NCT05916755 Predictive Biomarkers of Response to Checkpoint Inhibitors in Triple Negative Breast Cancer: a Multiomics Platform
| NCT ID | NCT05916755 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Vall d'Hebron Institute of Oncology |
| Condition | Triple Negative Breast Cancer |
| Study Type | OBSERVATIONAL |
| Enrollment | 100 participants |
| Start Date | 2023-01-13 |
| Primary Completion | 2026-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 100 participants in total. It began in 2023-01-13 with a primary completion date of 2026-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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)
Frequently Asked Questions
Who can join the NCT05916755 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Triple Negative Breast Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05916755 currently recruiting?
Yes, NCT05916755 is actively recruiting participants. Visit ClinicalTrials.gov or contact Vall d'Hebron Institute of Oncology to inquire about joining.
Where is the NCT05916755 trial being conducted?
This trial is being conducted at Barcelona, Spain.
Who is sponsoring the NCT05916755 clinical trial?
NCT05916755 is sponsored by Vall d'Hebron Institute of Oncology. The trial plans to enroll 100 participants.
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