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Anatomic Stage III Breast Cancer AJCC v8Phase 2/3NCT04715958

SHAPE Neoadjuvant Chemotherapy Response

A Phase 2/3 study testing Contrast-Enhanced Ultrasound, Perflutren Lipid Microspheres and Ultrasound in people with Anatomic Stage III Breast Cancer AJCC v8 and Locally Advanced Breast Carcinoma, run by Kibo Nam at 3 sites in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 21 years and older, women only
What is being tested?
Contrast-Enhanced Ultrasound, Perflutren Lipid Microspheres and Ultrasound
Could I receive a placebo?
No, everyone receives an active treatment
How many people
122 participants
Where
3 sitesUnited States
Study dates
19 Apr 2021to 31 Oct 2026
Phase
Phase 2/3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 21 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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:
Show all 15Show fewer
  • 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 locations and contacts

3 sites in 1 country.

United States3 sites

  • UT Southwestern/Simmons Cancer Center-Dallas

    Dallas, Texas, 75390

  • Thomas Jefferson University Hospital

    Philadelphia, Pennsylvania, 19107

  • Mayo Clinic

    Rochester, Minnesota, 55905

Other trials in United States

About this study

Official title: Monitoring Neoadjuvant Chemotherapy of Breast Cancer Using 3D Subharmonic Aided Pressure Estimation

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.

Read the detailed description

PRIMARY OBJECTIVE:

  1. 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:

  1. 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.

Being tested
Contrast-Enhanced Ultrasound, Perflutren Lipid Microspheres, Ultrasound

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Contrast-Enhanced UltrasoundProcedure or surgery

    Also called CEUS

    Undergo CEUS

  • Perflutren Lipid MicrospheresDrug

    Also called Definity

    Given IV

  • UltrasoundProcedure or surgery

    Undergo unenhanced baseline ultrasound

Study groups in NCT04715958
Study groupRoleWhat they receive
Diagnostic (CEUS, Definity)ExperimentalPatients 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
Receives: Procedure: Contrast-Enhanced Ultrasound; Drug: Perflutren Lipid Microspheres; Procedure: Ultrasound

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Up to study completion (48 months)

  2. 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.

    Measured: Up to study completion (48 months)

  3. 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.

    Measured: Up to study completion (48 months)

Secondary outcomes (1)

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

    The variation of the accuracies of the SHAPE results by breast cancer subtypes will be reported. The generalized linear mixed effects or GEE modeling will be stratified by breast cancer subtype and also extended to include modeling of breast cancer subtype as a main effect and as an interaction effect with SHAPE.

    Measured: Up to study completion (48 months)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Jan 2021
  2. Study start19 Apr 2021
  3. Primary completion31 Oct 2026 (estimated)
  4. Study completion31 Oct 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Diagnosis
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
122 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04715958
Sponsor's protocol ID
20F.259
Other IDs
R37CA234428, JT 14825
Status last verified
Sep 2026
First submitted
14 Jan 2021
Last updated
23 Sep 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Contrast-Enhanced Ultrasound, Perflutren Lipid Microspheres and Ultrasound in people with Anatomic Stage III Breast Cancer AJCC v8 and Locally Advanced Breast Carcinoma, run by Kibo Nam at 3 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 23 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Calculation of tumor volume changes with neoadjuvant chemotherapy (NAC) (time frame: Up to study completion (48 months)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04715958.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2026.

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