Ignite Creation Date:
2025-12-24 @ 3:06 PM
Ignite Modification Date:
2026-03-04 @ 7:51 PM
Study NCT ID:
NCT02097459
Status:
UNKNOWN
Last Update Posted:
2016-05-25
First Post:
2014-03-19
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prognostic Evaluation of Changing Endocrine Therapy in Women With 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': 'D000077384', 'term': 'Anastrozole'}, {'id': 'D013629', 'term': 'Tamoxifen'}, {'id': 'D017312', 'term': 'Toremifene'}], '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': 'D013267', 'term': 'Stilbenes'}, {'id': 'D001597', 'term': 'Benzylidene Compounds'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 600}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2014-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-05', 'lastUpdateSubmitDate': '2016-05-24', 'studyFirstSubmitDate': '2014-03-19', 'studyFirstSubmitQcDate': '2014-03-24', 'lastUpdatePostDateStruct': {'date': '2016-05-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-03-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2024-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Disease Free Survival', 'timeFrame': '3 years'}, {'measure': 'Overall Survival', 'timeFrame': '3 years'}], 'primaryOutcomes': [{'measure': 'Disease free survival', 'timeFrame': '10 years'}, {'measure': 'Overall Survival', 'timeFrame': '10 years'}], 'secondaryOutcomes': [{'measure': 'Disease Free Survival', 'timeFrame': '5 years'}, {'measure': 'Overall Survival', 'timeFrame': '5 years'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Breast cancer', 'Endocrine therapy', 'Perimenopausal and recently postmenopausal patients', 'Early-stage hormone receptor-positive'], 'conditions': ['Breast Cancer']}, 'descriptionModule': {'briefSummary': 'It suggests in the Guideline that the postmenopausal women with breast cancer who have taken selective estrogen receptor modulators (SERMs) therapy for 2-3 years could benefit from changing endocrine therapy to aromatase inhibitors (AIs). This is a prospective, randomized and non-inferior trial to evaluate the prognosis of changing endocrine therapy from SERMs to AIs in perimenopausal and recently postmenopausal women with early-stage hormone receptor-positive breast cancer.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '45 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Written informed consent must be obtained and documented according to the local regulatory requirements prior to beginning specific protocol procedures.\n* Age of at least 45 and at most 55 years.\n* Performance status (Karnofsky-Index) \\>80%\n* Steroid receptor (estrogen and progesterone) positive tumor (diagnosis according to hospital standard-procedures).\n* No clinical evidence of local recurrence or distant metastases.\n* Complete staging work-up within 3 months prior to registration. All patients must have (bilateral) mammography or breast MRI, chest X-ray; other tests may be performed as clinically indicated.\n* Patients have taken the SERMs as endocrine therapy for 2-4 years.\n* Patients who have had amenorrhea for at least half a year.\n* Life expectancy of at least 10 years, disregarding the diagnosis of cancer.\n* Adequate organ function including normal red and white blood count, platelets, serum creatinine, bilirubin, and transaminases within normal range of the institution.\n* Patients must be available for and compliant to treatment and follow-up.\n* Patients registered on this trial must be treated and followed up at the participating center.\n\nExclusion Criteria:\n\n* Known hypersensitivity reaction to the investigational compounds or incorporated substances.\n* Hormone receptor-negative breast cancer.\n* Local recurrence and/or metastasis of breast cancer.\n* History of hysterectomy.\n* Pregnant or lactating patients. Patients of childbearing potential must have a negative pregnancy test (urine or serum) within 14 days prior to registration.\n* History of osteoporosis and/or fractures due to osteoporosis.\n* Prior or concomitant secondary malignancy (except non-melanomatous skin cancer or carcinoma in situ of the uterine cervix)\n* Any other serious medical pathology, such as congestive heart failure; unstable angina; history of myocardial infarction during the previous year; uncontrolled high risk arrhythmias\n* Other serious illness or medical condition that may interfere with the understanding and giving of informed consent and the conduct of the study.\n* Concurrent treatment with other experimental drugs or any other anti-cancer therapy.\n* Males.'}, 'identificationModule': {'nctId': 'NCT02097459', 'briefTitle': 'Prognostic Evaluation of Changing Endocrine Therapy in Women With Breast Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Peking Union Medical College Hospital'}, 'officialTitle': 'Prognostic Evaluation of Changing Endocrine Therapy in Perimenopausal and Recently Postmenopausal Women With Early-stage Hormone Receptor-Positive Breast Cancer', 'orgStudyIdInfo': {'id': 'PUMCH-BREAST-AI'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Failed group', 'description': 'Patients who have recurrence of menstruation after changing endocrine therapy to anastrozole and then go back to the original SERMs therapy.', 'interventionNames': ['Drug: Anastrozole', 'Drug: Tamoxifen', 'Drug: Toremifene']}, {'type': 'EXPERIMENTAL', 'label': 'Succeeded group', 'description': 'Patients who have no recurrence of menstruation after changing endocrine therapy and then go on with anastrozole therapy.', 'interventionNames': ['Drug: Anastrozole']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'No chang group', 'description': "Patients who don't change the endocrine therapy and go on with the original tamoxifen or toremifene therapy.", 'interventionNames': ['Drug: Tamoxifen', 'Drug: Toremifene']}], 'interventions': [{'name': 'Anastrozole', 'type': 'DRUG', 'otherNames': ['Arimidex'], 'armGroupLabels': ['Failed group', 'Succeeded group']}, {'name': 'Tamoxifen', 'type': 'DRUG', 'armGroupLabels': ['Failed group', 'No chang group']}, {'name': 'Toremifene', 'type': 'DRUG', 'otherNames': ['Fareston', 'Shu Rui'], 'armGroupLabels': ['Failed group', 'No chang group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100730', 'city': 'Beijing', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Qiang Sun, Doctor', 'role': 'CONTACT', 'email': 'birds90@163.com', 'phone': '8610-69152700'}], 'facility': 'Peking Union Medical College Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': 'Qiang Sun, Doctor', 'role': 'CONTACT', 'email': 'birds90@163.com', 'phone': '8610-69152700'}, {'name': 'Yan Lin, Doctor', 'role': 'CONTACT', 'email': 'birds90@163.com', 'phone': '8610-69152700'}], 'overallOfficials': [{'name': 'Qiang Sun, Doctor', 'role': 'STUDY_CHAIR', 'affiliation': 'Peking Union Medical College Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Peking Union Medical College Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Chief of Breast Surgery Department, Professor', 'investigatorFullName': 'Qiang SUN', 'investigatorAffiliation': 'Peking Union Medical College Hospital'}}}}