Capecitabine or Endocrinotherapy as a Maintenance Therapy Regimen at Least 2nd Line in Hormone Receptor Positive and HER2 Negative Metastatic Breast Cancer
- Registration Number
- NCT03204734
- Lead Sponsor
- Zhejiang Cancer Hospital
- 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
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 132
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Capecitabine Capecitabine Capecitabine by mouth twice per day for 14 days, per 21 days as a cycle, until disease progress or toxicity can not be tolerated.Capecitabine starting dose was the dose used at the end of the combined chemotherapy regimen,eg:1000mg per BSA. endocrine therapy endocrine therapy endocrine therapy will been given as a sequential treatment in Metastatic breast cancer patients who are got benefit in capecitabine-base chemotherapy.The medicine will be confirmed by the patient's past-treatment.
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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
Trial Locations
- Locations (1)
Zhejiang Cancer Hospital
🇨🇳Hangzhou, Zhejiang, China