Spots Global Cancer Trial Database for NordicTrip, a Translational Study of Preoperative Chemotherapy in TNBC

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Trial Identification

Brief Title: NordicTrip, a Translational Study of Preoperative Chemotherapy in TNBC

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

Study ID: NCT04335669

Conditions

Breast Cancer

Triple Negative Breast Neoplasms

Interventions

epirubicin, cyclophosphamide, paclitaxel, carboplatin, pembrolizumab

epirubicin, cyclophosphamide, capecitabine, paclitaxel, carboplatin, pembrolizumab

Study Description

Brief 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.