Back to resultsA 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)
Primary Purpose
Breast Cancer
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Capecitabine
endocrine therapy
Sponsored by
About this trial
This is an interventional treatment trial for Breast Cancer focused on measuring therapy, Capecitabine, breast cancer
Eligibility Criteria
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
Sites / Locations
- Zhejiang Cancer HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Capecitabine
endocrine therapy
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Progression-free survival(PFS)
Progression-free survival (PFS) is defined as the time elapsed between enrolling and tumor progression or death from any cause
Secondary Outcome Measures
clinical benefit rate(CBR)
the response is CR+PR+SD ≥ 24 weeks
Full Information
NCT ID
NCT02597868
First Posted
March 9, 2014
Last Updated
March 26, 2016
Sponsor
Zhejiang Cancer Hospital
Collaborators
307 Hospital of PLA, Fudan University, The Tumor Hospital of Jiangsu Province, Fujian Province Tumor Hospital, Zhejiang University, Sir Run Run Shaw Hospital, Zhejiang Chinese Medical University, Hangzhou Cancer Hospital, Jiangsu Provincial People's Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02597868
Brief Title
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)
Official Title
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 Type
Interventional
2. Study Status
Record Verification Date
March 2016
Overall Recruitment Status
Unknown status
Study Start Date
January 2013 (undefined)
Primary Completion Date
July 2016 (Anticipated)
Study Completion Date
July 2017 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Zhejiang Cancer Hospital
Collaborators
307 Hospital of PLA, Fudan University, The Tumor Hospital of Jiangsu Province, Fujian Province Tumor Hospital, Zhejiang University, Sir Run Run Shaw Hospital, Zhejiang Chinese Medical University, Hangzhou Cancer Hospital, Jiangsu Provincial People's Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
therapy, Capecitabine, breast cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
132 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Capecitabine
Arm Type
Active Comparator
Arm Description
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.
Arm Title
endocrine therapy
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Capecitabine
Other Intervention Name(s)
Xeloda
Intervention Description
Capecitabine is be given as a sequential treatment in Metastatic breast cancer patients who are got benefit in chemo treatment.
Intervention Type
Procedure
Intervention Name(s)
endocrine therapy
Intervention Description
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.
Primary Outcome Measure Information:
Title
Progression-free survival(PFS)
Description
Progression-free survival (PFS) is defined as the time elapsed between enrolling and tumor progression or death from any cause
Time Frame
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 Measure Information:
Title
clinical benefit rate(CBR)
Description
the response is CR+PR+SD ≥ 24 weeks
Time Frame
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
Other Pre-specified Outcome Measures:
Title
overall survival(OS)
Description
the time elapsed between enrolling and death from any cause
Time Frame
From date of enrolling until the date of death from any cause, assessed up to 3 years
Title
Number of participants with Grade 3/4 adverse events
Description
Number of Participants with Grade 3/4 Adverse Events
Time Frame
From date of enrolling until the date of 1 month of stop treatment, assessed up to 3 years
Title
QOL
Description
change from enrolling to progression disease or death according EORTC QLQ-C30 and EORTC BR23
Time Frame
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xiaojia - wang, PHD
Phone
86 13906500190
Email
wxiaojia0803@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Jian Huang, Doctor
Phone
86 13588048995
Email
huang_jian22@aliyun.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xiaojia Wang, PHD
Organizational Affiliation
Zhejiang Cance Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Zhejiang Cancer Hospital
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310022
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiaojia Wang, PHD
Phone
86 13906500190
Email
wxiaojia0803@163.com
First Name & Middle Initial & Last Name & Degree
Jian Huang, Doctor
Phone
86 13588048995
Email
huang_jian22@aliyun.com
First Name & Middle Initial & Last Name & Degree
Xiaojia Wang, PHD
12. IPD Sharing Statement
Learn more about this trial
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)
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