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

University of Chinese Academy Sciences

Status and phase: Unknown; Phase 2

Conditions: Breast Cancer

Treatments: Drug: Docetaxel

Study type: Interventional

Funder types: Other

Identifiers

NCT03147963

ZCHBC0011

Details and patient eligibility

About

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

Full description

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

Enrollment: 90 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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90 participants in 2 patient groups

Docetaxel 2-Weeks regimen group

Experimental group

Description:

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

Treatment:

Drug: Docetaxel

Docetaxel 3-Weeks regimen group

Active Comparator group

Description:

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

Treatment:

Drug: Docetaxel