VISION: Triple Negative Breast Cancer Sample and Clinical Data Acquisition Study

Launched by CONCR · May 9, 2024

Keywords

ClinConnect Summary

The VISION study is a back-in-time, observational research project that aims to improve a computer model predicting how early triple-negative breast cancer (TNBC) will respond to chemotherapy (and possibly immunotherapy). Researchers will look at up to 200 women who were previously treated for early TNBC, using their past medical records and archived tumor tissue to refine how well the model can forecast which drugs work best and how a patient’s outlook might change after treatment. No new treatments or extra biopsies are required for participation, and the study will mainly analyze existing data and samples.

Eligible participants are women aged 18 or older with stage 2 or stage 3 TNBC who had chemotherapy before surgery and have archived tissue available. There are two retrospective groups: Arm A includes those who had a complete response to chemotherapy, and Arm B includes those with remaining cancer after chemotherapy. A future Arm C may test the model’s predictions in real time. The study is taking place in the UK (Royal Marsden in London) and Australia, funded by the company Concr with UK government support, and results will be shared in academic publications. Participants should know there are no direct changes to their care as part of this study, and personal results will not be returned to individuals.

Gender

FEMALE

Eligibility criteria

• Key Inclusion Criteria:
• • Age: ≥ 18 years
• • Mental Capacity: Individual should be able to give informed consent, if alive
• • Triple Negative Breast Cancer (TNBC)
• • Oestrogen receptor (ER) negative with an Allred score of ≤ 2 or, equivalent pathology scoring system e.g., ≤10% (0 - 10%) tumour nuclei staining
• • HER2 negative: 1+ on immunohistochemistry or 2+ immunohistochemistry and FISH/D-Dish negative
• • Progesterone receptor (PgR) negative = PgR score of ≤2 or equivalent pathology scoring system e.g., ≤10% (0 - 10%) tumour nuclei staining
• • Androgen receptor (AR) status (if known): negative or positive
• • TNBC phenotype: HER2 negative tumours with borderline ER or PgR scoring on immunohistochemistry e.g., ER 3/8 and PgR 0/3 negative which were managed as early TNBC can be included but should be discussed on a case-by-case basis prior to study registration with Principal Investigator.
• • Lymph node involvement: Lymph node negative or positive; any number including clinical/pathological N3 involvement (TNM staging ≥ V.8.0)
• • Cancer Staging: Stage 2 or stage 3 breast cancer
• • Treated considered standard of care neoadjuvant chemotherapy: an anthracycline, a taxane, an alkylating agent, +/- a platinum, +/- immunotherapy
• • Available archival tissue samples
• Key Exclusion Criteria:
• • Stage IV de novo metastatic breast cancer are not eligible
• • Stage I breast cancers are not eligible
• • Women who were diagnosed with more than one cancer type within 3 years of the breast cancer diagnosis of TNBC are not eligible
• • Received neoadjuvant radiotherapy
• • Received neoadjuvant endocrine treatment
• • Women pregnant at the time of the TNBC diagnosis
• • Significant medical co-morbidities which could have influenced the participant's prognosis are excluded. Examples include cardiac failure, moderate - severe renal failure, active hepatitis, HIV, active TB, ischaemic heart disease etc.