NCT04138719

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
520

participants targeted

Target at P75+ for phase_2 breast-cancer

Timeline
26mo left

Started Nov 2019

Longer than P75 for phase_2 breast-cancer

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress75%
Nov 2019Jun 2028

First Submitted

Initial submission to the registry

October 23, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 24, 2019

Completed
27 days until next milestone

Study Start

First participant enrolled

November 20, 2019

Completed
6.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 20, 2026

Expected
1.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 20, 2028

Last Updated

September 11, 2025

Status Verified

September 1, 2025

Enrollment Period

6.9 years

First QC Date

October 23, 2019

Last Update Submit

September 10, 2025

Conditions

Breast CancerTriple-negative Breast CancerNab-paclitaxel

Keywords

Triple-negative Breast CancerNab-paclitaxelCarboplatinEpirubicin

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Objective response rate (ORR)

    3 years

  • Disease free survival（DFS）

    3 years

  • Adverse events (AE)

    3 years

Study Arms (2)

Nab-paclitaxel + Carboplatin

EXPERIMENTAL

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 + Epirubicin

ACTIVE COMPARATOR

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

Interventions

Nab-paclitaxel + CarboplatinDRUG

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 + Carboplatin
Nab-paclitaxel + EpirubicinDRUG

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；

Nab-paclitaxel + Epirubicin

Eligibility Criteria

Age18 Years - 70 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsFemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Fourth Hospital of Hebei Medical University

Shijiazhuang, Hebei, 050011, China

RECRUITING

MeSH Terms

Conditions

Breast NeoplasmsTriple Negative Breast Neoplasms

Interventions

130-nm albumin-bound paclitaxelCarboplatinEpirubicin

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Coordination ComplexesOrganic ChemicalsDoxorubicinDaunorubicinAnthracyclinesNaphthacenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsPolycyclic CompoundsAminoglycosidesGlycosidesCarbohydrates

Study Officials

  • Zefei Jiang, M.D.

    Beijing 302 Hospital

    STUDY CHAIR

  • Cuizhi Geng, M.D.

    Hebei Medical University Fourth Hospital

    STUDY CHAIR

Central Study Contacts

Cuizhi Geng, M.D.

CONTACT

0311-6669 6310gengcuizhi@hotmail.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
M.D.

Study Record Dates

First Submitted

October 23, 2019

First Posted

October 24, 2019

Study Start

November 20, 2019

Primary Completion (Estimated)

October 20, 2026

Study Completion (Estimated)

June 20, 2028

Last Updated

September 11, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)