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 Negative Metastatic Breast Cancer(Overstep)
- Registration Number
- NCT02597868
- Lead Sponsor
- Zhejiang Cancer Hospital
- 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.
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.
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description endocrine therapy endocrine therapy endocrine therapy is be gived as a sequential treatment in Metastatic breast cancer patients who are got benefit in chemotreatment,the medcine will be confirmed by the patient's past-treatment. Capecitabine Capecitabine Capecitabine 1250mg per BSA by mouth twice per day for 14 days, per 21 days as a cycle, until disease progress or toxicity can not be tolerated.
- 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
Trial Locations
- Locations (1)
Zhejiang Cancer Hospital
🇨🇳Hangzhou, Zhejiang, China