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RECRUITING
NCT04136782
PHASE4

Albumin-bound Paclitaxel and Carboplatin Versus Epirubicin and Docetaxel for Triple-negative Breast Cancer

Sponsor: Shengjing Hospital

View on ClinicalTrials.gov

Summary

To investigate the efficacy of albumin-bound paclitaxel combined with carboplatin versus epirubicin combined with docetaxel as neoadjuvant therapy for triple-negative breast cancer.

Official title: Albumin-bound Paclitaxel Combined With Carboplatin Versus Epirubicin Combined With Docetaxel as Neoadjuvant Therapy for Triple-negative Breast Cancer: a Multicenter Randomized Controlled Phase IV Clinical Trial

Key Details

Gender

FEMALE

Age Range

18 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

110

Start Date

2021-07-19

Completion Date

2026-11-30

Last Updated

2021-07-20

Healthy Volunteers

No

Conditions

Interventions

DRUG

Albumin-bound paclitaxel combined with carboplatin

Albumin-bound paclitaxel combined with carboplatin: Albumin-bound paclitaxel (Abraxis BioScience, LLC., Mclrose Park, IL, USA; certificate number: H20091059) will be intravenously administered at 125 mg/m2 for 30 minutes on days 1 and 8 of each 21-day session of treatment. There will be six 21-day sessions of treatment. At the same time, carboplatin (Qilu Pharmaceutical Co., Ltd., Jinan, Shandong Province, China; National Drug Approval Number: H20020181) will be intravenously administered at AUC = 2 mg•min/mL for 120 minutes on days 1 and 8 of each 21-day session of treatment. Carboplatin must be hydrated for 3 days before use to prevent nephrotoxicity.

DRUG

Epirubicin combined with docetaxel

Epirubicin (Pfizer Pharmaceutical (Wuxi) Co., Ltd., China; National Drug Approval Number: H20000496) will be intravenously administered at 90 mg/m2 for 120 minutes on day 1 of each 21-day session of treatment. At the same time, docetaxel (Sanofi-aventis Deutschland GmbH, Frankfurt am Main, Germany; National Drug Approval Number: J20150083) will be intravenously administered at 75 mg/m2 for 120 minutes. Drug administration will be performed once every other 3 weeks for four times.

Locations (7)

Cancer Hospital Affiliated to Harbin Medical University

Harbin, Heilongjiang, China

The Second Hospital of Jilin University

Changchun, Jilin, China

Dalian Municipal Central Hospital

Dalian, Liaoning, China

Panjin Liaohe Oilfield Gem Flower Hospital

Panjin, Liaoning, China

Shengjing Hospital of China Medical University

Shenyang, Liaoning, China

The Fourth Affiliated Hospital of China Medical University

Shenyang, Liaoning, China

Liaoning Cancer Hospital & Institute

Shenyang, Liaoning, China