Identifying biomarkers for treatment response in triple negative breast cancer
Identification of Predictive Biomarkers of Response to Chemotherapy and Immune Checkpoint Inhibitors in Early Triple Negative Breast Cancer: an Integrative Multiomics Platform
This study is testing if certain biological markers in tissue samples can help doctors predict how well treatments will work for people with stage II-III triple negative breast cancer.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Vall d'Hebron Institute of Oncology Academic / other |
| Drugs / interventions | chemotherapy, pembrolizumab |
| Locations | 1 site (Barcelona) |
| Trial ID | NCT05916755 on ClinicalTrials.gov |
What this trial studies
This observational study focuses on patients with stage II-III triple negative breast cancer (TNBC) who are candidates for neoadjuvant chemotherapy, with or without immune checkpoint inhibitors. It aims to analyze various tissue samples using multiomics approaches, including whole genome sequencing and microbiome analysis, to establish predictive biomarkers of treatment response. The study will integrate data from these analyses to develop a clinical tool that assists clinicians in making informed treatment decisions for TNBC patients.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with histologically confirmed stage II-III triple negative breast cancer who are eligible for neoadjuvant chemotherapy.
Not a fit: Patients with metastatic disease or those not eligible for neoadjuvant chemotherapy will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to personalized treatment strategies that improve outcomes for patients with triple negative breast cancer.
How similar studies have performed: Other studies have shown promise in using multiomics approaches to identify biomarkers in cancer treatment, suggesting potential success for this novel approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Exclusion Criteria: * Metastatic disease on imaging (stage 4)
Where this trial is running
Barcelona
- Vall d'Hebron Institute of Oncology — Barcelona, Spain (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.