An observational study to evaluate the prevalence of a cancer immunotherapy target and its role in patients with triple-negative breast cancer treated with systemic therapy (VANESSA)

Not Applicable

• Conditions: Triple-negative breast cancer treated with systemic therapy; Cancer; Malignant neoplasm of breast

• Registration Number: ISRCTN68770903
• Lead Sponsor: Roche (Switzerland)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-01-12
• Last Update Posted: 21 February 2022
• Study Completion: 2022-09-30

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 2700

Inclusion Criteria

1. Signed Informed Consent Form, if and as required, according to local laws and regulations
2. Aged =18 years at the time of diagnosis
3. Histologically documented TNBC, assessed locally and defined as ER and PR positivity of less than 1% and HER2 IHC0, IHC1+, or IHC2+/ISH-, as determined according to ASCO/CAP guidelines
4. New diagnosis of eTNBC (early or locoregionally advanced TNBC, amenable to treatment with curative intent) or mTNBC (metastatic or locoregionally advanced unresectable TNBC, not amenable to treatment with curative intent) between 1st January 2014 and 31st December 2017
5. Available formalin-fixed paraffin-embedded (FFPE) tumor tissue of good quality based on total and viable tumor content for local and central laboratory PD-L1 testing
6. Documentation of tissue source (primary breast cancer, de novo breast cancer, metastatic tumor location), biopsy or resection, tissue size and tumor content
7. Patients who received any systemic therapy in early-stage disease and/or in metastatic setting
8. Only patients with documented, locally determined PD-L1 status using Ventana PD-L1 (SP142) assay by trained pathologists, will be eligible for central testing and their data will be included in the study analysis

Exclusion Criteria

1. No available archival tumor tissue for PD-L1 testing
2. Tissue samples of poor quality based on total and viable tumor content and/or bad fixation
3. Fine needle aspiration, brushing, cell pellet from pleural effusion, bone metastases, and lavage samples are not acceptable
4. Patients whose tumor tissue is not evaluable for local and central testing

Study & Design

• Study Type: Observational
• Study Design: Not specified