Ignite Creation Date:
2025-12-24 @ 9:06 PM
Ignite Modification Date:
2026-02-21 @ 11:35 PM
Study NCT ID:
NCT02769104
Status:
UNKNOWN
Last Update Posted:
2018-01-09
First Post:
2016-05-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Aromatase Inhibitors Plus Chemotherapy vs Chemotherapy as Neoadjuvant Treatment in Postmenopausal HR(+) 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': 'D000077289', 'term': 'Letrozole'}, {'id': 'D047072', 'term': 'Aromatase Inhibitors'}, {'id': 'D000077143', 'term': 'Docetaxel'}], 'ancestors': [{'id': 'D009570', 'term': 'Nitriles'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D014230', 'term': 'Triazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D065088', 'term': 'Steroid Synthesis Inhibitors'}, {'id': 'D004791', 'term': 'Enzyme Inhibitors'}, {'id': 'D045504', 'term': 'Molecular Mechanisms of Pharmacological Action'}, {'id': 'D020228', 'term': 'Pharmacologic Actions'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}, {'id': 'D004965', 'term': 'Estrogen Antagonists'}, {'id': 'D006727', 'term': 'Hormone Antagonists'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D045505', 'term': 'Physiological Effects of Drugs'}, {'id': 'D043823', 'term': 'Taxoids'}, {'id': 'D043822', 'term': 'Cyclodecanes'}, {'id': 'D003516', 'term': 'Cycloparaffins'}, {'id': 'D006840', 'term': 'Hydrocarbons, Alicyclic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D004224', 'term': 'Diterpenes'}, {'id': 'D013729', 'term': 'Terpenes'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 120}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2016-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-01', 'completionDateStruct': {'date': '2019-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-01-08', 'studyFirstSubmitDate': '2016-05-08', 'studyFirstSubmitQcDate': '2016-05-10', 'lastUpdatePostDateStruct': {'date': '2018-01-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-05-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'effective rate', 'timeFrame': 'half year after randomized', 'description': 'CR+PR'}], 'secondaryOutcomes': [{'measure': 'pCR', 'timeFrame': 'half year after randomized', 'description': 'pathological CR'}, {'measure': 'disease-free survival (DFS)', 'timeFrame': '2 years after randomized', 'description': 'disease-free survival'}, {'measure': 'side effect rate', 'timeFrame': '2 years after randomized'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['aromatase inhibitors', 'chemotherapy', 'neoadjuvant', 'postmenopausal', 'breast cancer'], 'conditions': ['Neoadjuvant Therapy']}, 'descriptionModule': {'briefSummary': 'The investigators designed this study to investigate the effect of aromatase inhibitors (AI) plus chemotherapy versus chemotherapy as neoadjuvant treatment in postmenopausal hormone receptor-positive breast cancer.', 'detailedDescription': 'The endocrine therapy has been used more and more in neoadjuvant treatment of hormone receptor-positive breast cancer. But it still a question if neoadjuvant endocrine therapy can be used combined with chemotherapy. There have been several small-sample studies concerning about this item and also got some results that support the suppose that endocrine therapy combined with chemotherapy could rise the effect of neoadjuvant treatment. This study is to investigate the effect of aromatase inhibitors (AI) plus chemotherapy versus chemotherapy as neoadjuvant treatment in postmenopausal hormone receptor-positive breast cancer.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* provision of informed consent\n* clinical stage IIA\\~IIIC\n* histologically proven HR+ invasive breast cancer\n* women defined as postmenopausal according to NCCN guideline\n* plan to accept the neoadjuvant (pre operational) chemotherapy treatment\n\nExclusion Criteria:\n\n* clinical evidence of metastatic disease\n* bilateral oophorectomy;\n* radiation of the ovaries\n* patients who, for whatever reason (e.g., confusion, infirmity, alcoholism), are unlikely to comply with trial requirements\n* patients who accepted anti-cancer treatment before\n* previous hormonal therapy as adjuvant treatment for non-cancer disease\n* patients unwilling to stop taking any drug known to affect sex hormonal status, or in whom it would be inappropriate to stop\n* previous history of invasive malignancy within the last 5 years, other than squamous or basal cell carcinoma of the skin or carcinoma in situ of the cervix, adequately cone biopsied\n* treatment with a non-approved or experimental drug during 1 month before entry into the study\n* history of bleeding diathesis (i.e., Disseminated intravascular coagulation, clotting factor deficiency), or long term anticoagulant therapy (other than antiplatelet therapy and low dose warfarin)\n* leukopenia and/or thrombocytopenia\n* history of ocular fundus diseases\n* history of thromboembolic diseases\n* history of osteoporotic fractures'}, 'identificationModule': {'nctId': 'NCT02769104', 'acronym': 'ACCN', 'briefTitle': 'Aromatase Inhibitors Plus Chemotherapy vs Chemotherapy as Neoadjuvant Treatment in Postmenopausal HR(+) Breast Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Zhejiang Cancer Hospital'}, 'officialTitle': 'Aromatase Inhibitors (AI) Plus Chemotherapy Versus Chemotherapy as Neoadjuvant Treatment in Postmenopausal Hormone Receptor-positive Breast Cancer', 'orgStudyIdInfo': {'id': 'ZJCH-ACCN'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'AI+Chemo', 'description': 'aromatase inhibitors (Letrozole 2.5mg po. QD for 5 years) starts at the beginning of neoadjuvant treatment combined with chemotherapy (AC\\*4-T\\*4) in patients with postmenopausal hormone receptor-positive breast cancer', 'interventionNames': ['Drug: Letrozole (Aromatase Inhibitors)', 'Drug: AC*4-T*4']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Chemo', 'description': 'chemotherapy (AC\\*4-T\\*4) as neoadjuvant treatment without aromatase inhibitors in patients with postmenopausal hormone receptor-positive breast cancer', 'interventionNames': ['Drug: AC*4-T*4']}], 'interventions': [{'name': 'Letrozole (Aromatase Inhibitors)', 'type': 'DRUG', 'otherNames': ['Letrozole'], 'description': 'Letrozole (Aromatase Inhibitors) for 5 years', 'armGroupLabels': ['AI+Chemo']}, {'name': 'AC*4-T*4', 'type': 'DRUG', 'otherNames': ['CTX+Anthracyclines, Docetaxel'], 'description': 'CTX800mg/m2 d1+Anthracyclines75mg/m2 d1, every 3 weeks\\*4 cycles, be sequential with Docetaxel 75mg/m2 d1, every 3 weeks\\*4cycles', 'armGroupLabels': ['AI+Chemo', 'Chemo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '310022', 'city': 'Hangzhou', 'state': 'Zhejiang', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Hong-Jian Yang, MD.', 'role': 'CONTACT', 'email': 'yhjzlyy@163.com'}, {'name': 'Hong-Jian Yang, MD.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Zhejiang Cancer Hospital', 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}], 'centralContacts': [{'name': 'Hong-Jian Yang, MD.', 'role': 'CONTACT', 'email': 'yhjzlyy@163.com'}], 'overallOfficials': [{'name': 'Hong-Jian Yang, MD.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Zhejiang Cancer Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'The investigators have not decided if the data can be available.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Zhejiang Cancer Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}