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NordicTrip, a Translational Study of Preoperative Chemotherapy in TNBC

NCT04335669 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 325

Last updated 2025-09-12

No results posted yet for this study

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.

Conditions

Interventions

DRUG

epirubicin, cyclophosphamide, paclitaxel, carboplatin, pembrolizumab

Cytotoxic agents.

DRUG

epirubicin, cyclophosphamide, capecitabine, paclitaxel, carboplatin, pembrolizumab

Cytotoxic agents.

Sponsors & Collaborators

  • Swedish Breast Cancer Group

    collaborator OTHER

  • Danish Breast Cancer Cooperative Group

    collaborator OTHER

  • Lund University Hospital

    lead OTHER

Principal Investigators

  • Niklas Loman, MD, PhD · Lund University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-12-20
Primary Completion
2035-09-30
Completion
2035-09-30

Countries

  • Denmark
  • Sweden

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04335669 on ClinicalTrials.gov