Ignite Creation Date:
2025-12-25 @ 3:24 AM
Ignite Modification Date:
2026-02-01 @ 3:14 AM
Study NCT ID:
NCT01503905
Status:
UNKNOWN
Last Update Posted:
2016-05-24
First Post:
2011-12-29
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Neoadjuvant Chemotherapy for Operable Premenopausal Breast Cancer Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}, {'id': 'D000568', 'term': 'Amenorrhea'}], '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': 'D008599', 'term': 'Menstruation Disturbances'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077143', 'term': 'Docetaxel'}, {'id': 'D015251', 'term': 'Epirubicin'}, {'id': 'D003520', 'term': 'Cyclophosphamide'}, {'id': 'D015411', 'term': 'Mastectomy, Modified Radical'}, {'id': 'D015412', 'term': 'Mastectomy, Segmental'}, {'id': 'D011184', 'term': 'Postoperative Period'}, {'id': 'D011878', 'term': 'Radiotherapy'}, {'id': 'D013629', 'term': 'Tamoxifen'}], 'ancestors': [{'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': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D004224', 'term': 'Diterpenes'}, {'id': 'D013729', 'term': 'Terpenes'}, {'id': 'D004317', 'term': 'Doxorubicin'}, {'id': 'D003630', 'term': 'Daunorubicin'}, {'id': 'D018943', 'term': 'Anthracyclines'}, {'id': 'D009279', 'term': 'Naphthacenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D000617', 'term': 'Aminoglycosides'}, {'id': 'D006027', 'term': 'Glycosides'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D010752', 'term': 'Phosphoramide Mustards'}, {'id': 'D009588', 'term': 'Nitrogen Mustard Compounds'}, {'id': 'D009150', 'term': 'Mustard Compounds'}, {'id': 'D006846', 'term': 'Hydrocarbons, Halogenated'}, {'id': 'D063088', 'term': 'Phosphoramides'}, {'id': 'D009943', 'term': 'Organophosphorus Compounds'}, {'id': 'D015409', 'term': 'Mastectomy, Radical'}, {'id': 'D008408', 'term': 'Mastectomy'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D059035', 'term': 'Perioperative Period'}, {'id': 'D005791', 'term': 'Patient Care'}, {'id': 'D006296', 'term': 'Health Services'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D013267', 'term': 'Stilbenes'}, {'id': 'D001597', 'term': 'Benzylidene Compounds'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 600}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2011-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-05', 'completionDateStruct': {'date': '2021-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-05-23', 'studyFirstSubmitDate': '2011-12-29', 'studyFirstSubmitQcDate': '2012-01-03', 'lastUpdatePostDateStruct': {'date': '2016-05-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-01-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Progression-free survival of patients.', 'timeFrame': 'within 10 years after diagnosis'}, {'measure': 'Overall survival of the patients', 'timeFrame': 'within 10 years after diagnosis'}], 'secondaryOutcomes': [{'measure': 'The pathological remission rate of patients after neoadjuvant chemotherapy.', 'timeFrame': 'within 80 days after diagnosis (after 4 cycles of neoadjuvant chemotherapy)'}, {'measure': 'The clinical remission rate of patients after neoadjuvant chemotherapy', 'timeFrame': 'within 80 days after diagnosis (after 4 cycles of neoadjuvant chemotherapy)'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['breast cancer', 'neoadjuvant chemotherapy', 'amenorrhea'], 'conditions': ['Breast Cancer Nos Premenopausal']}, 'descriptionModule': {'briefSummary': 'The current study is a multicentre, randomized, open (unblended), prospective clinical trial which is sponsored by the researchers. The trial is designed to compare the effectiveness between docetaxel plus epirubicin, and docetaxel plus epirubicin plus cyclophosphamide as neoadjuvant chemotherapy for operable premenopausal breast cancer patients, and also to compare the outcomes associated with chemo-induced amenorrhea between the two neoadjuvant chemotherapies. The investigators will randomly assign 600 premenopausal female patients with operable breast cancer to receive four cycles of docetaxel and