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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
Docetaxel 2-Weeks Regimen:Docetaxel 50mg/m2 Docetaxel 3-Weeks Regimen:Docetaxel 75mg/m2
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Docetaxel 2-Weeks regimen group | Experimental | Docetaxel injection 50mg/m2,iv,d1,every 2 weeks |
|
| Docetaxel 3-Weeks regimen group | Active Comparator | Docetaxel injection 75mg/m2,iv,d1,every 3 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Docetaxel | Drug | Docetaxel will be given until progression or patient intolerance |
|
| 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 |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xiaojia WANG, MD,PHD | Contact | 8613906500190 | wxiaojia0803@163.com | |
| Ping HUANG, MD | Contact | 8613685766632 | zlyyhp@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Xiaojia WANG, MD,PHD | Zhejiang Cance Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zhejiang Cancer Hospital | Recruiting | Hangzhou | Zhejiang | 310022 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 12637459 | Background | 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. |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D009362 | Neoplasm Metastasis |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| D000077143 | Docetaxel |
| ID | Term |
|---|---|
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
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patients was divided 1:1 into docetaxel 2-weeks regimen group and docetaxel 3-weeks regimen group
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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 |
| D017437 |
| Skin and Connective Tissue Diseases |
| D009385 | Neoplastic Processes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006844 |
| Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |