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Not Yet Recruiting NCT07862751

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

Conditions: Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage III Breast Cancer AJCC v8, Triple-Negative Breast Carcinoma

Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: PHASE2
Enrollment: 32
Sponsor: Emory University

Location: Emory University Hospital/Winship Cancer Institute Atlanta Georgia

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.

Eligibility Criteria

Inclusion Criteria: * 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 Exclusion Criteria: * 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

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07862751). StuddyBuddy aggregates publicly available trial information.