Overview

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