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NCT Number: NCT04138719

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

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.

Recruiting

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Key information

Age range

18 year–70 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

The Fourth Hospital of Hebei Medical University

Shijiazhuang, Hebei, 050011, China

Location status: Recruiting

Location contact

Cuizhi Geng, M.D.

CONTACT

[email protected]

0311-6669 6310

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.
  • Blood specimens and 5 sections of tumor tissue at baseline, blood specimens at surgery can be obtained.
  • Have at least one measurable lesion as per the RECIST criteria (version 1.1);
  • Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to one;
  • LVEF≥55%;
  • Bone marrow function:neutrophils (≥1.5×10^9/L), platelets (≥100×10^9/L), hemoglobin (≥90 g/L);
  • Renal and hepatic function: Serum creatinine≤ 1.5×institutional upper limit of normal (ULN); AST and ALT ≤ 2.5 × ULN; Total bilirubin≤1.5×ULN, or patients with Gilbert's syndrome ≤ 2.5 × ULN;
  • Patients had good compliance with the planned treatment, understood the research process and written informed consent.

Exclusion criteria

  • 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;
  • Patients with other malignant tumors in the past five years, except for cured cervical carcinoma in situ and non-melanoma skin cancer;
  • Pregnancy or lactation, as well as reproductive age patients who refused to take appropriate contraceptive measures in the trial;
  • Participation in any trial drug treatment or another interventional clinical trial 30 days before first dose was given;
  • The researchers considered the patients who were not suitable for enrollment.

Treatment and study plan

Nab-paclitaxel + Carboplatin

Drug

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;

Nab-paclitaxel + Epirubicin

Drug

nab-paclitaxel given IV at 125 mg/m^2 on days 1, 8 and epirubicin given IV at 75 mg/m^2 on days 1 every 21 days x 6 cycles;

Primary outcomes

  1. pCR (pathological complete response)

    Time frame: 3 years

    No residual infiltrating cancer cells were found in surgical specimens of breast and axillary lymph nodes; residual cancer cells in situ in surgical specimens can also be considered to achieve pCR

Secondary outcomes

  1. Objective response rate (ORR)

    Time frame: 3 years

  2. Disease free survival(DFS)

    Time frame: 3 years

  3. Adverse events (AE)

    Time frame: 3 years

Study contacts

Contact information is provided by the study sponsor or research team.

Cuizhi Geng, M.D.

CONTACT

[email protected]

0311-6669 6310

Sponsors and collaborators

Lead sponsor

Hebei Medical University Fourth Hospital

Other

Collaborators

  • Beijing 302 Hospital
  • CSPC Ouyi Pharmaceutical Co., Ltd.

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2026
Study completion
2028
First posted
Oct 24, 2019
Registry last updated
Sep 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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