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

Study Overview
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Brief Summary
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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
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Docetaxel 2-Weeks Regimen:Docetaxel 50mg/m2 Docetaxel 3-Weeks Regimen:Docetaxel 75mg/m2

Official Title
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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

Conditions
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Breast Cancer

Intervention / Treatment
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* Drug: Docetaxel


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Docetaxel 2-Weeks regimen group<br>Docetaxel injection 50mg/m2,iv,d1,every 2 weeks | Drug: Docetaxel<br>* Docetaxel will be given until progression or patient intolerance<br>|
| Active Comparator: Docetaxel 3-Weeks regimen group<br>Docetaxel injection 75mg/m2,iv,d1,every 3 weeks | Drug: Docetaxel<br>* Docetaxel will be given until progression or patient intolerance<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression-free survival(PFS) | 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) | 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) | 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） | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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metastasis, therapy, breast cancer, docetaxel