Nab-paclitaxel Compared With Docetaxel Followed by Anthracyclines and Cyclophosphamide in the Neoadjuvant Breast Cancer

Last updated: November 27, 2019
Sponsor: Xijing Hospital
Overall Status: Active - Recruiting

Phase

4

Condition

Breast Cancer

Cancer

Treatment

N/A

Clinical Study ID

NCT04182568
KY20192081-F-1
  • Ages 18-70
  • Female

Study Summary

This study is an open, multicenter, randomized controlled clinical trial for patients with newly diagnosed primary invasive breast cancer and clinical stage of T2 or above. The main purpose of this study is to evaluate the efficacy of dose-dense nab-paclitaxel compared with dose-dense docetaxel followed by anthracycline and cyclophosphamide in the treatment of HR positive and HER-2 negative breast cancer. The effectiveness and safety of the treatment.

Eligibility Criteria

Inclusion

Inclusion Criteria:

    1. age: 18-70 years old, female;
  1. patients with primary breast cancer, T2 or above, diagnosed by histopathology;

  2. HR was positive and HER-2 was negative by IHC;

  3. according to the RECIST 1.1 standard, there should be at least one measurableobjective focus with tumor diameter > 2cm;

  4. ECoG physical fitness score 0-1;

  5. LVEF≥55%;

  6. bone marrow function: neutrophil ≥ 1.5 × 109 / L, platelet ≥ 100 × 109 / L,hemoglobin ≥ 90g / L;

  7. liver and kidney function: serum creatinine ≤ 1.5 times the upper limit of normalvalue; AST and alt ≤ 2.5 times the upper limit of normal value; total bilirubin ≤ 1.5times the upper limit of normal value, or patients with Gilbert's syndrome ≤ 2.5 timesthe upper limit of normal value;

  8. patients have good compliance with the planned treatment, can understand theresearch process of this study and sign the written informed consent

Exclusion

Exclusion Criteria:

    1. previously received cytotoxic chemotherapy, endocrine therapy, biological therapyor radiotherapy for any reason;
  1. patients with stage IV metastasis at the initial diagnosis;

  2. New York Heart Association (NYHA) rating of patients with heart disease above gradeII (including grade II);

  3. patients with serious systemic infection or other serious diseases;

  4. patients who are known to be allergic or intolerant to chemotherapy drugs or theiradjuvants;

  5. in the past 5 years, there have been other malignant tumors, except the curedcarcinoma in situ of cervix and skin cancer without melanoma;

  6. pregnancy or lactation, as well as childbearing age patients who refuse to takeappropriate contraceptive measures during the trial;

  7. participated in other experimental studies within 30 days before the administrationof the first study drug;

  8. patients not suitable for the study were judged by the researchers.

Study Design

Total Participants: 100
Study Start date:
August 21, 2019
Estimated Completion Date:
August 21, 2022

Connect with a study center

  • Xijing hospital

    Xi'an, Shaanxi 710032
    China

    Active - Recruiting

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