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Nab-paclitaxel Plus Carboplatin Versus Nab-paclitaxel Plus Epirubicin in the Neoadjuvant Therapy for Breast Cancer

StatusRecruiting
PhasePhase 2
Started2019-11-20
View on ClinicalTrials.gov ↗

Amendment history

2025-09-10
Study Status, Oversight, IPDSharing v2
Primary completion date2020-10-20→2026-10-20
Completion date2021-06-20→2028-06-20
2019-11-07
Study Status v1
Start date2019-10-20→2019-11-20
2019-10-23
Original filing
This is a multicenter, open, randomized, comparison study. Triple-negative breast cancer (TNBC) is a term applied to breast cancer cases that have \<1% expression of the estrogen receptor (ER) and the progesterone receptor (PR) and do not over express HER2. Neoadjuvant therapy is often used to reduce the size of tumors, especially in locally advanced tumors. The purpose of this therapy is to make part of patients operable and to facilitate breast-conserving surgery. The purpose of this study is to assess the efficacy and safety of the following two proposals: nab-paclitaxel plus carboplatin versus nab-paclitaxel plus epirubicin, in order to provide support for rational clinical application. The total number of patients to be included in this study is 520 patients.
Trial Details
NCT Number NCT04138719
Lead Sponsor Hebei Medical University Fourth Hospital
Collaborators: Beijing 302 Hospital, CSPC Ouyi Pharmaceutical Co., Ltd.
Conditions Breast Cancer, Triple-negative Breast Cancer, Nab-paclitaxel
Enrollment 520 participants
Start Date 2019-11-20
Primary Completion 2026-10-20 (estimated)
Study Completion 2028-06-20 (estimated)
Updated on ClinicalTrials.gov 2025-09-11