Breast Cancer
Conditions
Keywords
therapy, Capecitabine, breast cancer
Brief summary
A single-site 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 ≥Second-line Therapy
Interventions
DRUGCapecitabine
Capecitabine will been given as a sequential treatment who are got benefit in capecitabine-base chemotherapy.
DRUGendocrine therapy
endocrine therapy will been given as a sequential treatment who are got benefit in capecitabine-base chemotherapy.Endocrine therapy is determined by the doctor, including any kind of letrozole, anastrozole, exemestane, fulvestrant, tamoxifen, toremifene, combined with or without drugs or surgery in the inhibition of ovarian function.
Sponsors
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. * For recurrent or metastatic lesions has had at least 1 but no more than 3 kinds of chemotherapy, if there is disease progression within 6 months after the end of the adjuvant chemotherapy, adjuvant chemotherapy will been the first-line treatment for metastatic lesions * No prior use of capecitabine therapy or the use of capecitabine treatment was effective, and the efficacy evaluation was CR/PR/SD more than 6 months. * 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 * Capecitabine was ineffective in past treatment
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 |
| overall survival | 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 |
| Quality of life(QOL)（1） | 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 |
| Quality of life(QOL)（2） | 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 BR23 |
Countries
China
Contacts
Primary ContactXiao-jia Wang, PHD,MD
Backup ContactYa-bing Zheng, MD
Outcome results
None listed