Ignite Creation Date:
2025-12-24 @ 6:59 PM
Ignite Modification Date:
2026-02-20 @ 6:42 PM
Study NCT ID:
NCT02615457
Status:
UNKNOWN
Last Update Posted:
2015-11-26
First Post:
2015-11-17
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Huaier Granule in Treating Women With Triple Negative Breast Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D064726', 'term': 'Triple Negative Breast Neoplasms'}], 'ancestors': [{'id': 'D001943', 'term': 'Breast Neoplasms'}, {'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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 300}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2015-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-11', 'lastUpdateSubmitDate': '2015-11-24', 'studyFirstSubmitDate': '2015-11-17', 'studyFirstSubmitQcDate': '2015-11-24', 'lastUpdatePostDateStruct': {'date': '2015-11-26', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-11-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2025-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Disease free survival (DFS)', 'timeFrame': 'Up to 10 years', 'description': 'Time from randomization to recurrence, metastasis, appearance of a second primary tumor, or death from any cause, whichever occurs first, assessed up to 10 years.'}], 'secondaryOutcomes': [{'measure': 'Overall survival (OS)', 'timeFrame': 'Up to 10 years', 'description': 'Time from randomization to death from any cause, assessed up to 10 years.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Triple Negative Breast Cancer']}, 'referencesModule': {'references': [{'pmid': '26134510', 'type': 'BACKGROUND', 'citation': 'Wang X, Qi W, Li Y, Zhang N, Dong L, Sun M, Cun J, Zhang Y, Lv S, Yang Q. Huaier Extract Induces Autophagic Cell Death by Inhibiting the mTOR/S6K Pathway in Breast Cancer Cells. PLoS One. 2015 Jul 2;10(7):e0131771. doi: 10.1371/journal.pone.0131771. eCollection 2015.'}, {'pmid': '25955759', 'type': 'BACKGROUND', 'citation': 'Song X, Li Y, Zhang H, Yang Q. The anticancer effect of Huaier (Review). Oncol Rep. 2015 Jul;34(1):12-21. doi: 10.3892/or.2015.3950. Epub 2015 May 5.'}, {'pmid': '25826742', 'type': 'BACKGROUND', 'citation': 'Kong X, Ding X, Yang Q. Identification of multi-target effects of Huaier aqueous extract via microarray profiling in triple-negative breast cancer cells. Int J Oncol. 2015 May;46(5):2047-56. doi: 10.3892/ijo.2015.2932. Epub 2015 Mar 17.'}, {'pmid': '25077927', 'type': 'BACKGROUND', 'citation': 'Wang X, Zhang N, Huo Q, Sun M, Dong L, Zhang Y, Xu G, Yang Q. Huaier aqueous extract inhibits stem-like characteristics of MCF7 breast cancer cells via inactivation of hedgehog pathway. Tumour Biol. 2014 Nov;35(11):10805-13. doi: 10.1007/s13277-014-2390-2. Epub 2014 Jul 31.'}, {'pmid': '23686317', 'type': 'BACKGROUND', 'citation': 'Wang X, Zhang N, Huo Q, Sun M, Lv S, Yang Q. Huaier aqueous extract suppresses human breast cancer cell proliferation through inhibition of estrogen receptor alpha signaling. Int J Oncol. 2013 Jul;43(1):321-8. doi: 10.3892/ijo.2013.1947. Epub 2013 May 20.'}, {'pmid': '22895629', 'type': 'BACKGROUND', 'citation': 'Wang X, Zhang N, Huo Q, Yang Q. Anti-angiogenic and antitumor activities of Huaier aqueous extract. Oncol Rep. 2012 Oct;28(4):1167-75. doi: 10.3892/or.2012.1961. Epub 2012 Aug 8.'}, {'pmid': '20718753', 'type': 'BACKGROUND', 'citation': 'Zhang N, Kong X, Yan S, Yuan C, Yang Q. Huaier aqueous extract inhibits proliferation of breast cancer cells by inducing apoptosis. Cancer Sci. 2010 Nov;101(11):2375-83. doi: 10.1111/j.1349-7006.2010.01680.x.'}]}, 'descriptionModule': {'briefSummary': 'RATIONALE:\n\nHuaier (Trametes robiniophila Murr) is a traditional Chinese medicine, which has been widely used in China for many years. The investigators previous study has reported that Huaier could exert great inhibitory effects on breast cancer cells both in vitro and in vivo.