epirubicin (TE); or four cycles of docetaxel, epirubicin, and cyclophosphamide (TEC). After every two cycles of neoadjuvant chemotherapy, the investigators will estimate the effectiveness of therapy. Patients will undergo modified radical mastectomy or breast-conserving surgery after four cycles of neoadjuvant chemotherapy, and then receive postoperative chemotherapy (two cycles), radiation therapy, herceptin targeted therapy or hormone therapy according to the NCCN (2011) guideline. The follow-up will be ten years after surgeries. The primary aim is to examine whether the docetaxel and epirubicin (TE) will be as effective as the docetaxel, epirubicin, and cyclophosphamide (TEC) (pCR rate, cCR rate, PR rate, SD rate, progression-free survival (PFS) and overall survival (OS)). The secondary aim is to correlate chemo (TE/TEC)-induced amenorrhea with outcomes in premenopausal women.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. The patients signed the written informed consent.\n2. The patients present with operable breast cancers that were diagnosed by histopathology and have no distant metastasis.\n3. The patients have no history of anti-cancer therapies including chemotherapy, radiation therapy, hormone therapy and surgical therapy.\n4. The patients have normal cardiac functions by echocardiography.\n5. The patients' ECOG scores are ≤ 0-2.\n6. The age of patient is ≥ 18 years old; And the patients are premenopausal females.\n7. The patients are disposed to practice contraception during the whole trial.\n8. The results of patients' blood tests are as follows:\n\n * Hb ≥ 90 g/L\n * WBC ≥ 4.0×109/L\n * Plt ≥ 100×109/L\n * Neutrophils ≥ 1.5×109/L\n * ALT and AST ≤ triple of normal upper limit.\n * TBIL ≤ 1.5 times of normal upper limit.\n * Creatinine ≤ 1.25 times of normal upper limit.\n\nExclusion Criteria:\n\n1. The patients have other cancers at the same time or have the history of other cancers in recent five years, excluding the controlled skin basal cell carcinoma or skin squamous cell carcinoma or carcinoma in situ of cervix.\n2. The patients have active infections that were not suitable for chemotherapy.\n3. The patients have severe non-cancerous diseases.\n4. The patients are undergoing current administration of anti-cancer therapies, or are attending some other clinical trails.\n5. The patients whose breast cancers are HER2 positive and choose to undergo the neoadjuvant chemotherapy that includes herceptin regimen.\n6. The patients are pregnant or lactational, or they refuse to practice contraception during the whole trial.\n7. The patients are in some special conditions that they can't understand the written informed consent, such as they are demented or hawkish.\n8. The patients have allergic history of the chemotherapeutic agents.\n9. The patients have bilateral breast cancers."}, 'identificationModule': {'nctId': 'NCT01503905', 'briefTitle': 'Neoadjuvant Chemotherapy for Operable Premenopausal Breast Cancer Patients', 'organization': {'class': 'OTHER', 'fullName': 'Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University'}, 'officialTitle': 'Comparison of the Effectiveness of Neoadjuvant Chemotherapy and the Outcomes Associated With Chemo-induced Amenorrhea Between Docetaxel Plus Epirubicin, and Docetaxel Plus Epirubicin Plus Cyclophosphamide as Neoadjuvant Chemotherapy for Operable Premenopausal Breast Cancer Patients.', 'orgStudyIdInfo': {'id': 'BCSCO001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Docetaxel plus epirubicin', 'interventionNames': ['Drug: Docetaxel', 'Drug: epirubicin', 'Procedure: Modified radical mastectomy or breast-conserving Surgery', 'Drug: Docetaxel (post-operative)', 'Drug: Epirubicin (post-operative)', 'Radiation: Radiation therapy', 'Drug: Herceptin （post-operative)', 'Drug: Tamoxifen (post-operative)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'docetaxel plus epirubicin plus cyclophosphamide', 'interventionNames': ['Drug: Docetaxel', 'Drug: epirubicin', 'Drug: cyclophosphamide', 'Procedure: Modified radical mastectomy or breast-conserving