A Multicenter, Randomized Clinical Trail Evaluate Effectiveness and Security of Capecitabine or Endocrinotherapy as a Maintenance Therapy Regimen After the 1st-line Chemotherapy With Capecitabine Combine Regimen in Hormone Receptor Positive and HER2

• Status: Unknown status
• Trial end date: 2017-07-01
• Target enrollment: 0
• Participant gender: All

Summary

A multi-sites study about the efficacy of sequential monotherapy: Capecitabine vs. endocrine therapy, in metastatic breast cancer patients with HR-positive & HER2-negative after capecitabine-base chemotherapy.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Zhejiang Cancer Hospital
• Collaborators: 307 Hospital of PLA; Fudan University; Fujian Province Tumor Hospital; Hangzhou Cancer Hospital; Jiangsu Provincial People's Hospital; Sir Run Run Shaw Hospital; The Tumor Hospital of Jiangsu Province; Zhejiang Chinese Medical University; Zhejiang University
• Treatments: Capecitabine; Hormones

Criteria

Inclusion Criteria:

• Signed informed consent

• The age is Above 18 years of age, <70 years old

• HR-positive & HER2-negative

• Metastatic breast cancer,incurable.

• No prior chemotherapy for metastatic recurrence, if there is disease progression within 6 months after the end of the adjuvant chemotherapy, adjuvant chemotherapy as first-line treatment for metastatic lesions

• Eastern Cooperative Oncology Group performance status (ECOG PS)=0~1

• 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:

• Previous toxicity was not recovered to 0-1 degrees

• Central nervous system metastasis

• 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;

• Researchers believe that is not suitable for the study

• Patients with other malignant tumor history, except the healed skin basal cell carcinoma and carcinoma of uterine cervix;

• Bilateral breast cancer