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Nab-paclitaxel Plus Carboplatin Versus Nab-paclitaxel Plus Epirubicin in the Neoadjuvant Therapy for Breast Cancer | Clinical Trials | Clareo Health

RECRUITINGPHASE2

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

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

NCT04138719•Hebei Medical University Fourth Hospital

View on ClinicalTrials.gov

Summary

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.

Eligibility

Age

18 - 70 years

Sex

FEMALE

Healthy Volunteers

Inclusion Criteria

•1. Females with age between 18 to 70 years old;
•2. Histologically confirmed primary invasive breast cancer;
•3. Histologically confirmed triple negative breast cancer;
•4. Patients who planned to accept preoperative neoadjuvant therapy and had a mass larger than 2 cm.
•5. Blood specimens and 5 sections of tumor tissue at baseline, blood specimens at surgery can be obtained.
•6. Have at least one measurable lesion as per the RECIST criteria (version 1.1);
•7. Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to one;
•8. LVEF≥55%；
•9. Bone marrow function：neutrophils (≥1.5×10\^9/L), platelets (≥100×10\^9/L), hemoglobin (≥90 g/L);
•10. Renal and hepatic function: Serum creatinine≤ 1.5×institutional upper limit of normal (ULN); AST and ALT ≤ 2.5 × ULN; Total bilirubin≤1.5×ULN, or patients with Gilbert's syndrome ≤ 2.5 × ULN;
+1 more criteria

Exclusion Criteria

•1. Previous treatment with any cytotoxic chemotherapy, endocrine therapy, biotherapy or radiotherapy;
•2. Patients with heart disease above grade II (including grade II) identified by New York Heart Association (NYHA) scores;
•3. Patients with severe systemic infection or other serious diseases;
•4. Patients allergic to or intolerant of chemotherapeutic drugs or their adjuvants;
•5. Patients with other malignant tumors in the past five years, except for cured cervical carcinoma in situ and non-melanoma skin cancer;
•6. Pregnancy or lactation, as well as reproductive age patients who refused to take appropriate contraceptive measures in the trial;
•7. Participation in any trial drug treatment or another interventional clinical trial 30 days before first dose was given;
•8. The researchers considered the patients who were not suitable for enrollment.

Locations (1)

The Fourth Hospital of Hebei Medical University

Shijiazhuang, Hebei, China

Key Dates

Start Date

November 20, 2019

Primary Completion Date

October 20, 2026

Completion Date

June 20, 2028

Last Updated

September 11, 2025

Enrollment

520

ESTIMATED participants

Conditions

Breast CancerTriple-negative Breast CancerNab-paclitaxel

Interventions

Nab-paclitaxel + Carboplatin

DRUG

Nab-paclitaxel + Epirubicin

DRUG

Contacts

Cuizhi Geng, M.D.

CONTACT

0311-6669 6310 gengcuizhi@hotmail.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 11, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

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