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)

Study Overview
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Brief Summary
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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
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capecitabine-base chemotherapy must be first-line chemotherapy.

Official Title
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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)

Conditions
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Breast Cancer

Intervention / Treatment
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* Drug: Capecitabine
* Procedure: endocrine therapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Capecitabine<br>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. | Drug: Capecitabine<br>* Capecitabine is be given as a sequential treatment in Metastatic breast cancer patients who are got benefit in chemo treatment.<br>* Other names: Xeloda;|
| Experimental: endocrine therapy<br>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. | Procedure: endocrine therapy<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression-free survival(PFS) | Progression-free survival (PFS) is defined as the time elapsed between enrolling and tumor progression or death from any cause | 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| clinical benefit rate(CBR) | the response is CR+PR+SD ≥ 24 weeks | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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therapy, Capecitabine, breast cancer