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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-12-20

Study Completion Date

2019-12-30

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

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Detailed Description

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Docetaxel 2-Weeks Regimen:Docetaxel 50mg/m2 Docetaxel 3-Weeks Regimen:Docetaxel 75mg/m2

Conditions

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Breast Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

patients was divided 1:1 into docetaxel 2-weeks regimen group and docetaxel 3-weeks regimen group

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Docetaxel 2-Weeks regimen group

Docetaxel injection 50mg/m2,iv,d1,every 2 weeks

Group Type EXPERIMENTAL

Docetaxel

Intervention Type DRUG

Docetaxel will be given until progression or patient intolerance

Docetaxel 3-Weeks regimen group

Docetaxel injection 75mg/m2,iv,d1,every 3 weeks

Group Type ACTIVE_COMPARATOR

Docetaxel

Intervention Type DRUG

Docetaxel will be given until progression or patient intolerance

Interventions

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Docetaxel

Docetaxel will be given until progression or patient intolerance

Intervention Type DRUG

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No