Ignite Creation Date:
2025-12-24 @ 10:06 PM
Ignite Modification Date:
2026-01-02 @ 1:25 PM
Study NCT ID:
NCT02646735
Status:
UNKNOWN
Last Update Posted:
2017-01-02
First Post:
2016-01-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Fulvestrant 500mg With Exemestane Endocrine Therapy for Postmenopausal Advanced Breast Cancer Patients
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': 'D000077267', 'term': 'Fulvestrant'}, {'id': 'C056516', 'term': 'exemestane'}], 'ancestors': [{'id': 'D004958', 'term': 'Estradiol'}, {'id': 'D004963', 'term': 'Estrenes'}, {'id': 'D004962', 'term': 'Estranes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D045166', 'term': 'Estradiol Congeners'}, {'id': 'D012739', 'term': 'Gonadal Steroid Hormones'}, {'id': 'D042341', 'term': 'Gonadal Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 148}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2015-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-12', 'completionDateStruct': {'date': '2020-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-12-30', 'studyFirstSubmitDate': '2016-01-04', 'studyFirstSubmitQcDate': '2016-01-04', 'lastUpdatePostDateStruct': {'date': '2017-01-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-01-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'PFS', 'timeFrame': '3 years', 'description': 'To compare the efficacy of Fulvestrant 500 mg with the patients treated with Exemestane 25mg as first line setting in terms of progression-free survival.'}], 'secondaryOutcomes': [{'measure': 'ORR', 'timeFrame': '3 years', 'description': 'To compare the objective response rate of patients treated with Fulvestrant 500 mg with Exemestane.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Breast Cancer']}, 'referencesModule': {'references': [{'pmid': '36905771', 'type': 'DERIVED', 'citation': 'Wang J, Cai L, Song Y, Sun T, Tong Z, Teng Y, Li H, Ouyang Q, Chen Q, Cui S, Yin Y, Liao N, Sun Q, Feng J, Wang X, Xu B. Clinical efficacy of fulvestrant versus exemestane as first-line therapies for Chinese postmenopausal oestrogen-receptor positive /human epidermal growth factor receptor 2 -advanced breast cancer (FRIEND study). Eur J Cancer. 2023 May;184:73-82. doi: 10.1016/j.ejca.2023.02.007. Epub 2023 Feb 15.'}]}, 'descriptionModule': {'briefSummary': 'A Randomized, Open label, Parallel-group, Multi-center study. Eligible patients will be randomized in a 1:1 ratio to receive fulvestrant 500 mg or Exemestane 25mg.', 'detailedDescription': 'To compare the efficacy and tolerability of Fulvestrant 500 mg with Exemestane 25 mg as first line endocrine therapy in postmenopausal women with oestrogen receptor positive HER2 negative advanced breast cancer who have relapsed on or after adjuvant non-aromatase inhibitor therapy'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Signed informed consent document on file;\n* Age over 60 years;\n* Age \\< 60 years and amenorrheic for 12 or more months in the absence of chemotherapy, tamoxifen, toremifene, or ovarian suppression and FSH and oestradiol level in the postmenopausal range;\n* Patients with metastatic or locally advanced disease not amenable to therapy with Curative intent\n* ER + and/or PgR +;\n* Duration of adjuvant non-aromatase inhibitors treatment should be at least 2 years or more;\n* WHO performance status 0, 1 or 2;\n* Patients with life expectancy of more than 3 months.\n\nExclusion Criteria:\n\n* Presence of life-threatening metastatic visceral disease;\n* Previous systemic chemotherapy for advanced breast cancer;\n* Received systemic endocrine therapy for advanced disease;\n* Extensive radiation therapy within the last 4 weeks ;\n* Platelets \\< 100\\*109 / L,Total bilirubin no less than 1.5ULRR, ALT or AST no less than 2.5ULRR if no demonstrable liver metastases or no less than 5ULRR in presence of liver metastases;\n* Severe renal impairment, bleeding diathesis, long-term anticoagulant therapy;\n* History of hypersensitivity to active or inactive excipients of fulvestrant, Exemestane and/or castor oil.'}, 'identificationModule': {'nctId': 'NCT02646735', 'acronym': 'FRIEND', 'briefTitle': 'Fulvestrant 500mg With Exemestane Endocrine Therapy for Postmenopausal Advanced Breast Cancer Patients', 'organization': {'class': 'UNKNOWN', 'fullName': 'ChineseAMS'}, 'officialTitle': 'A Randomized, Open Label, Multi-Centre Study to Compare the Efficacy and Tolerability of Fulvestrant 500mg With Exemestane for Postmenopausal Advanced Breast Cancer Patients', 'orgStudyIdInfo': {'id': '10982'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Fulvestrant', 'description': 'Fulvestrant 500 mg', 'interventionNames': ['Drug: Fulvestrant 500 mg']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Exemestane', 'description': 'Exemestane 25mg', 'interventionNames': ['Drug: Exemestane 25 mg']}], 'interventions': [{'name': 'Fulvestrant 500 mg', 'type': 'DRUG', 'description': 'Fulvestrant 500mg will be given monthly.', 'armGroupLabels': ['Fulvestrant']}, {'name': 'Exemestane 25 mg', 'type': 'DRUG', 'description': 'Exemestane 25mg will be given once daily.', 'armGroupLabels': ['Exemestane']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100021', 'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Binghe XU, M.D.', 'role': 'CONTACT', 'email': 'xubinghe@medmail.com.cn', 'phone': '86-10-88788826'}, {'name': 'Jiayu WANG, M.D.', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'National Cancer Institute, Cancer Hospital Chinese Academy of Medical Sciences', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': 'XU Binghe, MD', 'role': 'CONTACT', 'email': 'wangjiayu8778@sina.com', 'phone': '86-10-87788495', 'phoneExt': '0000'}, {'name': 'WANG Jiayu, MD', 'role': 'CONTACT', 'email': 'wangjiayu8778@sina.com', 'phone': '86-10-87788495', 'phoneExt': '0000'}], 'overallOfficials': [{'name': 'XU Binghe, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Chinese Academy of Medical Sciences'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chinese Academy of Medical Sciences', 'class': 'OTHER'}, 'collaborators': [{'name': 'Cancer Institute and Hospital, Chinese Academy of Medical Sciences', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Head of the medical department', 'investigatorFullName': 'Binghe Xu', 'investigatorAffiliation': 'Chinese Academy of Medical Sciences'}}}}