Docetaxel 2-weeks Regimen in the Treatment of HER2 Negative Metastatic Breast Cancer
- Registration Number
- NCT03147963
- Lead Sponsor
- Zhejiang Cancer Hospital
- 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
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 90
- 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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Docetaxel 3-Weeks regimen group Docetaxel Docetaxel injection 75mg/m2,iv,d1,every 3 weeks Docetaxel 2-Weeks regimen group Docetaxel Docetaxel injection 50mg/m2,iv,d1,every 2 weeks
- Primary Outcome Measures
Name Time Method Progression-free survival(PFS) 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
- Secondary Outcome Measures
Name Time Method Quality of life（QOL） 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.
Number of participants with Grade 3/4 adverse events 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.
Overall survival(OS) 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
Clinical benefit rate(CBR) 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
Trial Locations
- Locations (1)
Zhejiang Cancer Hospital
🇨🇳Hangzhou, Zhejiang, China