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

• Status: Unknown status
• Trial end date: 2019-12-30
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Zhejiang Cancer Hospital
• Treatments: Docetaxel

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