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.
Trial summary
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). Read more about this study
- 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 Jan 2027to 31 Dec 2028
- Phase
- Phase 2
- 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 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.
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
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 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.
- First posted7 Oct 2026
- Study start1 Jan 2027 (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)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Kevin Kalinsky, Emory University
- Investigators
- Kevin Kalinsky, MD, MS, FASCO, Principal investigator, Emory University Hospital/Winship Cancer Institute
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
- Nov 2026
- First submitted
- 2 Oct 2026
- Last updated
- 4 Nov 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Identification of Tumor Response in Patients With Stage II-III Triple Negative Breast Cancer Undergoing Neoadjuvant Immunotherapy With Chemotherapy
- ClinicalTrials.gov ID
- NCT07862751
- Acronym / sponsor ID
- 2026P000346
- Conditions
- Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage III Breast Cancer AJCC v8, Triple-Negative Breast Carcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 1 Jan 2027 (estimated)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 7 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Diagnostic (US/PA/E) | Experimental | Procedure: Elastography, Procedure: Magnetic Resonance Imaging, Procedure: Photoacoustic Imaging, Procedure: Ultrasound Imaging, Drug: Pembrolizumab, Drug: Carboplatin, Drug: Paclitaxel, Drug: Doxorubicin, Drug: CyclophosphamidePatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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)
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ElastographyUndergo PA/E imaging using the Vevo LAZR-X20 device | Procedure or surgery | Diagnostic (US/PA/E) |
| Magnetic Resonance ImagingAlso: Magnetic Resonance, Magnetic Resonance Imaging (MRI), Magnetic resonance imaging (procedure), Magnetic Resonance Imaging ScanUndergo breast MRI | Procedure or surgery | Diagnostic (US/PA/E) |
| Photoacoustic ImagingUndergo PA/E imaging using the Vevo LAZR-X20 device | Procedure or surgery | Diagnostic (US/PA/E) |
| Ultrasound ImagingAlso: 2-Dimensional Grayscale Ultrasound Imaging, 2-Dimensional Ultrasound Imaging, 2D-US, UltrasonographyUndergo US imaging using the Vevo F2 device | Procedure or surgery | Diagnostic (US/PA/E) |
| PembrolizumabAlso: Keytruda Qlex, MK-3475, SCH 900475, lambrolizumabWeekly carboplatin + paclitaxel +every three- week pembrolizumab X12 weeks, followed by every three-week doxorubicin + cyclophosphamide (AC) + pembrolizumab X 4 cycles). | Drug | Diagnostic (US/PA/E) |
| CarboplatinAlso: Paraplatin, JM-8Weekly carboplatin + paclitaxel +every three- week pembrolizumab X12 weeks, followed by every three-week doxorubicin + cyclophosphamide (AC) + pembrolizumab X 4 cycles). | Drug | Diagnostic (US/PA/E) |
| PaclitaxelAlso: BMS-181339-01, BMY-45622, TaxolWeekly carboplatin + paclitaxel +every three- week pembrolizumab X12 weeks, followed by every three-week doxorubicin + cyclophosphamide (AC) + pembrolizumab X 4 cycles). | Drug | Diagnostic (US/PA/E) |
| DoxorubicinAlso: 14-hydroxy-daunomycin, AdriamycinWeekly carboplatin + paclitaxel +every three- week pembrolizumab X12 weeks, followed by every three-week doxorubicin + cyclophosphamide (AC) + pembrolizumab X 4 cycles). | Drug | Diagnostic (US/PA/E) |
| CyclophosphamideAlso: Cyclophosphamid, CytoxanWeekly carboplatin + paclitaxel +every three- week pembrolizumab X12 weeks, followed by every three-week doxorubicin + cyclophosphamide (AC) + pembrolizumab X 4 cycles). | Drug | Diagnostic (US/PA/E) |
Primary outcome
Serial changes in the ultrasound/photoacoustic/elasticity (US/PA/E) imaging biomarkers
Time frame: Baseline up to time of surgery (24 weeks)
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.
1 secondary outcome
Correlation between the early changes documented in US/PA/E protocol and the probability of achieving pathologic complete response (pCR)
Time frame: Up to 24 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2026.
Related trials for Anatomic Stage II Breast Cancer AJCC v8
RecruitingPhase 3
Testing Whether Hormone Therapy With Ribociclib is as Effective as Chemotherapy Followed by Hormone Therapy With Ribociclib for the Treatment of High Anatomic Stage Breast Cancer With Low Recurrence Risk, The RxFINE-Low Trial
Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8
RecruitingPhase 3
Adding an Immunotherapy Drug, MEDI4736 (Durvalumab), to the Usual Chemotherapy Treatment (Paclitaxel, Cyclophosphamide, and Doxorubicin) for Stage II-III Breast Cancer
Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage III Breast Cancer AJCC v8
Active, not recruitingPhase 2
Measuring the Effects of Talazoparib in Patients With Advanced Cancer and DNA Repair Variations
Anatomic Stage III Breast Cancer AJCC v8, Anatomic Stage IV Breast Cancer AJCC v8
RecruitingObservational study
Collecting Blood Samples From Patients With and Without Cancer to Evaluate Tests for Early Cancer Detection
Acute Lymphoblastic Leukemia, Acute Myeloid Leukemia
RecruitingPhase 2
Dose-Reduced Docetaxel With Cyclophosphamide for the Treatment of Vulnerable Older Women With Stage I-III HER2 Negative Breast Cancer, the DOROTHY Trial
Anatomic Stage I Breast Cancer AJCC v8, Anatomic Stage II Breast Cancer AJCC v8
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Kevin Kalinsky, MD, MS, FASCO principal investigator
Emory University Hospital/Winship Cancer Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
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.
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 7 inclusion and 2 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: opening soon, as of the sponsor's last update on 4 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 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.
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?
Contact Kevin Kalinsky, MD, MS, FASCO (404-778-1900, kevin.michael.kalinsky@emory.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serial changes in the ultrasound/photoacoustic/elasticity (US/PA/E) imaging biomarkers (time frame: Baseline up to time of surgery (24 weeks)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Nov 2026.