Surgery', 'Drug: Docetaxel (post-operative)', 'Drug: Epirubicin (post-operative)', 'Drug: Cyclophosphamide (post-operative)', 'Radiation: Radiation therapy', 'Drug: Herceptin （post-operative)', 'Drug: Tamoxifen (post-operative)']}], 'interventions': [{'name': 'Docetaxel', 'type': 'DRUG', 'description': '75mg/m2, iv injection, day1, every 21 days', 'armGroupLabels': ['Docetaxel plus epirubicin', 'docetaxel plus epirubicin plus cyclophosphamide']}, {'name': 'epirubicin', 'type': 'DRUG', 'description': '80mg/ m2, iv injection, day1, every 21 days', 'armGroupLabels': ['Docetaxel plus epirubicin', 'docetaxel plus epirubicin plus cyclophosphamide']}, {'name': 'cyclophosphamide', 'type': 'DRUG', 'description': '500 mg/m2, iv injection, day1, every 21 days', 'armGroupLabels': ['docetaxel plus epirubicin plus cyclophosphamide']}, {'name': 'Modified radical mastectomy or breast-conserving Surgery', 'type': 'PROCEDURE', 'description': 'Two weeks after four cycles of neoadjuvant chemotherapy', 'armGroupLabels': ['Docetaxel plus epirubicin', 'docetaxel plus epirubicin plus cyclophosphamide']}, {'name': 'Docetaxel (post-operative)', 'type': 'DRUG', 'description': 'Two weeks after surgery,75mg/m2, iv injection, day1, every 21 days, 4 cycles totally.', 'armGroupLabels': ['Docetaxel plus epirubicin', 'docetaxel plus epirubicin plus cyclophosphamide']}, {'name': 'Epirubicin (post-operative)', 'type': 'DRUG', 'description': 'Two weeks after surgery, 80mg/m2,iv injection, day1, every 21 days, 4 cycles totally', 'armGroupLabels': ['Docetaxel plus epirubicin', 'docetaxel plus epirubicin plus cyclophosphamide']}, {'name': 'Cyclophosphamide (post-operative)', 'type': 'DRUG', 'description': 'Two weeks after surgery, 500mg/m2, iv injection, day1, every 21 days, 4 cycles totally.', 'armGroupLabels': ['docetaxel plus epirubicin plus cyclophosphamide']}, {'name': 'Radiation therapy', 'type': 'RADIATION', 'description': 'Two weeks after post-operative chemotherapy, perform radiation therapy based on 2011 NCCN guideline.', 'armGroupLabels': ['Docetaxel plus epirubicin', 'docetaxel plus epirubicin plus cyclophosphamide']}, {'name': 'Herceptin （post-operative)', 'type': 'DRUG', 'description': 'Perform herceptin therapy (one year) based on 2011 NCCN guideline if the pathological test of the operative tumor sample showed HER2 positive.', 'armGroupLabels': ['Docetaxel plus epirubicin', 'docetaxel plus epirubicin plus cyclophosphamide']}, {'name': 'Tamoxifen (post-operative)', 'type': 'DRUG', 'description': 'After radiation therapy, totally five years. Perform hormone therapy based on 2011 NCCN guideline if the tumor is ER/PR positive.', 'armGroupLabels': ['Docetaxel plus epirubicin', 'docetaxel plus epirubicin plus cyclophosphamide']}]}, 'contactsLocationsModule': {'locations': [{'zip': '528000', 'city': 'Foshan', 'state': 'Guangdong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Jie Yang', 'role': 'CONTACT', 'phone': '86-13902805191'}], 'facility': "The first People's Hospital of Foshan", 'geoPoint': {'lat': 23.02677, 'lon': 113.13148}}, {'zip': '510010', 'city': 'Guangzhou', 'state': 'Guangdong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Antai Zhang', 'role': 'CONTACT', 'phone': '86-13925115929'}], 'facility': 'Guangdong Women and Children Hospital', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}, {'zip': '510010', 'city': 'Guangzhou', 'state': 'Guangdong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Chenfang Zhang', 'role': 'CONTACT', 'phone': '86-13889908978'}], 'facility': 'Guangzhou Army General Hospital', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}, {'zip': '510060', 'city': 'Guangzhou', 'state': 'Guangdong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Siyu Wang', 'role': 'CONTACT', 'phone': '86-18688464714'}], 'facility': 'Sun Yat-Sen University Cancer Center', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}, {'zip': '510080', 'city': 'Guangzhou', 'state': 'Guangdong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Zhuanghong Wu', 'role': 'CONTACT', 'phone': '86-13602722502'}], 