Ignite Creation Date:
2025-12-25 @ 5:03 AM
Ignite Modification Date:
2026-03-05 @ 11:31 AM
Study NCT ID:
NCT03847818
Status:
UNKNOWN
Last Update Posted:
2019-03-01
First Post:
2019-02-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Neoadjuvant Study of Pyrotinib and Trastuzumab Plus Chemotherapy in Patients With HER2 Positive Breast Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Pyrotinib (400mg orally daily)+Trastuzumab (8mg/kg iv load followed by 6mg/kg iv 3-weekly)+Docetaxel (75mg/m2)+ Carboplatin(AUC=5/6), for a total of 4 cycles.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 268}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2019-03-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-02', 'completionDateStruct': {'date': '2021-02-28', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-02-28', 'studyFirstSubmitDate': '2019-02-19', 'studyFirstSubmitQcDate': '2019-02-19', 'lastUpdatePostDateStruct': {'date': '2019-03-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-02-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-03-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participants With Pathological Complete Response (pCR)', 'timeFrame': 'through study completion, an average of 1 year'}], 'secondaryOutcomes': [{'measure': 'Event-free survival', 'timeFrame': 'Following surgery until Year 3'}, {'measure': 'Disease-free Survival', 'timeFrame': 'Following surgery until Year 3'}, {'measure': 'Distance Disease-free Survival', 'timeFrame': 'Following surgery until Year 3'}, {'measure': 'Objective Response Rate', 'timeFrame': 'Baseline up to cycle 4 (assessed at Baseline, at the time of pre-surgery) up to approximately 12 months'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['HER2-positive Breast Cancer']}, 'descriptionModule': {'briefSummary': 'This is a prospective, open-label,multicenter Phase II study for evaluating the efficacy and safety of neoadjuvant pyrotinib and trastuzumab plus chemotherapy as neoadjuvant treatment in HER2 positive early stage or locally advanced breast cancer.', 'detailedDescription': 'The investigators hypothesized that the experimental group (Pyrotinib+Trastuzumab+Docetaxel+ Carboplatin) could have a higher Pathological Complete Response (pCR) rate than the control group (Trastuzumab+Docetaxel+ Carboplatin) in neoadjuvant chemotherapy.\n\nIt is proposed that 268 participants will be enrolled in this study. The target population is women with early breast cancer (stage of T2-3N0-3M0) who are eligible for primary systemic therapy.\n\nThe primary objective of the trial is to determine the pCR rate. The secondary objective of the trial is to determine the Event-free survival(EFS), Disease-free Survival (DFS), Distance Disease-free Survival (DDFS), Objective Response Rate (ORR) rate.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. female patients, 18 years ≤ age ≤75 years；\n2. Performance Status- Eastern Cooperative Oncology Group (ECOG) 0-1;\n3. Histologically confirmed invasive breast cancer（early stage or locally advanced）\n4. HER2 positive (HER2+++ by IHC or FISH+)\n5. Known hormone receptor status.\n6. Cardiovascular: Baseline left ventricular ejection fraction (LVEF)≥55% measured by ECHO\n7. Signed informed consent form (ICF)\n\nExclusion Criteria:\n\n1. Metastatic disease (Stage IV) or inflammatory breast cancer.\n2. Previous or current history of malignant neoplasms, except for curatively treated: Basal and squamous cell carcinoma of the skin, Carcinoma in situ of the cervix.\n3. Clinically relevant cardiovascular disease: Known history of uncontrolled or symptomatic angina, clinically significant arrhythmias, congestive heart failure, transmural myocardial infarction, uncontrolled hypertension ≥180/110);\n4. Unable or unwilling to swallow tablets.'}, 'identificationModule': {'nctId': 'NCT03847818', 'briefTitle': 'Neoadjuvant Study of Pyrotinib and Trastuzumab Plus Chemotherapy in Patients With HER2 Positive Breast Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Shandong University'}, 'officialTitle': 'A Prospective, Open-label,Multicenter Phase II Study of Neoadjuvant Pyrotinib Plus Trastuzumab and Chemotherapy in Women With HER2 Positive Early Stage or Locally Advanced Breast Cancer', 'orgStudyIdInfo': {'id': '495573096'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Pyrotinib+Trastuzumab+Docetaxel+Carboplatin', 'interventionNames': ['Drug: Pyrotinib+Trastuzumab+Docetaxel+Carboplatin']}], 'interventions': [{'name': 'Pyrotinib+Trastuzumab+Docetaxel+Carboplatin', 'type': 'DRUG', 'description': 'Drug: Pyrotinib Pyrotinib: 400mg orally daily\n\nDrug: Trastuzumab Trastuzumab:8mg/kg iv load followed by 6mg/kg iv 3-weekly for a total of 6 cycles;\n\nDrug: Docetaxel Docetaxel: 75mg/m2 for a total of 6 cycles\n\nDrug: Carboplatin Carboplatin: AUC=5 or 6 for a total of 6 cycles', 'armGroupLabels': ['Pyrotinib+Trastuzumab+Docetaxel+Carboplatin']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Yu Zhigang, DR.', 'role': 'CONTACT', 'email': 'yzg@medmail.com.cn', 'phone': '+86 13864182636'}], 'overallOfficials': [{'name': 'Yu Zhigang, DR.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The Second Hospital of Shandong University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shandong University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director', 'investigatorFullName': 'Yu-Zhi Gang', 'investigatorAffiliation': 'The Second Hospital of Shandong University'}}}}