Clinical trial NCT04715958: Prediction of Neoadjuvant Chemotherapy Response Using Contrast-Enhanced Ultrasound in Patients With Locally Advanced Breast Cancer
Official title: Monitoring Neoadjuvant Chemotherapy of Breast Cancer Using 3D Subharmonic Aided Pressure Estimation
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
PHASE3
Conditions: Anatomic Stage III Breast Cancer AJCC v8
Locally Advanced Breast Carcinoma
Lead sponsor: Thomas Jefferson University
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2021-01-20
Enrollment: 200
Sex: FEMALE
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Calculation of tumor volume changes with neoadjuvant chemotherapy (NAC)
timeFrame: Up to study completion (48 months)
measure: Prediction of the patients' clinical and pathological response
timeFrame: Up to study completion (48 months)
measure: The ability of the SHAPE method to distinguish responders from non-responders
timeFrame: Up to study completion (48 months)
Secondary outcomes:
measure: Accuracy of the 3D SHAPE for predicting locally advanced breast cancer NAC response varies with breast cancer subtype
timeFrame: Up to study completion (48 months)
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Philadelphia
country: United States
facility: Thomas Jefferson University Hospital
state: Pennsylvania
city: Dallas
country: United States
facility: UT Southwestern/Simmons Cancer Center-Dallas
state: Texas
Study officials:
affiliation: Thomas Jefferson University
name: Kibo Nam, MD
role: PRINCIPAL_INVESTIGATOR
References: