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NOT YET RECRUITING
NCT07862751
PHASE2

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

Sponsor: Emory University

View on ClinicalTrials.gov

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). 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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

32

Start Date

2026-10-01

Completion Date

2028-12-31

Last Updated

2026-10-07

Healthy Volunteers

No

Interventions

PROCEDURE

Elastography

Undergo PA/E imaging using the Vevo LAZR-X20 device

PROCEDURE

Magnetic Resonance Imaging

Undergo breast MRI

PROCEDURE

Photoacoustic Imaging

Undergo PA/E imaging using the Vevo LAZR-X20 device

PROCEDURE

Ultrasound Imaging

Undergo US imaging using the Vevo F2 device

DRUG

Pembrolizumab

Weekly carboplatin + paclitaxel +every three- week pembrolizumab X12 weeks, followed by every three-week doxorubicin + cyclophosphamide (AC) + pembrolizumab X 4 cycles).

DRUG

Carboplatin

Weekly carboplatin + paclitaxel +every three- week pembrolizumab X12 weeks, followed by every three-week doxorubicin + cyclophosphamide (AC) + pembrolizumab X 4 cycles).

DRUG

Paclitaxel

Weekly carboplatin + paclitaxel +every three- week pembrolizumab X12 weeks, followed by every three-week doxorubicin + cyclophosphamide (AC) + pembrolizumab X 4 cycles).

DRUG

Doxorubicin

Weekly carboplatin + paclitaxel +every three- week pembrolizumab X12 weeks, followed by every three-week doxorubicin + cyclophosphamide (AC) + pembrolizumab X 4 cycles).

DRUG

Cyclophosphamide

Weekly carboplatin + paclitaxel +every three- week pembrolizumab X12 weeks, followed by every three-week doxorubicin + cyclophosphamide (AC) + pembrolizumab X 4 cycles).

Locations (1)

Emory University Hospital/Winship Cancer Institute

Atlanta, Georgia, United States