrolling; Phase 3; Phase 2

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

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

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04715958

JT 14825 (Other Identifier)

R37CA234428 (U.S. NIH Grant/Contract)

20F.259

Details and patient eligibility

About

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.

Full description

PRIMARY OBJECTIVE:

I. To apply and evaluate a novel biomarker from 3-dimensional subharmonic aided pressure estimation (3D SHAPE) to predict neoadjuvant chemotherapy (NAC) response in patients with breast cancer.

SECONDARY OBJECTIVE:

I. To assess whether the accuracy of 3D SHAPE for predicting locally advanced breast cancer (LABC) NAC response varies with breast cancer subtype.

OUTLINE:

Patients undergo contrast-enhanced ultrasound (CEUS) and receive perflutren lipid microspheres intravenously (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.

After completion of study, patients are followed up at the completion of NAC.

Enrollment: 200 estimated patients

Sex: Female

Ages: 21+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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200 participants in 1 patient group

Diagnostic (CEUS, Definity)

Experimental group

Description:

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

Treatment:

Procedure: Contrast-Enhanced Ultrasound

Procedure: Ultrasound

Drug: Perflutren Lipid Microspheres