Clinical trial · Observational
Primary and Acquired Resistance to Targeted Treatment in BRAF V600E-mutated Metastatic Colorectal Cancer
Primary and Acquired Resistance to Targeted Treatment in BRAF V600E-mutated Metastatic Colorectal Cancer (PARTACER-Suisse)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This study prospectively investigates the molecular mechanisms of primary and acquired resistance to standard-of-care BRAF V600E-directed therapy in patients with metastatic colorectal cancer and aims to pre-clinically develop novel strategies to reverse therapy resistance. Clinically approved combination treatment with cetuximab, encorafenib and chemotherapy improves patient outcomes, yet patients eventually experience disease progression. In this prospective multicenter study, tumor tissue, blood, and stool samples will be collected before treatment and at progression, to identify genetic and non-genetic mechanisms of resistance. Additionally, tumor tissue-based in vitro models (patient-derived organoids, PDOs) will be generated and exploited for functional in vitro testing, including genomic and pharmacologic perturbation studies. The overarching goal is to generate knowledge that can help develop new and more effective treatment strategies for future patients.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| BRAF V600E Mutation | — | UNRESOLVED | — |
| Metastatic Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Longitudinal translational sampling | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Patients with BRAF V600E-mutated metastatic colorectal cancer
- description
- Patients with unresectable or metastatic BRAF V600E-mutated colorectal cancer receiving standard-of-care treatment with combined BRAF and EGFR inhibition (e.g., encorafenib and cetuximab), with or without concomitant chemotherapy. Participants are enrolled prior to treatment initiation and followed longitudinally with collection of tumor tissue, blood, and stool samples to study mechanisms of treatment resistance.
- interventionNames
- Other: Longitudinal translational sampling
Primary outcomes (1)
- measure
- Detection rate of molecular alterations associated with acquired resistance
- timeFrame
- from baseline (pre-treatment) to disease progression (approximately 12 months)
- description
- Proportion of patients with detectable molecular alterations associated with acquired resistance to combined BRAF and EGFR inhibition, identified in tumor tissue collected before treatment and at disease progression using molecular profiling.
Secondary outcomes (6)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Diagnosis of unresectable or metastatic BRAF V600E-mutated colorectal cancer * Planned initiation of treatment with combined anti-EGFR antibody and BRAF inhibitor * Patients receiving treatment in any line, with or without chemotherapy * At least one tumor lesion accessible for biopsy * ECOG performance status 0-2 * Life expectancy of at least 3 months * Age ≥18 years * Ability to provide written informed consent Exclusion Criteria: * Medical or surgical contraindication for tumor biopsy * Active second malignancy (except non-melanoma skin cancer) * Inability to comply with study procedures (e.g., due to language barriers or cognitive impairment) * Pregnancy or breastfeeding * Previous treatment with a BRAF inhibitor
References
Publications (0)
Data not yet available