Ignite Creation Date:
2025-12-24 @ 5:42 PM
Ignite Modification Date:
2026-01-07 @ 3:52 PM
Study NCT ID:
NCT02597868
Status:
UNKNOWN
Last Update Posted:
2016-03-29
First Post:
2014-03-09
Is Gene Therapy:
True
Has Adverse Events:
False
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)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001941', 'term': 'Breast Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069287', 'term': 'Capecitabine'}], 'ancestors': [{'id': 'D003841', 'term': 'Deoxycytidine'}, {'id': 'D003562', 'term': 'Cytidine'}, {'id': 'D011741', 'term': 'Pyrimidine Nucleosides'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D005472', 'term': 'Fluorouracil'}, {'id': 'D014498', 'term': 'Uracil'}, {'id': 'D011744', 'term': 'Pyrimidinones'}, {'id': 'D003853', 'term': 'Deoxyribonucleosides'}, {'id': 'D009705', 'term': 'Nucleosides'}, {'id': 'D009706', 'term': 'Nucleic Acids, Nucleotides, and Nucleosides'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 132}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2013-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-03', 'completionDateStruct': {'date': '2017-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-03-26', 'studyFirstSubmitDate': '2014-03-09', 'studyFirstSubmitQcDate': '2015-11-04', 'lastUpdatePostDateStruct': {'date': '2016-03-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-11-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'overall survival(OS)', 'timeFrame': 'From date of enrolling until the date of death from any cause, assessed up to 3 years', 'description': 'the time elapsed between enrolling and death from any cause'}, {'measure': 'Number of participants with Grade 3/4 adverse events', 'timeFrame': 'From date of enrolling until the date of 1 month of stop treatment, assessed up to 3 years', 'description': 'Number of Participants with Grade 3/4 Adverse Events'}, {'measure': 'QOL', 'timeFrame': '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', 'description': 'change from enrolling to progression disease or death according EORTC QLQ-C30 and EORTC BR23'}], 'primaryOutcomes': [{'measure': 'Progression-free survival(PFS)', 'timeFrame': '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', 'description': 'Progression-free survival (PFS) is defined as the time elapsed between enrolling and tumor progression or death from any cause'}], 'secondaryOutcomes': [{'measure': 'clinical benefit rate(CBR)', 'timeFrame': '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', 'description': 'the response is CR+PR+SD ≥ 24 weeks'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['therapy', 'Capecitabine', 'breast cancer'], 'conditions': ['Breast Cancer']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': 'capecitabine-base chemotherapy must be first-line chemotherapy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Signed informed consent\n* The age is Above 18 years of age, \\<70 years old\n* HR-positive \\& HER2-negative\n* Metastatic breast cancer,incurable.\n* 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\n* Eastern Cooperative Oncology Group performance status (ECOG PS)=0\\~1\n* The basic function of normal bone marrow\n* Functions of liver and kidney is normal\n* Expectation of life is more than 3 months\n* Agreed to take contraceptive measures during treatment\n\nExclusion Criteria:\n\n* Previous toxicity was not recovered to 0-1 degrees\n* Central nervous system metastasis\n* Pregnancy or lactation\n* There are uncontrolled infection, myocardial infarction, thrombosis, etc.\n* There are uncontrolled chronic diseases such as diabetes, hypertension, peptic ulcer, chronic hepatitis, mental disease;\n* Researchers believe that is not suitable for the study\n* Patients with other malignant tumor history, except the healed skin basal cell carcinoma and carcinoma of uterine cervix;\n* Bilateral breast cancer'}, 'identificationModule': {'nctId': 'NCT02597868', 'briefTitle': '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)', 'organization': {'class': 'OTHER', 'fullName': 'Zhejiang Cancer Hospital'}, 'officialTitle': '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)', 'orgStudyIdInfo': {'id': 'ZJCH15003'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Capecitabine', '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.', 'interventionNames': ['Drug: Capecitabine']}, {'type': 'EXPERIMENTAL', 'label': 'endocrine therapy', '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.", 'interventionNames': ['Procedure: endocrine therapy']}], 'interventions': [{'name': 'Capecitabine', 'type': 'DRUG', 'otherNames': ['Xeloda'], 'description': 'Capecitabine is be given as a sequential treatment in Metastatic breast cancer patients who are got benefit in chemo treatment.', 'armGroupLabels': ['Capecitabine']}, {'name': 'endocrine therapy', 'type': 'PROCEDURE', '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.", 'armGroupLabels': ['endocrine therapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '310022', 'city': 'Hangzhou', 'state': 'Zhejiang', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Xiaojia Wang, PHD', 'role': 'CONTACT', 'email': 'wxiaojia0803@163.com', 'phone': '86 13906500190'}, {'name': 'Jian Huang, Doctor', 'role': 'CONTACT', 'email': 'huang_jian22@aliyun.com', 'phone': '86 13588048995'}, {'name': 'Xiaojia Wang, PHD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Zhejiang Cancer Hospital', 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}], 'centralContacts': [{'name': 'Xiaojia - wang, PHD', 'role': 'CONTACT', 'email': 'wxiaojia0803@163.com', 'phone': '86 13906500190'}, {'name': 'Jian Huang, Doctor', 'role': 'CONTACT', 'email': 'huang_jian22@aliyun.com', 'phone': '86 13588048995'}], 'overallOfficials': [{'name': 'Xiaojia Wang, PHD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Zhejiang Cance Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Zhejiang Cancer Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': '307 Hospital of PLA', 'class': 'OTHER'}, {'name': 'Fudan University', 'class': 'OTHER'}, {'name': 'The Tumor Hospital of Jiangsu Province', 'class': 'OTHER'}, {'name': 'Fujian Province Tumor Hospital', 'class': 'OTHER'}, {'name': 'Zhejiang University', 'class': 'OTHER'}, {'name': 'Sir Run Run Shaw Hospital', 'class': 'OTHER'}, {'name': 'Zhejiang Chinese Medical University', 'class': 'OTHER_GOV'}, {'name': 'Hangzhou Cancer Hospital', 'class': 'OTHER'}, {'name': "Jiangsu Provincial People's Hospital", 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}