NordicTrip, a Translational Study of Preoperative Chemotherapy in TNBC

  • End date
    Jun 30, 2035
  • participants needed
  • sponsor
    Lund University Hospital
Updated on 7 April 2023
growth factor
progesterone receptor
epidermal growth factor
breast adenocarcinoma
adenocarcinoma of the breast


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.


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.

Condition Breast Cancer, Triple Negative Breast Neoplasms
Treatment epirubicin, cyclophosphamide, paclitaxel, carboplatin, epirubicin, cyclophosphamide, capecitabine, paclitaxel, carboplatin, epirubicin, cyclophosphamide, paclitaxel, carboplatin, pembrolizumab, epirubicin, cyclophosphamide, capecitabine, paclitaxel, carboplatin, pembrolizumab
Clinical Study IdentifierNCT04335669
SponsorLund University Hospital
Last Modified on7 April 2023


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