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

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.

Study Overview

• Status: Unknown
• Conditions: Breast Cancer
• Intervention / Treatment: Drug: nab-paclitaxel followed by anthracycline and cyclophosphamide; Drug: Docetaxel followed by anthracycline and cyclophosphamide

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Phase 4

Contacts and Locations

Study Locations

• China
  • Shaanxi
    • Xi'an, Shaanxi, China, 710032
      • Recruiting
      • Xijing Hospital
      • Contact: Juliang Zhang, Prof; Phone Number: 029-8477527; Email: vascularzhang@163.com

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• 1) age: 18-70 years old, female;

  2) patients with primary breast cancer, T2 or above, diagnosed by histopathology;

  3) HR was positive and HER-2 was negative by IHC;

  4) according to the RECIST 1.1 standard, there should be at least one measurable objective focus with tumor diameter > 2cm;

  5) ECoG physical fitness score 0-1;

  6) LVEF≥55%；

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

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

  9) patients have good compliance with the planned treatment, can understand the research process of this study and sign the written informed consent

Exclusion Criteria:

• 1) previously received cytotoxic chemotherapy, endocrine therapy, biological therapy or radiotherapy for any reason;

  2) patients with stage IV metastasis at the initial diagnosis;

  2) New York Heart Association (NYHA) rating of patients with heart disease above grade II (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 their adjuvants;

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

  6) pregnancy or lactation, as well as childbearing age patients who refuse to take appropriate contraceptive measures during the trial;

  7) participated in other experimental studies within 30 days before the administration of the first study drug;

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

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
Active Comparator: Docetaxel	Drug: Docetaxel followed by anthracycline and cyclophosphamide; Docetaxel 100 mg/m2 for for every 2 weeks followed by anthracycline and cyclophosphamide
Experimental: nab-paclitaxel	Drug: nab-paclitaxel followed by anthracycline and cyclophosphamide; nab-paclitaxel 260mg/m2 for every 2 weeks followed by anthracycline and cyclophosphamide

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
RCB	Residual tumor load	2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
pCR	Complete remission of Pathology	2 years

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
DFS	Disease free survival	2 years
OS	Overall survival time	2 years

Collaborators and Investigators

• Sponsor: Xijing Hospital

Study record dates

Study Major Dates

• Study Start (Actual): August 21, 2019
• Primary Completion (Anticipated): August 21, 2021
• Study Completion (Anticipated): August 21, 2022

Study Registration Dates

• First Submitted: November 27, 2019
• First Submitted That Met QC Criteria: November 27, 2019
• First Posted (Actual): December 2, 2019

Study Record Updates

• Last Update Posted (Actual): December 2, 2019
• Last Update Submitted That Met QC Criteria: November 27, 2019
• Last Verified: November 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Antirheumatic Agents; Antineoplastic Agents; Immunosuppressive Agents; Immunologic Factors; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Antineoplastic Agents, Alkylating; Alkylating Agents; Myeloablative Agonists; Antineoplastic Agents, Phytogenic; Docetaxel; Cyclophosphamide; Paclitaxel
• Other Study ID Numbers: KY20192081-F-1

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No