'facility': 'The First Affiliated Hospital of Sun Yat-Sen University', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}, {'zip': '510095', 'city': 'Guangzhou', 'state': 'Guangdong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Hongsheng Li', 'role': 'CONTACT', 'phone': '86-13725111258'}], 'facility': 'Tumor Hospital of Guangzhou', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}, {'zip': '510100', 'city': 'Guangzhou', 'state': 'Guangdong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Pengxi Liu', 'role': 'CONTACT', 'phone': '86-13560333752'}], 'facility': 'The Second Affiliated Hospital of Guangzhou University of Traditional Chinese Medicine', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}, {'zip': '510120', 'city': 'Guangzhou', 'state': 'Guangdong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Fengxi Su', 'role': 'CONTACT', 'email': 'fengxisu@vip.163.com'}], 'facility': 'Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}, {'zip': '510180', 'city': 'Guangzhou', 'state': 'Guangdong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Hongmin Ma', 'role': 'CONTACT', 'phone': '86-13922723808'}], 'facility': 'Guangzhou Women and Children Hospital', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}, {'zip': '510180', 'city': 'Guangzhou', 'state': 'Guangdong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Li Zhao', 'role': 'CONTACT', 'email': 'gdzhaoli@163.com'}], 'facility': "The first People's Hospital of Guangzhou", 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}, {'zip': '510260', 'city': 'Guangzhou', 'state': 'Guangdong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Lehong Zhang', 'role': 'CONTACT', 'phone': '86-13719150959'}], 'facility': 'The Second Affiliated Hospital of Guangzhou Medical University', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}, {'zip': '510282', 'city': 'Guangzhou', 'state': 'Guangdong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Aiguo Wu', 'role': 'CONTACT', 'email': 'wagtyz@sina.com'}], 'facility': 'Zhujiang Hospital of Nanfang Medical University', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}, {'zip': '510515', 'city': 'Guangzhou', 'state': 'Guangdong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Changsheng Ye', 'role': 'CONTACT', 'phone': '86-13802954097'}], 'facility': 'Nanfang Hospital of Nanfang Medical University', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}, {'zip': '510630', 'city': 'Guangzhou', 'state': 'Guangdong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Ningxia Wang', 'role': 'CONTACT', 'email': 'Twnx@Jnu.edu.cn'}], 'facility': 'The First Affiliated Hospital of Jinan University', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}, {'zip': '510630', 'city': 'Guangzhou', 'state': 'Guangdong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Renbin Liu', 'role': 'CONTACT', 'phone': '86-13570073298'}], 'facility': 'The Third Affiliated Hospital of Sun Yat-Sen University', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}, {'zip': '518020', 'city': 'Shenzhen', 'state': 'Guangdong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Dongxian Zhou', 'role': 'CONTACT', 'phone': '86-13510363636'}], 'facility': "Shenzhen People's Hospital", 'geoPoint': {'lat': 22.54554, 'lon': 114.0683}}, {'zip': '518035', 'city': 'Shenzhen', 'state': 'Guangdong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Xianming Wang', 'role': 'CONTACT', 'phone': '86-13500056238'}], 'facility': 'The first Affiliated Hospital of Shenzhen University', 'geoPoint': {'lat': 22.54554, 'lon': 114.0683}}], 'centralContacts': [{'name': 'Fengxi Su, M.D.', 'role': 'CONTACT', 'email': 'fengxisu@vip.163.com', 'phone': '86-20-34071156'}], 'overallOfficials': [{'name': 'Fengxi Su, M.D.', 'role': 'STUDY_CHAIR', 'affiliation': 'Sun Yat-Sen Memerial Hospital of Sun Yat-Sen University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director of Department of Breast Tumor Centre', 'investigatorFullName': 'Fengxi Su', 'investigatorAffiliation': 'Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University'}}}}