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Docetaxel 2-weeks Regimen in the Treatment of HER2 Negative Metastatic Breast Cancer

Primary Purpose

Breast Cancer

Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Docetaxel
Sponsored by
Zhejiang Cancer Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Breast Cancer focused on measuring therapy, breast cancer, docetaxel, metastasis

Eligibility Criteria

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

Inclusion Criteria:

  • Signed informed consent
  • The age is Above 18 years of age, <70 years old
  • The diagnosis of breast cancer was confirmed by cytological examination or pathological examination. HER2-negative
  • Clinical stage was metastatic breast cancer or locally advanced breast cancer.
  • Must have at least one measurable lesion, according to RECISTv1.1.
  • Eastern Cooperative Oncology Group performance status (ECOG PS)=0~2
  • Docetaxel or paclitaxel can been used in initial treatment or in the past for locally advanced, recurrent or metastatic lesions,if used must been proved effective, and recent progress over 6 months.
  • The basic function of normal bone marrow
  • Functions of liver and kidney is normal
  • Expectation of life is more than 3 months
  • Agreed to take contraceptive measures during treatment

Exclusion Criteria:

  • The patient had a history of allergy to taxanes or their components.
  • Recent progress of taxanes in 6 months.
  • In the elution period of other chemotherapy regimens.
  • Severe coagulopathy.
  • HER2 positive breast cancer
  • Previous toxicity was not recovered to 0-1 degrees
  • Central nervous system metastasis had not Controlled yet
  • Pregnancy or lactation
  • There are uncontrolled infection, myocardial infarction, thrombosis, etc.
  • There are uncontrolled chronic diseases such as diabetes, hypertension, peptic ulcer, chronic hepatitis, mental disease;
  • HIV infection
  • Patients with other malignant tumor history, except the healed skin basal cell carcinoma and carcinoma of uterine cervix;
  • Researchers believe that is not suitable for the study

Sites / Locations

  • Zhejiang Cancer HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Docetaxel 2-Weeks regimen group

Docetaxel 3-Weeks regimen group

Arm Description

Docetaxel injection 50mg/m2,iv,d1,every 2 weeks

Docetaxel injection 75mg/m2,iv,d1,every 3 weeks

Outcomes

Primary Outcome Measures

Progression-free survival(PFS)
Progression-free survival (PFS) is defined as the time elapsed between enrolling and tumor progression or death from any cause

Secondary Outcome Measures

Overall survival(OS)
The time elapsed between enrolling and death from any cause
Clinical benefit rate(CBR)
The response is CR+PR+SD ≥ 24 weeks
Quality of life（QOL）
Score change from enrolling to progression disease or death according EORTC QLQ-C30.The EORTC QLQ-C30 is a questionnaire developed to assess the quality of life of cancer patients.
Number of participants with Grade 3/4 adverse events
Number of participants with Grade 3/4 adverse events of the two groups was assessed in accordance with the common terminology criteria (NCI CTC AE) version 4.0.

Full Information

First Posted
May 4, 2017
Last Updated
May 7, 2017
Sponsor
Zhejiang Cancer Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03147963
Brief Title
Docetaxel 2-weeks Regimen in the Treatment of HER2 Negative Metastatic Breast Cancer
Official Title
A Randomized, Controlled Clinical Trial Comparing the Efficacy and Safety of a Single Agent Docetaxel 2-weeks Regimen in the Treatment of HER2 Negative Metastatic Breast Cancer to a 3-weeks Regimen
Study Type
Interventional

2. Study Status

Record Verification Date
May 2017
Overall Recruitment Status
Unknown status
Study Start Date
December 20, 2015 (Actual)
Primary Completion Date
December 30, 2019 (Anticipated)
Study Completion Date
December 30, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Zhejiang Cancer Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
A Randomized, Controlled Clinical Trial Comparing the Efficacy and Safety of a Single Agent Docetaxel 2-Weeks Regimen in the Treatment of HER2 Negative Metastatic Breast Cancer to a 3-Weeks Regimen
Detailed Description
Docetaxel 2-Weeks Regimen:Docetaxel 50mg/m2 Docetaxel 3-Weeks Regimen:Docetaxel 75mg/m2

