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Nab-paclitaxel Plus Carboplatin Versus Nab-paclitaxel Plus Capecitabine in the Treatment of Advanced Triple-negative Breast Cancer

NCT04159142 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 414

Last updated 2025-09-11

No results posted yet for this study

Summary

This is a multi-center , open-lable clinical trial. 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. TNBC is diagnosed in 15-20% of breast cancer cases and tends to occur in younger women and have biologically more aggressive high grade disease.

The purpose of this study is to assess the efficacy and safety of the following two combinations: i) nab-paclitaxel+carboplatin; ii) nab-paclitaxel+capecitabine in subjects with advanced TNBC and up to one prior line of systemic treatment for metastatic disease. Maintenance therapy with capecitabine after completion of combination chemotherapy.

Conditions

Interventions

DRUG

Nab-paclitaxel + Carboplatin

nab-paclitaxel given IV at 125 mg/m\^2 on days 1, 8 and carboplatin given IV at AUC 5 on days 1 every 21 days x 6 cycles；

DRUG

Nab-paclitaxel + Capecitabine

Nab-paclitaxel given IV at 125 mg/m\^2 on days 1, 8 and capecitabine given IV at 1000 mg/m\^2 bid, d1-14 every 21 days x 6 cycles；

Sponsors & Collaborators

  • Beijing 302 Hospital

    collaborator OTHER

  • CSPC Ouyi Pharmaceutical Co., Ltd.

    collaborator INDUSTRY

  • Hebei Medical University Fourth Hospital

    lead OTHER

Principal Investigators

  • Zefei Jiang, M.D. · Beijing 302 Hospital

  • Cuizhi Geng, M.D. · Hebei Medical University Fourth Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-11-20
Primary Completion
2026-06-20
Completion
2028-09-20

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04159142 on ClinicalTrials.gov