High-resolution contrast-enhanced ultrasound and biological markers to assess the response of triple-negative breast cancer during neoadjuvant chemotherapy

Not Applicable

• Conditions: Triple-negative breast cancer (TNBC); Cancer; Malignant neoplasm of breast

• Registration Number: ISRCTN85986368
• Lead Sponsor: Maidstone and Tunbridge Wells NHS Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2023-05-09
• Last Update Posted: 22 May 2023
• Study Completion: 2023-09-30

Recruitment & Eligibility

• Status: Ongoing
• Sex: Female
• Target Recruitment: 5

Inclusion Criteria

1. Provision of written informed consent
2. Biologically female aged 18 to 60 years
3. Histologically confirmed TNBC with planned NACT
4. In the investigator's opinion, adhering to the trial recommendations and governance

Exclusion Criteria

1. Cannot provide consent
2. Previous ipsilateral breast cancer with chemotherapy
3. Pregnant or breastfeeding
4. Locally advanced or inflammatory breast cancer
5. Metastatic breast cancer
6. Allergy to ultrasound contrast
7. TNBC subtype associated with good prognosis (adenoid cystic carcinoma, secretory carcinoma, acinic cell carcinoma, carcinoma with apocrine differentiation, low-grade metaplastic carcinoma and carcinoma arising in micro glandular adenosis)
8. Right to left cardiac shunt
9. Uncontrolled hypertension
10. Severe pulmonary hypertension
11. Recent thromboembolism
12. Hypercoagulation disorder
13. Adult respiratory distress syndrome

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Imaging parameters (tumour vascularity, flow velocity and distribution, complexity of vascular structures [fractal dimension], regularity of vascular flow and vessel pulsatility) assessed using the high-resolution CEUS test and compared with the results of standard imaging prior to NACT, between cycles 2 & 3 of NACT and upon completion of NACT<br>2. Immunohistochemical markers of angiogenesis, proliferation and vascular mimicry measured using standard immunohistochemistry techniques prior to NACT, between cycles 2 & 3 of NACT and upon completion of NACT

Secondary Outcome Measures

Name	Time	Method
1. Phenotypes of all cases determined using immunohistochemistry and subtype analysis prior to NACT<br>2. Germline mutations and somatic BRCA1/2 gene mutations assessed using panel sequencing prior to NACT