Clinical trial NCT03147963: 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
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Breast Cancer
Keywords: therapy
breast cancer
docetaxel
metastasis
Lead sponsor: Zhejiang Cancer Hospital
Sponsor class: OTHER
First posted: 2017-05-10
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: patients was divided 1:1 into docetaxel 2-weeks regimen group and docetaxel 3-weeks regimen group
Primary purpose: TREATMENT

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

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

Primary outcomes:
measure: Progression-free survival(PFS)
timeFrame: 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 outcomes:
measure: Overall survival(OS)
timeFrame: From date of enrolling until the date of death from any cause, assessed up to 5 years
measure: Clinical benefit rate(CBR)
timeFrame: 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: Quality of life（QOL）
timeFrame: 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: Number of participants with Grade 3/4 adverse events
timeFrame: From date of enrolling until the date of 1 month of stop treatment, assessed up to 5 years
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: Zhejiang Cancer Hospital
state: Zhejiang
Study officials:
affiliation: Zhejiang Cance Hospital
name: Xiaojia WANG, MD,PHD
role: PRINCIPAL_INVESTIGATOR
References:
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.