Ignite Creation Date:
2025-12-24 @ 11:18 PM
Ignite Modification Date:
2026-02-22 @ 5:08 PM
Study NCT ID:
NCT01492556
Status:
UNKNOWN
Last Update Posted:
2013-03-15
First Post:
2011-12-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of Etoposide in Treating Patients With Recurrent or Metastatic Breast Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}, {'id': 'D012008', 'term': 'Recurrence'}, {'id': 'D009362', 'term': 'Neoplasm Metastasis'}], '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'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D009385', 'term': 'Neoplastic Processes'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D005047', 'term': 'Etoposide'}], 'ancestors': [{'id': 'D011034', 'term': 'Podophyllotoxin'}, {'id': 'D013764', 'term': 'Tetrahydronaphthalenes'}, {'id': 'D009281', 'term': 'Naphthalenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D005960', 'term': 'Glucosides'}, {'id': 'D006027', 'term': 'Glycosides'}, {'id': 'D002241', 'term': 'Carbohydrates'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2011-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-03', 'completionDateStruct': {'date': '2015-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2013-03-14', 'studyFirstSubmitDate': '2011-12-12', 'studyFirstSubmitQcDate': '2011-12-13', 'lastUpdatePostDateStruct': {'date': '2013-03-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-12-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Progression-free survival', 'timeFrame': 'Up to 1 year'}], 'secondaryOutcomes': [{'measure': 'Clinical response rate', 'timeFrame': 'Every six weeks', 'description': 'Assessed by RECIST v1.1 criteria.'}, {'measure': '1-year survival rate', 'timeFrame': 'Up to 1 year'}, {'measure': 'Adverse events', 'timeFrame': 'Subjects will be followed from date of enrollment until the date of last visit, expected up to 1 year'}, {'measure': 'Quality of Life', 'timeFrame': 'Every six weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Recurrent', 'Metastatic', 'Breast cancer'], 'conditions': ['Breast Cancer']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether Etoposide Monotherapy is effective and safe in the treatment of recurrent or metastatic breast cancer in Chinese female patients.', 'detailedDescription': 'Current recommended dosage of Etoposide in treating breast cancer is 50 mg/m2 orally once a day for 21 days, repeated every 28 days. With retrospective data review, this study intends to adjust Etoposide dose to 60 mg/m2 daily for 10 days, repeated every 21 days as a cycle, to investigate the effectiveness and safety of Etoposide monotherapy in the treatment of recurrent or metastatic breast cancer in Chinese female patients.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age: 18-80 years old.\n* ECOG status: 0-2.\n* Histologic or cytologic diagnosis of locally advanced or metastatic breast cancer.\n* No more than three prior chemotherapies, adjuvant chemotherapy excluded.\n* Received prior anthracycline, taxane therapy.\n* At least 4 weeks from previous chemotherapy.\n* Measurable disease of \\>=2 cm (\\>=1 cm on spiral CT scan).\n* Life expectancy of ≥ 3 months.\n* Adequate organ functions:\n\n * Hemoglobin ≥10.0 g/dl, Absolute neutrophil count ≥1.5×10\\^9/L, Platelet count ≥100×10\\^9/L,\n * Creatinine clearance ≥60ml/min,\n * Bilirubin ≤1.5 times upper limit of normal (ULN); AKP,AST and ALT ≤2.5x ULN(≤5x ULN if due to liver metastases).\n* Signed informed consent.\n* Menopausal women or received surgical sterilization, women with children potential must not be pregnant or nursing with negative pregnancy test and willing to practice acceptable methods of birth control during the study and 3 months after the study.\n\nExclusion Criteria:\n\n* Pregnancy or lactation.\n* Untreated or uncontrolled CNS metastases, or with refractory psychiatric illness.\n* Prior treatment with Etoposide.\n* Other primary malignancies within the past 5 years except for carcinoma in situ of the cervix or nonmelanoma skin cancer.\n* Clinically significant heart diseases (e.g.congestive heart failure, symptomatic coronary disease, uncontrolled cardiac arrhythmia, Myocardial infarction) within the past 12 months.\n* Serious uncontrolled concurrent infection or metabolism disorder.\n* Concurrent treatment for active peptic ulcer disease or with digestive disorders.\n* Prior radiotherapy and major surgery within 3 weeks before screening.\n* Less than 4 weeks since prior investigational agents.\n* Metastases present in more than one-third whole liver.\n* Unable or unwilling to comply with the study protocol.\n* Unsuitable to participate in study, that in the opinion of the treating physician.'}, 'identificationModule': {'nctId': 'NCT01492556', 'briefTitle': 'Study of Etoposide in Treating Patients With Recurrent or Metastatic Breast Cancer', 'organization': {'class': 'UNKNOWN', 'fullName': 'ChineseAMS'}, 'officialTitle': 'A Phase II, Single-arm, Multicenter Study of Etoposide Monotherapy in Treating Patients With Recurrent or Metastatic Breast Cancer', 'orgStudyIdInfo': {'id': 'CH-BC-015'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Etoposide', 'description': 'Etoposide Capsules', 'interventionNames': ['Drug: Etoposide']}], 'interventions': [{'name': 'Etoposide', 'type': 'DRUG', 'otherNames': ['Lastet, VP-16'], 'description': 'Lastet (Etoposide Capsules, 25mg\\*40 capsules/box), manufactured by Nippon Kayaku Co., Ltd.', 'armGroupLabels': ['Etoposide']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100005', 'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Li Ding, MD', 'role': 'CONTACT', 'email': 'zhangygqg@yahoo.com.cn', 'phone': '+86-13701314630'}, {'name': 'Yongqiang Zhang, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Li Ding, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Beijing Hospital of the Ministry of Health', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'zip': '100005', 'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Changjun Wang, MD', 'role': 'CONTACT', 'email': 'wangchangjun.cannei@gmail.com', 'phone': '+86-10-6915-8936'}, {'name': 'Qiang Sun, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Changjun