Anatomic Stage II Breast Cancer AJCC v8Phase 2NCT07862751

US/PA/E Imaging for Early Identification of Tumor Response in Patients With Stage II-III Triple Negative Breast Cancer Receiving Neoadjuvant Immunotherapy and Chemotherapy

A Phase 2 study testing Elastography, Magnetic Resonance Imaging and Photoacoustic Imaging in people with Anatomic Stage II Breast Cancer AJCC v8 and Anatomic Stage III Breast Cancer AJCC v8, run by Emory University at 1 site in United States.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage III Breast Cancer AJCC v8, Triple-Negative Breast Carcinoma
What is being tested?: Elastography, Magnetic Resonance Imaging and Photoacoustic Imaging
Type of treatment: Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 32 participants
Where: 1 siteUnited States
Study dates: 1 Oct 2026to 31 Dec 2028
Phase: Phase 2

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 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Age ≥ 18 years
Patients with stage II-III triple negative breast cancer, per American Society of Clinical Oncology-College of American Pathologists (ASCO-CAP) guidelines
Deemed clinically appropriate for KEYNOTE-522 regimen based on performance status and laboratory findings
No signs of metastatic disease
Female patients must have a negative urine or serum pregnancy at screening (pregnancy test is not required for patients with bilateral oophorectomy and/or hysterectomy or for those patients who are > 1 year postmenopausal)
All patients of reproductive potential must agree to use an approved form of contraception
Must provide informed consent

Who cannot join

Acute bacterial or fungal infection requiring intravenous (IV) antibiotics at time of registration
Is pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the trial

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Kevin Kalinsky, MD, MS, FASCO contact

404-778-1900

kevin.michael.kalinsky@emory.edu

United States1 site

Emory University Hospital/Winship Cancer Institute
Atlanta, Georgia, 30322
Obi Ezennia, 404-778-5496, obichukwu.ezennia@emory.edu
Kevin Kalinsky, MD, MS, FASCO

Other trials in United States

About this study

Official title: Early Identification of Tumor Response in Patients With Stage II-III Triple Negative Breast Cancer Undergoing Neoadjuvant Immunotherapy With Chemotherapy

This clinical trial studies how well ultrasound/photoacoustic/elasticity (US/PA/E) imaging works for early identification of tumor response in patients with stage II-III triple-negative breast cancer receiving immunotherapy and chemotherapy before surgery (neoadjuvant). US imaging uses high-energy sound waves to look at tissues and organs inside the body. The sound waves make echoes that form pictures of the tissues and organs on a computer screen. PA imaging delivers laser light into tissue which produces ultrasonic waves which are then converted into images. Elastography (i.e., elasticity [E]) imaging uses sound waves to send vibrations into a specific organ and measures how fast those vibrations move. The vibrations move faster through areas of stiff tissue and a computer uses these measurements to make an image of those areas. Combined US/PA/E imaging using the Vevo F2 and Vevo LAZR-X20 devices may be safe and provide earlier information about tumor response to standard neoadjuvant immunotherapy and chemotherapy than current standard imaging.

Read the detailed description

PRIMARY OBJECTIVE:

To evaluate the change pattern of the US/PA/E imaging biomarkers (primarily deoxy hemoglobin) over the neoadjuvant treatment course and assess the association with clinical response as assessed by comparing baseline and presurgical magnetic resonance imaging (MRI).

SECONDARY OBJECTIVE:

To assess the ability of the US/PA/E imaging protocol to identify patient response early in the neoadjuvant treatment course of patients with stage II-III triple-negative breast cancer (TNBC) receiving neoadjuvant pembrolizumab and chemotherapy and predict pathologic complete response (pCR).

OUTLINE:

Patients undergo US imaging using the Vevo F2 device and PA/E imaging using the Vevo LAZR-X20 device prior to and at week 4 and week 7 of standard of care (SOC) carboplatin, pembrolizumab, and paclitaxel regimen, prior to cycles 1 and 2 of SOC doxorubicin, cyclophosphamide, pembrolizumab regimen, as well as prior to SOC surgery. Patients also undergo breast MRI on study.

Conditions: Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage III Breast Cancer AJCC v8, Triple-Negative Breast Carcinoma
Being tested: Elastography, Magnetic Resonance Imaging, Photoacoustic Imaging, Ultrasound Imaging, Pembrolizumab
Medical subject headings: Triple Negative Breast Neoplasms

