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

Clinical Study of 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.

Study Overview

• Status: Recruiting
• Conditions: Breast Cancer; Triple-negative Breast Cancer; Nab-paclitaxel
• Intervention / Treatment: Drug: Nab-paclitaxel + Carboplatin; Drug: Nab-paclitaxel + Epirubicin

• Study Type: Interventional
• Enrollment (Estimated): 520
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Cuizhi Geng, M.D.; Phone Number: 0311-6669 6310; Email: gengcuizhi@hotmail.com

Study Locations

• China
  • Hebei
    • Shijiazhuang, Hebei, China, 050011
      • Recruiting
      • The Fourth Hospital of Hebei Medical University
      • Contact: Cuizhi Geng, M.D.; Phone Number: 0311-6669 6310; Email: gengcuizhi@hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Females with age between 18 to 70 years old;
2. Histologically confirmed primary invasive breast cancer;
3. Histologically confirmed triple negative breast cancer;
4. Patients who planned to accept preoperative neoadjuvant therapy and had a mass larger than 2 cm.
5. Blood specimens and 5 sections of tumor tissue at baseline, blood specimens at surgery can be obtained.
6. Have at least one measurable lesion as per the RECIST criteria (version 1.1);
7. Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to one;
8. LVEF≥55%；
9. Bone marrow function：neutrophils (≥1.5×10^9/L), platelets (≥100×10^9/L), hemoglobin (≥90 g/L);
10. 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;
11. Patients had good compliance with the planned treatment, understood the research process and written informed consent.

Exclusion Criteria:

1. Previous treatment with any cytotoxic chemotherapy, endocrine therapy, biotherapy or radiotherapy;
2. Patients with heart disease above grade II (including grade II) identified by New York Heart Association (NYHA) scores;
3. Patients with severe systemic infection or other serious diseases;
4. Patients allergic to or intolerant of chemotherapeutic drugs or their adjuvants;
5. Patients with other malignant tumors in the past five years, except for cured cervical carcinoma in situ and non-melanoma skin cancer;
6. Pregnancy or lactation, as well as reproductive age patients who refused to take appropriate contraceptive measures in the trial;
7. Participation in any trial drug treatment or another interventional clinical trial 30 days before first dose was given;
8. The researchers considered the patients who were not suitable for enrollment.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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 + 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;
Active Comparator: Nab-paclitaxel + Epirubicin; 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；	Drug: Nab-paclitaxel + Epirubicin; 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；

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
pCR (pathological complete response)	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	3 years

Secondary Outcome Measures

Outcome Measure	Time Frame
Objective response rate (ORR)	3 years
Disease free survival（DFS）	3 years
Adverse events (AE)	3 years

Collaborators and Investigators

• Sponsor: Hebei Medical University Fourth Hospital
• Collaborators: Beijing 302 Hospital; CSPC Ouyi Pharmaceutical Co., Ltd.
• Investigators: Study Chair: Zefei Jiang, M.D., Beijing 302 Hospital; Study Chair: Cuizhi Geng, M.D., Hebei Medical University Fourth Hospital

Study record dates

Study Major Dates

• Study Start (Actual): November 20, 2019
• Primary Completion (Estimated): October 20, 2026
• Study Completion (Estimated): June 20, 2028

Study Registration Dates

• First Submitted: October 23, 2019
• First Submitted That Met QC Criteria: October 23, 2019
• First Posted (Actual): October 24, 2019

Study Record Updates

• Last Update Posted (Estimated): September 11, 2025
• Last Update Submitted That Met QC Criteria: September 10, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Keywords: Triple-negative Breast Cancer; Epirubicin; Carboplatin; Nab-paclitaxel
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Skin Diseases; Breast Diseases; Skin and Connective Tissue Diseases; Breast Neoplasms; Triple Negative Breast Neoplasms; Organic Chemicals; Hydrocarbons; Hydrocarbons, Cyclic; Carbohydrates; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Polycyclic Compounds; Glycosides; Coordination Complexes; Anthracyclines; Naphthacenes; Aminoglycosides; Daunorubicin; Doxorubicin; Carboplatin; Epirubicin; 130-nm albumin-bound paclitaxel
• Other Study ID Numbers: CSPC-KAL-BC-11

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No