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NCT Number: NCT04159142

Nab-paclitaxel Plus Carboplatin Versus Nab-paclitaxel Plus Capecitabine in the Treatment of Advanced Triple-negative Breast Cancer

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.

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 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.

Exclusion criteria

  • 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.

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 + Capecitabine

Drug

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;

Primary outcomes

  1. Progression free survival (PFS)

    Time frame: 3 years

    Up to disease progression or death due to any cause

Secondary outcomes

  1. PFS rate for 6 cycles

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

    From the date of randomization to the end of 6 cycles

  2. Objective response rate (ORR)

    Time frame: 3 years

    To evaluate the Overall Response Rate of patients with advanced triple-negative breast cancer

  3. Overall survival (OS)

    Time frame: 3 years

    To evaluate the overall survival of patients with advanced triple-negative breast cancer

  4. Adverse events (AE)

    Time frame: 3 years

    To evaluate the adverse events of patients with advanced triple-negative breast cancer

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 Capecitabine in the Treatment of Advanced Triple-negative Breast Cancer

Important dates

Study start
2019
Primary completion
2026
Study completion
2028
First posted
Nov 12, 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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