Capecitabine or Endocrinotherapy as a Maintenance Therapy Regimen at Least 2nd Line in Hormone Receptor Positive and HER2 Negative Metastatic Breast Cancer
NCT ID: NCT03204734
Last Updated: 2017-07-02
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
PHASE2
132 participants
INTERVENTIONAL
2016-01-01
2021-12-30
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 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.
Capecitabine
Capecitabine will been given as a sequential treatment who are got benefit in capecitabine-base chemotherapy.
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.
endocrine therapy
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.
Interventions
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Capecitabine
Capecitabine will been given as a sequential treatment who are got benefit in capecitabine-base chemotherapy.
endocrine therapy
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.
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.
* 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
* 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
18 Years
70 Years
ALL
No
Sponsors
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Zhejiang Cancer Hospital
OTHER
Responsible Party
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Zhengyabing
Chief Physician
Principal Investigators
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Xiao-jia Wang, PHD,MD
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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References
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Muss HB, Case LD, Richards F 2nd, White DR, Cooper MR, Cruz JM, Powell BL, Spurr CL, Capizzi RL. Interrupted versus continuous chemotherapy in patients with metastatic breast cancer. The Piedmont Oncology Association. N Engl J Med. 1991 Nov 7;325(19):1342-8. doi: 10.1056/NEJM199111073251904.
Other Identifiers
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ZJCH15009
Identifier Type: -
Identifier Source: org_study_id
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