Capecitabine or Endocrinotherapy as a Maintenance Therapy Regimen at Least 2nd Line in Hormone Receptor Positive and HER2 Negative Metastatic Breast Cancer

Study Overview
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Brief Summary
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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
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Capecitabine-base chemotherapy must be ≥Second-line Therapy

Official Title
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Evaluate Effectiveness and Security of Capecitabine or Endocrinotherapy as a Maintenance Therapy Regimen After 2nd-line or Over 2nd-line Therapy With Capecitabine Combine Regimen in Hormone Receptor Positive and HER2 Negative Metastatic Breast Cancer

Conditions
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Breast Cancer

Intervention / Treatment
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* Drug: Capecitabine
* Drug: 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. 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

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 |
| --- | --- |
| Experimental: Capecitabine<br>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. | Drug: Capecitabine<br>* Capecitabine will been given as a sequential treatment who are got benefit in capecitabine-base chemotherapy.<br>|
| Experimental: endocrine therapy<br>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. | Drug: endocrine therapy<br>* 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.<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 | 
| overall survival | the time elapsed between enrolling and death from any cause | From date of enrolling until the date of death from any cause, assessed up to 3 years | 
| Number of participants with Grade 3/4 adverse events | 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 | 
| Quality of life(QOL)（1） | change from enrolling to progression disease or death according EORTC QLQ-C30 | 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 | 
| Quality of life(QOL)（2） | change from enrolling to progression disease or death according EORTC BR23 | 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