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)
NCT ID: NCT02597868
Last Updated: 2016-03-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
132 participants
INTERVENTIONAL
2013-01-31
2017-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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.
Capecitabine
Capecitabine is be given as a sequential treatment in Metastatic breast cancer patients who are got benefit in chemo treatment.
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.
endocrine therapy
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.
Interventions
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Capecitabine
Capecitabine is be given as a sequential treatment in Metastatic breast cancer patients who are got benefit in chemo treatment.
endocrine therapy
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
70 Years
ALL
No
Sponsors
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307 Hospital of PLA
OTHER
Fudan University
OTHER
The Tumor Hospital of Jiangsu Province
OTHER
Fujian Province Tumor Hospital
OTHER
Zhejiang University
OTHER
Sir Run Run Shaw Hospital
OTHER
Zhejiang Chinese Medical University
OTHER_GOV
Hangzhou Cancer Hospital
OTHER
Jiangsu Provincial People's Hospital
OTHER
Zhejiang Cancer Hospital
OTHER
Responsible Party
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Principal Investigators
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Xiaojia Wang, PHD
Role: PRINCIPAL_INVESTIGATOR
Zhejiang Cance Hospital
Locations
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Zhejiang Cancer Hospital
Hangzhou, Zhejiang, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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ZJCH15003
Identifier Type: -
Identifier Source: org_study_id
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