NCT04335669

NordicTrip, a Translational Study of Preoperative Chemotherapy in TNBC

A Translational Randomized Phase III Study Exploring the Effect of the Addition of Capecitabine to Carboplatine Based Chemotherapy in Early "Triple Negative" Breast Cancer

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 325 (estimated)
• Sponsor: Lund University Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

Primary aim: To compare the effect on pathologic complete response (pCR) rate of adding capecitabine to carboplatin based preoperative chemotherapy in early ER-negative and HER2-negative breast cancer. Pembrolizumab is allowed in both arms after approval for TNBC 2022.

Detailed description

Primary aim: Pathological complete response rate after preoperative chemotherapy is the primary end-point of the study, which will be evaluated by comparing the effects of neoadjuvant administration of a carboplatin-based treatment and treatment adding capecitabine on pCR. After the approval of pembrolizumab in the preoperative treatment of early TNBC in 2022 the study will consist of two cohorts, one (cohort 1) without the addition of pembrolizumab, and one (cohort 2) with the addition of pembrolizumab to both study arms. The primary evaluation will be performed on the entire study population including both cohorts. Primary translational aim: To investigate if the effects of the treatments depend on homologous repair deficiency (HRD)-status. More specifically, the aim is to test for differential effect of the two treatments on pCR for HRD-negative (HRD low and intermediate by oncoscan) and HRD-positive (HRD high by oncoscan) patients.

Conditions

• Breast Cancer
• Triple Negative Breast Neoplasms

Interventions

Type	Name	Description
DRUG	epirubicin, cyclophosphamide, paclitaxel, carboplatin, pembrolizumab	Cytotoxic agents.
DRUG	epirubicin, cyclophosphamide, capecitabine, paclitaxel, carboplatin, pembrolizumab	Cytotoxic agents.

Timeline

• Start date: 2019-12-20
• Primary completion: 2035-09-01
• Completion: 2035-09-01
• First posted: 2020-04-06
• Last updated: 2025-09-12

Locations

24 sites across 2 countries: Denmark, Sweden