Breast Cancer
Conditions
Keywords
therapy, Capecitabine, breast cancer
Brief 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.
Detailed description
capecitabine-base chemotherapy must be first-line chemotherapy.
Interventions
DRUGCapecitabine
Capecitabine is be given as a sequential treatment in Metastatic breast cancer patients who are got benefit in chemo treatment.
PROCEDUREendocrine therapy
endocrine therapy is be given as a sequential treatment in Metastatic breast cancer patients who are got benefit in chemo treatment,the medicine will be confirmed by the patient's past-treatment.
Sponsors
307 Hospital of PLA
Fudan University
The Tumor Hospital of Jiangsu Province
Fujian Province Tumor Hospital
Zhejiang University
Sir Run Run Shaw Hospital
Zhejiang Chinese Medical University
Hangzhou Cancer Hospital
Jiangsu Provincial People's Hospital
Zhejiang Cancer Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Progression-free survival(PFS) | From date of enrolling until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 3 years | Progression-free survival (PFS) is defined as the time elapsed between enrolling and tumor progression or death from any cause |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| clinical benefit rate(CBR) | From date of enrolling until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 3 years | the response is CR+PR+SD ≥ 24 weeks |
Other
| Measure | Time frame | Description |
|---|---|---|
| overall survival(OS) | From date of enrolling until the date of death from any cause, assessed up to 3 years | the time elapsed between enrolling and death from any cause |
| Number of participants with Grade 3/4 adverse events | From date of enrolling until the date of 1 month of stop treatment, assessed up to 3 years | Number of Participants with Grade 3/4 Adverse Events |
| QOL | From date of enrolling until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 3 years | change from enrolling to progression disease or death according EORTC QLQ-C30 and EORTC BR23 |
Countries
China
Contacts
Primary ContactXiaojia - wang, PHD
Backup ContactJian Huang, Doctor
Outcome results
None listed