Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Symptoms and General Pathology

Breast Neoplasms

Triple Negative Breast Neoplasms

Pathologic Complete Response

Breast Diseases

Skin Diseases

Antineoplastic Agents

All Drugs and Chemicals

Antirheumatic Agents

Anti-Infective Agents

Capecitabine

Paclitaxel

Cyclophosphamide

Carboplatin

Pembrolizumab

Albumin-Bound Paclitaxel

Epirubicin

Immunomodulating Agents

Taxane

Antimetabolites

Tubulin Modulators

Antimitotic Agents

Immunosuppressive Agents

Immunologic Factors

Antineoplastic Agents, Alkylating

Alkylating Agents

Antineoplastic Agents, Immunological

Immune Checkpoint Inhibitors

Anti-Bacterial Agents

Antibiotics, Antitubercular

Enzyme Inhibitors

ddEC x 4 + pembrolizumab→ PK x 4 + pembrolizumab, Two-weekly epirubicin/cyclophosphamide (EC) x 4 (epirubicin 90 mg/m2 and cyclophosphamide 600 mg/m2), followed after a three-week interval by three-weekly carboplatin x 4 (AUC = 5) together with weekly paclitaxel x 12 (80 mg/m2). Pembrolizumab is given as a 400 mg iv dosis every 6 weeks for the duration of preoperative chemotherapy.\*

CEX x 4→ PK x 4, Three-weekly cyclophosphamide/epirubicin/capecitabine (CEX) (epirubicin 75 mg/m2, cyclophosphamide 600 mg/m2 and capecitabine 900 mg/m2) x 4, followed after a three-week interval by three-weekly carboplatin x 4 (AUC = 5) together with weekly paclitaxel x 12 (80 mg/m2).Pembrolizumab is given as a 400 mg iv dosis every 6 weeks for the duration of preoperative chemotherapy.\*

\*The addition of pembrolizumab is strongly recommended to all participating patients. However, patients with a documented contraindication, or unwilling to receive immunotherapy may be included in the study without the administration of pembrolizumab.

epirubicin, cyclophosphamide, paclitaxel, carboplatin, pembrolizumab

epirubicin, cyclophosphamide, capecitabine, paclitaxel, carboplatin, pembrolizumab

Niklas Loman, MD, PhD

Lina Zander, RN

Jeanette du Pont Jensen, MD

Lone Volmer, MD

Sopie Yammeni, MD

Ulla Brix Tange, MD

Karin Peschardt, MD

Vesna Glavicic, MD

Erik Hugger Jakobsen, MD

Lars Norberg, MD, PhD

MD, PhD

Lars Norberg

Zakaria Einbeigi, MD, PhD

Per Edlund, MD, PhD

Barbro Linderholm, MD, PhD

Alaa Haidar, MD, PhD

Ida Spång Rosén, MD

Kilian Bachmeier, MD

Rosita Nordkvist, RN

Jenny Bergqvist, MD, PhD

Jenny Bergkvist, MD, PhD

Camilla Wendt, MD, PhD

Anna-Karin Wennstig, MD, PhD

Anne Andersson, MD, PhD

Henrik Lindman, MD, PhD

Cecilia Nilsson, MD, PhD

Ulrik Narbe, MD, PhD

Antonis Valachis, MD, PhD

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.

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

Distribution of different histopathological subsets of Triple Negative Breast Cancer (TNBC).

Distribution of subsets of Triple Negative Breast Cancer (TNBC) associated with different inherited breast cancer genes (BRCA1, BRCA2, PALB2, TP53, CHEK2, ATM, RAD51 C and RAD51D).

Distribution of subsets of Triple Negative Breast Cancer (TNBC) associated with somatic mutations, (Eg BRCA1, BRCA2, PALB2, TP53, and other).

Distribution of different subsets of Triple Negative Breast Cancer (TNBC) defined based on epigenetic alterations associated with silencing of BRCA1, RAD51 and related HRD-associated genes.

pCR rate in different histopathological subsets of Triple Negative Breast Cancer (TNBC).

pCR rate in subsets of Triple Negative Breast Cancer (TNBC) associated with different inherited breast cancer genes (BRCA1, BRCA2, PALB2, TP53, CHEK2, ATM, RAD51 C and RAD51D).

pCR rate in subsets of Triple Negative Breast Cancer (TNBC) associated with somatic mutations, (Eg BRCA1, BRCA2, PALB2, TP53, and other).

pCR rate in different subsets of Triple Negative Breast Cancer (TNBC) based on epigenetic alterations associated with silencing of BRCA1, RAD51 and related HRD-associated genes.

pCR rate in subsets of Triple Negative Breast Cancer (TNBC) associated with the expression of PDL1.

Rate of pathological complete response, allowing residual dcis, at surgery after preoperative chemotherapy.

Pathological complete response rate, allowing residual dcis, stratified for homologous repair deficiency.

Rate of included patients with toxicity grade 3 or greater during study treatment

Spots Global Cancer Trial Database for epirubicin, cyclophosphamide, capecitabine, paclitaxel, carboplatin, pembrolizumab