Actively Recruiting

Phase 2
Age: 18Years - 70Years
FEMALE
NCT04138719

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

Led by Hebei Medical University Fourth Hospital · Updated on 2025-09-11

520

Participants Needed

1

Research Sites

447 weeks

Total Duration

On this page

Sponsors

H

Hebei Medical University Fourth Hospital

Lead Sponsor

B

Beijing 302 Hospital

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 70Years
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Female aged between 18 to 70 years old
  • Histologically confirmed primary invasive breast cancer
  • Histologically confirmed triple-negative breast cancer
  • Planned to receive preoperative neoadjuvant therapy with a tumor larger than 2 cm
  • Ability to provide blood specimens and tumor tissue samples at baseline and surgery
  • At least one measurable lesion based on RECIST criteria (version 1.1)
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • Left ventricular ejection fraction (LVEF) of 55% or higher
  • Adequate bone marrow function: neutrophils ≥1.5 × 10^9/L, platelets ≥100 × 10^9/L, hemoglobin ≥90 g/L
  • Adequate renal and liver function: serum creatinine ≤1.5 times institutional upper limit, AST and ALT ≤2.5 times upper limit, total bilirubin ≤1.5 times upper limit (or ≤2.5 times for Gilbert's syndrome)
  • Good compliance with treatment plan and informed consent provided
Not Eligible

You will not qualify if you...

  • Previous treatment with any chemotherapy, endocrine therapy, biotherapy, or radiotherapy
  • Heart disease classified as New York Heart Association (NYHA) grade II or higher
  • Severe systemic infection or other serious diseases
  • Allergy or intolerance to chemotherapeutic drugs or their components
  • Other cancers within the past five years except cured cervical carcinoma in situ or non-melanoma skin cancer
  • Pregnancy or breastfeeding, or refusal to use contraception during the trial
  • Participation in another clinical trial involving drug treatment within 30 days before starting this study
  • Considered unsuitable for enrollment by the researchers

AI-Screening

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Trial Site Locations

Total: 1 location

1

The Fourth Hospital of Hebei Medical University

Shijiazhuang, Hebei, China, 050011

Actively Recruiting

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Research Team

C

Cuizhi Geng, M.D.

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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