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

PHASE4RecruitingINTERVENTIONAL
Enrollment

110

Participants

Timeline

Start Date

July 19, 2021

Primary Completion Date

November 30, 2025

Study Completion Date

November 30, 2026

Conditions
Breast Cancer
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.

Trial Locations (7)

110004

RECRUITING

Shengjing Hospital of China Medical University, Shenyang

110032

RECRUITING

The Fourth Affiliated Hospital of China Medical University, Shenyang

110042

RECRUITING

Liaoning Cancer Hospital & Institute, Shenyang

116033

RECRUITING

Dalian Municipal Central Hospital, Dalian

124010

RECRUITING

Panjin Liaohe Oilfield Gem Flower Hospital, Panjin

130041

RECRUITING

The Second Hospital of Jilin University, Changchun

150081

RECRUITING

Cancer Hospital Affiliated to Harbin Medical University, Harbin

All Listed Sponsors
lead

Shengjing Hospital

OTHER

NCT04136782 - Albumin-bound Paclitaxel and Carboplatin Versus Epirubicin and Docetaxel for Triple-negative Breast Cancer | Biotech Hunter | Biotech Hunter