\n\nPURPOSE:\n\nTo evaluate the efficacy and safety of Huaier Granule in treating women who have triple negative breast cancer that has been surgically removed.', 'detailedDescription': 'OBJECTIVES:\n\nCompare the disease-free survival (DFS) and overall survival (OS) of patients with triple negative breast cancer who are randomized to adjuvant Huaier Granule group vs. those randomized to Blank-control group.\n\nOUTLINE:\n\nPatients are randomized to the following one of two treatment groups and are followed annually.\n\nArm I: Patients taking Huaier Granule for adjuvant treatment after the triple negative breast cancer has been surgically removed.\n\nArm II: Patients not taking Huaier Granule after the triple negative breast cancer has been surgically removed.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age: ≥ 18 and ≤ 75 years, female;\n* Triple negative breast cancer has been surgically removed;\n* The triple negative breast cancer has been confirmed by pathological examination and Immunohistochemistry (IHC);\n* Not receiving any preoperative anticancer drugs;\n* The liver and kidney function satisfies the following conditions within 3 days after surgery (excluding day 3): aspartate aminotransferase (AST), glutamic-oxalacetic transaminase (ALT) \\< 2 upper limit of normal (ULN), total bilirubin ≤ 1.5 ULN, serum creatinine \\< 1.5 ULN;\n* Other laboratory tests meet the following requirements within 3 days after surgery (excluding day 3): Hb ≥ 90g/l, platelet count ≥ 100×109/L, absolute neutrophil count \\> 1.5×109/L;\n* The expected survival time ≥ 6 months;\n* The subjects volunteer to sign the informed consent.\n\nExclusion Criteria:\n\n* Patients with stage IV breast cancer;\n* Triple negative breast cancer was not surgically removed;\n* Non-triple negative breast cancer patients confirmed by pathological examination and Immunohistochemistry (IHC);\n* Pregnant or lactating women;\n* Those with active bleeding due to various reasons;\n* Those with HIV infection or AIDS-associated diseases;\n* Those with severe acute and chronic diseases;\n* Those with severe diabetes;\n* Those with serious infectious diseases;\n* Those who can not take drugs by oral route;\n* Drug abusers or those with psychological or mental diseases that may interfere with study compliance;\n* Conditions that are considered not suitable for this study investigators'}, 'identificationModule': {'nctId': 'NCT02615457', 'briefTitle': 'Huaier Granule in Treating Women With Triple Negative Breast Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Shandong University'}, 'orgStudyIdInfo': {'id': 'HECT001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Arm I', 'description': 'Patients taking Huaier Granule for adjuvant treatment after the triple negative breast cancer has been surgically removed. The Huaier Granule (Qidong Gaitianli Medicines Co., Ltd.) should be given orally from the 3rd day after surgery up to 5 years after surgery or until study termination.', 'interventionNames': ['Drug: Huaier Granule']}, {'type': 'NO_INTERVENTION', 'label': 'Arm II', 'description': 'Patients not taking Huaier Granule after the triple negative breast cancer has been surgically removed.'}], 'interventions': [{'name': 'Huaier Granule', 'type': 'DRUG', 'description': 'Huaier Granule was given orally, 20 g tid for 5 years.', 'armGroupLabels': ['Arm I']}]}, 'contactsLocationsModule': {'locations': [{'zip': '250012', 'city': "Ji'nan", 'state': 'Shandong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Qifeng Yang, Professor', 'role': 'CONTACT', 'phone': '+86 18560085168'}], 'facility': 'Qilu hospital of Shandong University'}], 'centralContacts': [{'name': 'Qifeng Yang, Professor', 'role': 'CONTACT', 'email': 'qifengy_sdu@163.com', 'phone': '+8618560085168'}, {'name': 'Ning Zhang, Resident', 'role': 'CONTACT', 'email': 'zhangning0816@163.com', 'phone': '+8618560085950'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shandong University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Qifeng Yang', 'investigatorAffiliation': 'Shandong University'}}}}