NCT04159142

Brief Summary

This is a multi-center , open-lable clinical trial. 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. TNBC is diagnosed in 15-20% of breast cancer cases and tends to occur in younger women and have biologically more aggressive high grade disease. The purpose of this study is to assess the efficacy and safety of the following two combinations: i) nab-paclitaxel+carboplatin; ii) nab-paclitaxel+capecitabine in subjects with advanced TNBC and up to one prior line of systemic treatment for metastatic disease. Maintenance therapy with capecitabine after completion of combination chemotherapy.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
414

participants targeted

Target at P75+ for phase_2

Timeline
28mo left

Started Nov 2019

Longer than P75 for phase_2

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 Progress74%
Nov 2019Sep 2028

First Submitted

Initial submission to the registry

October 23, 2019

Completed
20 days until next milestone

First Posted

Study publicly available on registry

November 12, 2019

Completed
8 days until next milestone

Study Start

First participant enrolled

November 20, 2019

Completed
6.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 20, 2026

Expected
2.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 20, 2028

Last Updated

September 11, 2025

Status Verified

September 1, 2025

Enrollment Period

6.6 years

First QC Date

October 23, 2019

Last Update Submit

September 10, 2025

Conditions

Triple Negative Breast CancerNab-paclitaxel

Keywords

Nab-paclitaxelCarboplatinCapecitabineTriple Negative Breast CancerMaintenance therapy

Outcome Measures

Primary Outcomes (1)

  • Progression free survival (PFS)

    Up to disease progression or death due to any cause

    3 years

Secondary Outcomes (4)

  • PFS rate for 6 cycles

    At the end of Cycle 6 (each cycle is 21 days)

  • Objective response rate (ORR)

    3 years

  • Overall survival (OS)

    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； Maintenance therapy: Capecitabine 1000 mg/m\^2 bid, d1-14; every 21 days, until disease progression or intolerable toxicity;

Drug: Nab-paclitaxel + Carboplatin

Nab-paclitaxel + Capecitabine

EXPERIMENTAL

Nab-paclitaxel given IV at 125 mg/m\^2 on days 1, 8 and capecitabine given IV at 1000 mg/m\^2 bid, d1-14 every 21 days x 6 cycles； Maintenance therapy: Capecitabine 1000 mg/m\^2 bid, d1-14; every 21 days, until disease progression or intolerable toxicity;

Drug: Nab-paclitaxel + Capecitabine

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 + CapecitabineDRUG

Nab-paclitaxel given IV at 125 mg/m\^2 on days 1, 8 and capecitabine given IV at 1000 mg/m\^2 bid, d1-14 every 21 days x 6 cycles；

Nab-paclitaxel + Capecitabine

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 triple negative breast cancer;
  • No more than one-line prior treatment for locally advanced or metastatic breast cancer;
  • 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;
  • Patients with life expectancy of at least 3 months;
  • 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:

  • Patients with heart disease above grade II (including grade II) identified by New York Heart Association (NYHA) scores;
  • Brain metastasis;
  • Recurrence or metastasis within 6 months after capecitabine withdrawal;
  • Recurrence or metastasis within 6 months after platinum withdrawal;
  • Progression in the treatment, recurrence or metastasis of paclitaxel (including albumin paclitaxel) within 6 months;
  • Patients required clinical intervention with gastrointestinal bleeding, gastrointestinal obstruction and non-feeding;
  • Patients who had Grade 2 or above Peripheral neuropathy;
  • 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

Triple Negative Breast Neoplasms

Interventions

130-nm albumin-bound paclitaxelCarboplatinCapecitabine

Condition Hierarchy (Ancestors)

Breast NeoplasmsNeoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Coordination ComplexesOrganic ChemicalsDeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsFluorouracilUracilPyrimidinonesDeoxyribonucleosidesNucleosidesNucleic Acids, Nucleotides, and Nucleosides

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
Principal Investigator

Study Record Dates

First Submitted

October 23, 2019

First Posted

November 12, 2019

Study Start

November 20, 2019

Primary Completion (Estimated)

June 20, 2026

Study Completion (Estimated)

September 20, 2028

Last Updated

September 11, 2025

Record last verified: 2025-09

Locations

CN(1)