Wang, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Peking Union Medical College Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'zip': '100020', 'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Dan Yu, MD', 'role': 'CONTACT', 'email': 'xiaoyugw@126.com', 'phone': '+86-13810292522'}, {'name': 'Dan Yu, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Guangyu An, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Beijing Chao-yang Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'zip': '100021', 'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Peng Yuan, M.D.', 'role': 'CONTACT', 'email': 'yuanpeng01@hotmail.com', 'phone': '86-10-8778-8114'}, {'name': 'Binghe Xu, M.D., Ph.D', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Peng Yuan, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Cancer Institute and Hospital, Chinese Academy of Medical Sciences', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'zip': '100029', 'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Donggui Wan, MD', 'role': 'CONTACT', 'email': 'dongguiwan@263.net', 'phone': '+86-13601365686'}, {'name': 'Liqun Jia, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Donggui Wan, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'China-Japan Friendship Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'zip': '100142', 'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Ying Yan, MD', 'role': 'CONTACT', 'email': 'yan99640815@yahoo.com.cn', 'phone': '+86-13141316976'}, {'name': 'Lijun Di, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Ying Yan, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Peking University Cancer Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'zip': '530021', 'city': 'Nanning', 'state': 'Guangxi', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Hongxue Wang, MD', 'role': 'CONTACT', 'phone': '+86-13978806626'}, {'name': 'Wei Wei, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Hongxue Wang, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Guangxi Cancer Hospital', 'geoPoint': {'lat': 22.81667, 'lon': 108.31667}}, {'zip': '150081', 'city': 'Harbin', 'state': 'Heilongjiang', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Qingyuan Zhang, MD', 'role': 'CONTACT', 'phone': '86-451-86298800'}, {'name': 'Qingyuan Zhang, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Harbin Medical University Cancer Hospital', 'geoPoint': {'lat': 45.75, 'lon': 126.65}}, {'zip': '450008', 'city': 'Zhengzhou', 'state': 'Henan', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Min Yan, MD', 'role': 'CONTACT', 'email': 'ym200678@126.com', 'phone': '+86-13673641112'}, {'name': 'Shujun Yang, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Min Yan, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Henan Cancer Hospital', 'geoPoint': {'lat': 34.75778, 'lon': 113.64861}}, {'zip': '116011', 'city': 'Dalian', 'state': 'Liaoning', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Weiwei Gong, MD', 'role': 'CONTACT', 'email': 'gongweiwei12@163.com', 'phone': '+86-18941197930'}, {'name': 'Li Li, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Weiwei Gong, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'First Affiliated Hospital of Dalian Medical University', 'geoPoint': {'lat': 38.91222, 'lon': 121.60222}}, {'zip': '200030', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Qi He, MD', 'role': 'CONTACT', 'phone': '+86-13801858957'}, {'name': 'Qi He, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'International Peace Maternity & Child Health Hospital of the China Welfare Institute', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'zip': '200062', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Qi Zhu, MD', 'role': 'CONTACT', 'phone': '+86-13301679760'}, {'name': 'Miaoqian Liang, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Qi Zhu, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Shanghai Putuo District Center Hospital', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'zip': '830011', 'city': 'Ürümqi', 'state': 'Xinjiang', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Duo Ni, MD', 'role': 'CONTACT', 'phone': '+86-13909926820'}, {'name': 'Duo Ni, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Affiliated Cancer Hospital of Xinjiang Medical University', 'geoPoint': {'lat': 43.80096, 'lon': 87.60046}}, {'zip': '310022', 'city': 'Hangzhou', 'state': 'Zhejiang', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Jufen Cai, MD', 'role': 'CONTACT', 'email': 'CaiJf108@126.com', 'phone': '+86-13867168680'}, {'name': 'Jufen Cai, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Zhejiang Cancer Hospital', 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}], 'centralContacts': [{'name': 'Peng Yuan, M.D.', 'role': 'CONTACT', 'email': 'yuanpeng01@hotmail.com', 'phone': '86-10-8778-8114'}], 'overallOfficials': [{'name': 'Binghe Xu, M.D., Ph.D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Chinese Academy of Medical Sciences'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chinese Academy of Medical Sciences', 'class': 'OTHER'}, 'collaborators': [{'name': 'Peking University Cancer Hospital & Institute', 'class': 'OTHER'}, {'name': 'Peking Union Medical College Hospital', 'class': 'OTHER'}, {'name': 'Beijing Chao Yang Hospital', 'class': 'OTHER'}, {'name': 'China-Japan Friendship Hospital', 'class': 'OTHER'}, {'name': 'Beijing Hospital of the Ministry of Health', 'class': 'UNKNOWN'}, {'name': 'The First Affiliated Hospital of Dalian Medical University', 'class': 'OTHER'}, {'name': 'The Second Affiliated Hospital of Harbin Medical University', 'class': 'OTHER'}, {'name': 'Zhejiang Cancer Hospital', 'class': 'OTHER'}, {'name': 'Henan Cancer Hospital', 'class': 'OTHER_GOV'}, {'name': 'Guangxi Cancer Hospital', 'class': 'UNKNOWN'}, {'name': 'Shanghai Putuo District Center Hospital', 'class': 'OTHER'}, {'name': 'International Peace Maternity and Child Health Hospital', 'class': 'OTHER'}, {'name': 'Xinjiang Medical University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Deputy Director of Department of Medical Oncology', 'investigatorFullName': 'Binghe Xu', 'investigatorAffiliation': 'Chinese Academy of Medical Sciences'}}}}