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
therapy, breast cancer, docetaxel, metastasis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
patients was divided 1:1 into docetaxel 2-weeks regimen group and docetaxel 3-weeks regimen group
Masking
None (Open Label)
Allocation
Randomized
Enrollment
90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Docetaxel 2-Weeks regimen group
Arm Type
Experimental
Arm Description
Docetaxel injection 50mg/m2,iv,d1,every 2 weeks
Arm Title
Docetaxel 3-Weeks regimen group
Arm Type
Active Comparator
Arm Description
Docetaxel injection 75mg/m2,iv,d1,every 3 weeks
Intervention Type
Drug
Intervention Name(s)
Docetaxel
Intervention Description
Docetaxel will be given until progression or patient intolerance
Primary Outcome Measure Information:
Title
Progression-free survival(PFS)
Description
Progression-free survival (PFS) is defined as the time elapsed between enrolling and tumor progression or death from any cause
Time Frame
From date of enrolling until the date of first documented progression or date of death from any cause, whichever came first,assessed up to 5 years
Secondary Outcome Measure Information:
Title
Overall survival(OS)
Description
The time elapsed between enrolling and death from any cause
Time Frame
From date of enrolling until the date of death from any cause, assessed up to 5 years
Title
Clinical benefit rate(CBR)
Description
The response is CR+PR+SD ≥ 24 weeks
Time Frame
From date of enrolling until the date of first documented progression or date of death from any cause, whichever came first,assessed up to 5 years
Title
Quality of life（QOL）
Description
Score change from enrolling to progression disease or death according EORTC QLQ-C30.The EORTC QLQ-C30 is a questionnaire developed to assess the quality of life of cancer patients.
Time Frame
From date of enrolling until the date of first documented progression or date of death from any cause, whichever came first，assessed up to 5 years
Title
Number of participants with Grade 3/4 adverse events
Description
Number of participants with Grade 3/4 adverse events of the two groups was assessed in accordance with the common terminology criteria (NCI CTC AE) version 4.0.
Time Frame
From date of enrolling until the date of 1 month of stop treatment, assessed up to 5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Signed informed consent The age is Above 18 years of age, <70 years old The diagnosis of breast cancer was confirmed by cytological examination or pathological examination. HER2-negative Clinical stage was metastatic breast cancer or locally advanced breast cancer. Must have at least one measurable lesion, according to RECISTv1.1. Eastern Cooperative Oncology Group performance status (ECOG PS)=0~2 Docetaxel or paclitaxel can been used in initial treatment or in the past for locally advanced, recurrent or metastatic lesions,if used must been proved effective, and recent progress over 6 months. The basic function of normal bone marrow Functions of liver and kidney is normal Expectation of life is more than 3 months Agreed to take contraceptive measures during treatment Exclusion Criteria: The patient had a history of allergy to taxanes or their components. Recent progress of taxanes in 6 months. In the elution period of other chemotherapy regimens. Severe coagulopathy. HER2 positive breast cancer Previous toxicity was not recovered to 0-1 degrees Central nervous system metastasis had not Controlled yet Pregnancy or lactation There are uncontrolled infection, myocardial infarction, thrombosis, etc. There are uncontrolled chronic diseases such as diabetes, hypertension, peptic ulcer, chronic hepatitis, mental disease; HIV infection Patients with other malignant tumor history, except the healed skin basal cell carcinoma and carcinoma of uterine cervix; Researchers believe that is not suitable for the study
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xiaojia WANG, MD,PHD
Phone
8613906500190
Email
wxiaojia0803@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Ping HUANG, MD
Phone
8613685766632
Email
zlyyhp@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xiaojia WANG, MD,PHD
Organizational Affiliation
Zhejiang Cance Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Zhejiang Cancer Hospital
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310022
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiaojia WANG, MD,PhD
Phone
+86 13906500190
Email
wxiaojia0803@163.com
First Name & Middle Initial & Last Name & Degree
Ping HUANG, MD
Phone
+86 13685766632
Email
zlyyhp@163.com
First Name & Middle Initial & Last Name & Degree
Xiaojia WANG, MD,PhD

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
12637459
Citation
Nabholtz JM, Falkson C, Campos D, Szanto J, Martin M, Chan S, Pienkowski T, Zaluski J, Pinter T, Krzakowski M, Vorobiof D, Leonard R, Kennedy I, Azli N, Murawsky M, Riva A, Pouillart P; TAX 306 Study Group. Docetaxel and doxorubicin compared with doxorubicin and cyclophosphamide as first-line chemotherapy for metastatic breast cancer: results of a randomized, multicenter, phase III trial. J Clin Oncol. 2003 Mar 15;21(6):968-75. doi: 10.1200/JCO.2003.04.040. Erratum In: J Clin Oncol. 2003 May 15;21(10):2048.
Results Reference
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Docetaxel 2-weeks Regimen in the Treatment of HER2 Negative Metastatic Breast Cancer

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