Ignite Creation Date:
2025-12-25 @ 2:29 AM
Ignite Modification Date:
2026-03-09 @ 1:59 PM
Study NCT ID:
NCT03204734
Status:
UNKNOWN
Last Update Posted:
2017-07-02
First Post:
2017-06-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Capecitabine or Endocrinotherapy as a Maintenance Therapy Regimen at Least 2nd Line in Hormone Receptor Positive and HER2 Negative Metastatic Breast Cancer
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': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 132}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2016-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-06', 'completionDateStruct': {'date': '2021-12-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-06-27', 'studyFirstSubmitDate': '2017-06-24', 'studyFirstSubmitQcDate': '2017-06-27', 'lastUpdatePostDateStruct': {'date': '2017-07-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-07-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-12-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'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'}, {'measure': 'overall survival', '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': 'Quality of life(QOL)（1）', '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'}, {'measure': 'Quality of life(QOL)（2）', '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 BR23'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['therapy', 'Capecitabine', 'breast cancer'], 'conditions': ['Breast Cancer']}, 'referencesModule': {'references': [{'pmid': '1922236', 'type': 'BACKGROUND', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': 'Capecitabine-base chemotherapy must be ≥Second-line Therapy'}, '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* 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\n* 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.\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\n* Capecitabine was ineffective in past treatment'}, 'identificationModule': {'nctId': 'NCT03204734', 'briefTitle': 'Capecitabine or Endocrinotherapy as a Maintenance Therapy Regimen at Least 2nd Line in Hormone Receptor Positive and HER2 Negative Metastatic Breast Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Zhejiang Cancer Hospital'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'ZJCH15009'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Capecitabine', 'description': '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.', 'interventionNames': ['Drug: Capecitabine']}, {'type': 'EXPERIMENTAL', 'label': 'endocrine therapy', 'description': "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.", 'interventionNames': ['Drug: endocrine therapy']}], 'interventions': [{'name': 'Capecitabine', 'type': 'DRUG', 'description': 'Capecitabine will been given as a sequential treatment who are got benefit in capecitabine-base chemotherapy.', 'armGroupLabels': ['Capecitabine']}, {'name': 'endocrine therapy', 'type': 'DRUG', 'description': '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.', 'armGroupLabels': ['endocrine therapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '310022', 'city': 'Hangzhou', 'state': 'Zhejiang', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Xiaojia WANG, MD,PhD', 'role': 'CONTACT', 'email': 'wxiaojia0803@163.com', 'phone': '+86 13906500190'}, {'name': 'Ya-bing Zheng, MD', 'role': 'CONTACT', 'email': 'zhengyabing@sina.com', 'phone': '+8613858065353'}], 'facility': 'Zhejiang Cancer Hospital', 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}], 'centralContacts': [{'name': 'Xiao-jia Wang, PHD,MD', 'role': 'CONTACT', 'email': 'wxiaojia0803@163.com', 'phone': '86 13906500190'}, {'name': 'Ya-bing Zheng, MD', 'role': 'CONTACT', 'email': 'zhengyabing@sina.com', 'phone': '13858065353'}], 'overallOfficials': [{'name': 'Xiao-jia Wang, PHD,MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Zhejiang Cance Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Zhejiang Cancer Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Chief Physician', 'investigatorFullName': 'Zhengyabing', 'investigatorAffiliation': 'Zhejiang Cancer Hospital'}}}}