What participants receive

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

ElastographyProcedure or surgery
Undergo PA/E imaging using the Vevo LAZR-X20 device
Magnetic Resonance ImagingProcedure or surgery
Also called Magnetic Resonance, Magnetic Resonance Imaging (MRI), Magnetic resonance imaging (procedure), Magnetic Resonance Imaging Scan
Undergo breast MRI
Photoacoustic ImagingProcedure or surgery
Undergo PA/E imaging using the Vevo LAZR-X20 device
Ultrasound ImagingProcedure or surgery
Also called 2-Dimensional Grayscale Ultrasound Imaging, 2-Dimensional Ultrasound Imaging, 2D-US, Ultrasonography
Undergo US imaging using the Vevo F2 device
PembrolizumabDrug
Also called Keytruda Qlex, MK-3475, SCH 900475, lambrolizumab
Weekly carboplatin + paclitaxel +every three- week pembrolizumab X12 weeks, followed by every three-week doxorubicin + cyclophosphamide (AC) + pembrolizumab X 4 cycles).
CarboplatinDrug
Also called Paraplatin, JM-8
Weekly carboplatin + paclitaxel +every three- week pembrolizumab X12 weeks, followed by every three-week doxorubicin + cyclophosphamide (AC) + pembrolizumab X 4 cycles).
PaclitaxelDrug
Also called BMS-181339-01, BMY-45622, Taxol
Weekly carboplatin + paclitaxel +every three- week pembrolizumab X12 weeks, followed by every three-week doxorubicin + cyclophosphamide (AC) + pembrolizumab X 4 cycles).
DoxorubicinDrug
Also called 14-hydroxy-daunomycin, Adriamycin
Weekly carboplatin + paclitaxel +every three- week pembrolizumab X12 weeks, followed by every three-week doxorubicin + cyclophosphamide (AC) + pembrolizumab X 4 cycles).
CyclophosphamideDrug
Also called Cyclophosphamid, Cytoxan
Weekly carboplatin + paclitaxel +every three- week pembrolizumab X12 weeks, followed by every three-week doxorubicin + cyclophosphamide (AC) + pembrolizumab X 4 cycles).

Study groups in NCT07862751
Study group	Role	What they receive
Diagnostic (US/PA/E)	Experimental	Patients undergo US imaging using the Vevo F2 device and PA/E imaging using the Vevo LAZR-X20 device prior to and at week 4 and week 7 of SOC carboplatin, pembrolizumab, and paclitaxel regimen, prior to cycles 1 and 2 of SOC doxorubicin, cyclophosphamide, pembrolizumab regimen, as well as prior to SOC surgery. Patients also undergo breast MRI on study. Receives: Procedure: Elastography; Procedure: Magnetic Resonance Imaging; Procedure: Photoacoustic Imaging; Procedure: Ultrasound Imaging; Drug: Pembrolizumab; Drug: Carboplatin; Drug: Paclitaxel; Drug: Doxorubicin; Drug: Cyclophosphamide

What is being measured

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

Serial changes in the ultrasound/photoacoustic/elasticity (US/PA/E) imaging biomarkers
Will evaluate serial changes in the US/PA/E imaging biomarkers (primarily deoxy hemoglobin) over the course of the treatment and their association with clinical response as assessed by comparison of baseline and pre surgical magnetic resonance imaging. Summary statistics and data visualization will be applied to describe the biomarker data at each time point, along with the changing patterns during the treatment period. A paired t-test or Wilcoxon signed rank test will test the magnitude change of optical images at week-3 from baseline. A linear and/or non-linear mixed effect model will be considered to model the longitudinal data and test the trend of change.
Measured: Baseline up to time of surgery (24 weeks)

Secondary outcomes (1)

Correlation between the early changes documented in US/PA/E protocol and the probability of achieving pathologic complete response (pCR)
Will compare the correlation between the early changes documented in US/PA/E protocol and the probability of achieving pCR, defined as pT0/T1s, pN0. To predict the status of clinical response (Aim 1) or pCR (Aim 2), the value of the biomarker at each timepoint and their change relative to the baseline value (e.g fold-change or percentage of change) will be treated as continuous variables, and receiver operator characteristics analysis will be applied to assess the overall prediction performance in terms of the area under the curve, and to identify the optimal cut-off value and/or the optimal timepoint that results in the best prediction performance in terms of the sensitivity and specificity.
Measured: Up to 24 weeks

Timeline

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

1 Oct 202631 Dec 2028

First posted7 Oct 2026
Study start1 Oct 2026 (estimated)
Primary completion31 Dec 2027 (estimated)
Study completion31 Dec 2028 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Anatomic Stage II Breast Cancer AJCC v8Studies of the same condition, open and under way.
More trials run by Emory UniversityThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

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
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 32 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07862751
Sponsor's protocol ID: 2026P000346
Other IDs: NCI-2026-06344, WINSHIP6922-26, 2026P000346, P30CA138292
Status last verified: Oct 2026
First submitted: 2 Oct 2026
Last updated: 7 Oct 2026
Results posted: No
FDA-regulated drug: Yes
FDA-regulated device: No

Interested in taking part?

Kevin Kalinsky, MD, MS, FASCO

404-778-1900

kevin.michael.kalinsky@emory.edu

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See sites and contacts

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