NordicTrip, a Translational Study of Preoperative Chemotherapy in TNBC
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- STATUS
- Recruiting
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- End date
- Jun 30, 2035
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- participants needed
- 920
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- sponsor
- Lund University Hospital
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.
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.
Details
| 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 Identifier | NCT04335669 |
| Sponsor | Lund University Hospital |
| Last Modified on | 7 April 2023 |
Eligibility
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