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

Primary Purpose

Breast Cancer

Status
Unknown status
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
nab-paclitaxel followed by anthracycline and cyclophosphamide
Docetaxel followed by anthracycline and cyclophosphamide
Sponsored by
Xijing Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Breast Cancer

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Xijing hospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

nab-paclitaxel

Docetaxel

Arm Description

Outcomes

Primary Outcome Measures

RCB
Residual tumor load

Secondary Outcome Measures

pCR
Complete remission of Pathology

Full Information

First Posted
November 27, 2019
Last Updated
November 27, 2019
Sponsor
Xijing Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04182568
Brief Title
Nab-paclitaxel Compared With Docetaxel Followed by Anthracyclines and Cyclophosphamide in the Neoadjuvant Breast Cancer
Official Title
Nab-paclitaxel Compared With Docetaxel Followed by Anthracyclines and Cyclophosphamide in the Neoadjuvant Breast Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
November 2019
Overall Recruitment Status
Unknown status
Study Start Date
August 21, 2019 (Actual)
Primary Completion Date
August 21, 2021 (Anticipated)
Study Completion Date
August 21, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Xijing Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
nab-paclitaxel
Arm Type
Experimental
Arm Title
Docetaxel
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
nab-paclitaxel followed by anthracycline and cyclophosphamide
Intervention Description
nab-paclitaxel 260mg/m2 for every 2 weeks followed by anthracycline and cyclophosphamide
Intervention Type
Drug
Intervention Name(s)
Docetaxel followed by anthracycline and cyclophosphamide
Intervention Description
Docetaxel 100 mg/m2 for for every 2 weeks followed by anthracycline and cyclophosphamide
Primary Outcome Measure Information:
Title
RCB
Description
Residual tumor load
Time Frame
2 years
Secondary Outcome Measure Information:
Title
pCR
Description
Complete remission of Pathology
Time Frame
2 years
Other Pre-specified Outcome Measures:
Title
DFS
Description
Disease free survival
Time Frame
2 years
Title
OS
Description
Overall survival time
Time Frame
2 years

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Juliang Zhang, Prof
Phone
029-84775271
Email
vascularzhang@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Meiling Huang, MD
Phone
029-8477527
Email
huangmeiling@126.com
Facility Information:
Facility Name
Xijing hospital
City
Xi'an
State/Province
Shaanxi
ZIP/Postal Code
710032
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Juliang Zhang, Prof
Phone
029-8477527
Email
vascularzhang@163.com

12. IPD Sharing Statement

Learn more about this trial

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

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