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

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexFemale
Age18-70
SponsorHebei Medical University Fourth Hospital

About this trial

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 criteria

Qualifiers

Females with age between 18 to 70 years old;

Histologically confirmed primary invasive breast cancer;

Histologically confirmed triple negative breast cancer;

Patients who planned to accept preoperative neoadjuvant therapy and had a mass larger than 2 cm.

Disqualifiers

Previous treatment with any cytotoxic chemotherapy, endocrine therapy, biotherapy or radiotherapy;

Patients with heart disease above grade II (including grade II) identified by New York Heart Association (NYHA) scores;

Patients with severe systemic infection or other serious diseases;

Patients allergic to or intolerant of chemotherapeutic drugs or their adjuvants;

Trial design

Treatments tested in this trial

  • Nab-paclitaxel + Carboplatin
  • Nab-paclitaxel + Epirubicin

Treatment groups

520 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Hebei Medical University Fourth Hospital

Lead sponsor

Beijing 302 Hospital

Collaborator

CSPC Ouyi Pharmaceutical Co., Ltd.

Collaborator