- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03147963
Docetaxel 2-weeks Regimen in the Treatment of HER2 Negative Metastatic Breast Cancer
May 7, 2017 updated by: Huang Ping, Zhejiang Cancer Hospital
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
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 Overview
Detailed Description
Docetaxel 2-Weeks Regimen:Docetaxel 50mg/m2 Docetaxel 3-Weeks Regimen:Docetaxel 75mg/m2
Study Type
Interventional
Enrollment (Anticipated)
90
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Xiaojia WANG, MD,PHD
- Phone Number: 8613906500190
- Email: wxiaojia0803@163.com
Study Contact Backup
- Name: Ping HUANG, MD
- Phone Number: 8613685766632
- Email: zlyyhp@163.com
Study Locations
-
-
Zhejiang
-
Hangzhou, Zhejiang, China, 310022
- Recruiting
- Zhejiang Cancer Hospital
-
Contact:
- Ping HUANG, MD
- Phone Number: +86 13685766632
- Email: zlyyhp@163.com
-
Principal Investigator:
- Xiaojia WANG, MD,PhD
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Docetaxel 2-Weeks regimen group
Docetaxel injection 50mg/m2,iv,d1,every 2 weeks
|
Docetaxel will be given until progression or patient intolerance
|
Active Comparator: Docetaxel 3-Weeks regimen group
Docetaxel injection 75mg/m2,iv,d1,every 3 weeks
|
Docetaxel will be given until progression or patient intolerance
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Progression-free survival(PFS)
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
|
Progression-free survival (PFS) is defined as the time elapsed between enrolling and tumor progression or death from any cause
|
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 Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Overall survival(OS)
Time Frame: From date of enrolling until the date of death from any cause, assessed up to 5 years
|
The time elapsed between enrolling and death from any cause
|
From date of enrolling until the date of death from any cause, assessed up to 5 years
|
Clinical benefit rate(CBR)
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
|
The response is CR+PR+SD ≥ 24 weeks
|
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
|
Quality of life(QOL)
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
|
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.
|
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
|
Number of participants with Grade 3/4 adverse events
Time Frame: From date of enrolling until the date of 1 month of stop treatment, assessed up to 5 years
|
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.
|
From date of enrolling until the date of 1 month of stop treatment, assessed up to 5 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Xiaojia WANG, MD,PHD, Zhejiang Cance Hospital
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 20, 2015
Primary Completion (Anticipated)
December 30, 2019
Study Completion (Anticipated)
December 30, 2019
Study Registration Dates
First Submitted
May 4, 2017
First Submitted That Met QC Criteria
May 7, 2017
First Posted (Actual)
May 10, 2017
Study Record Updates
Last Update Posted (Actual)
May 10, 2017
Last Update Submitted That Met QC Criteria
May 7, 2017
Last Verified
May 1, 2017
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- ZCHBC0011
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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