Identification of Predictive Biomarkers of Response to Chemotherapy and Immune Checkpoint Inhibitors in Early Triple Negative Breast Cancer: an Integrative Multiomics Platform

Status: Recruiting
Location: See location...
Intervention Type: Diagnostic test, Drug
Study Type: Observational
SUMMARY

Patients with stage II-III Triple negative breast cancer (TNBC) candidates to receive neoadjuvant chemotherapy (NACT) +/- immune checkpoint inhibitor (ICI) will be included. Several samples from different tissues will be analyzed through different omics to establish predictive biomarkers of response to the treatment. Multiple algorithms will then be used to look for an integrative predictive algorithm that incorporates multi-parameter inputs in order to develop a clinical tool to assist clinicians in the process of treatment decision-making in TNBC.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Histologically documented TNBC (negative human epidermal growth factor receptor 2 \[HER2\], estrogen receptor \[ER\], and progesterone receptor \[PgR\] status)

• Stage 2 - 3 defined by the American Joint Committee of Cancer (AJCC) staging criteria 8th edition for breast cancer as assessed by the investigator based on radiological and/or clinical assessment

• Patient is a candidate to receive NACT with or without ICI as assessed by the investigator

• Patient is ≥ 18 years old at the time of consent to participate in this trial

Locations
Other Locations
Spain
Vall d'Hebron Institute of Oncology
RECRUITING
Barcelona
Time Frame
Start Date: 2023-01-13
Estimated Completion Date: 2029-12
Participants
Target number of participants: 100
Treatments
Cohort A
Pembrolizumab + neoadjuvant chemotherapy
Cohort B
Neoadjuvant chemotherapy
Sponsors
Leads: Vall d'Hebron Institute of Oncology

This content was sourced from clinicaltrials.gov