Ignite Creation Date:
2025-12-25 @ 2:11 AM
Ignite Modification Date:
2025-12-27 @ 7:09 AM
Study NCT ID:
NCT04437160
Status:
RECRUITING
Last Update Posted:
2020-06-18
First Post:
2020-06-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Adjuvant Chemotherapy for Triple Negative Breast Cancer Patients With Residual Disease After Neoadjuvant Chemotherapy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D064726', 'term': 'Triple Negative Breast Neoplasms'}], 'ancestors': [{'id': 'D001943', 'term': 'Breast Neoplasms'}, {'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': 'D015251', 'term': 'Epirubicin'}, {'id': 'C027260', 'term': 'pirarubicin'}, {'id': 'D003520', 'term': 'Cyclophosphamide'}], 'ancestors': [{'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': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 286}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-06', 'completionDateStruct': {'date': '2027-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-06-16', 'studyFirstSubmitDate': '2020-06-05', 'studyFirstSubmitQcDate': '2020-06-16', 'lastUpdatePostDateStruct': {'date': '2020-06-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-06-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'RFS', 'timeFrame': 'median 5 years', 'description': 'RFS defined as the time from randomization to the first recurrence event or death through the end of study'}], 'secondaryOutcomes': [{'measure': 'OS', 'timeFrame': 'median 5 years', 'description': 'OS defined as the time from randomization to all-cause death through the end of study'}, {'measure': 'Percentage of patients with adverse events', 'timeFrame': '2-3 years', 'description': 'To assess the toxicity of adjuvant chemotherapy by CTCAE v5.0'}, {'measure': 'Changes in patient-reported quality of life', 'timeFrame': '2-3 years', 'description': 'To assess the mean changes from baseline score in patient-reported quality of life using EORTC QLQ-C30'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Triple negative breast cancer', 'Neoadjuvant chemotherapy', 'Residual invasive breast cancer', 'Adjuvant chemotherapy'], 'conditions': ['Triple Negative Breast Cancer']}, 'descriptionModule': {'briefSummary': 'This study will evaluate the efficacy and safety of antharcycline-based adjuvant chemotherapy compared with observation in triple negative breast cancer (TNBC) patients with residual invasive disease after platinum and taxanes based neoadjuvant chemotherapy.', 'detailedDescription': 'This study is a multi-center, randomized, phase II study. TNBC patients with residual invasive disease (invasive breast tumor size≥1cm and/or positive axillary lymph nodes) after platinum and taxanes based neoadjuvant chemotherapy are enrolled (n = 286). Patients are assigned to the chemotherapy group or the observation group at a 1:1 ratio randomly 4-6 weeks after surgery. Patients in the chemotherapy group are given anthracycline combined with cyclophosphamide regimen for 4 cycles. At the same time, the blood and tissue samples are collected for relevant tests. Follow up every 3-6 months and record recurrences and deaths.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with histologically confirmed invasive adenocarcinoma of the breast.\n* Triple negative breast cancer: hormone receptor negative (ER \\< 10% and PgR \\< 10%) and HER2 negative (IHC 0/1+ or ISH non-amplified), as defined by the local pathology laboratory.\n* Clinical stage at presentation: T1-4, N0-3, M0, with indications for neoadjuvant chemotherapy.\n* Patient must have received platinum and taxanes neoadjuvant chemotherapy for at least 4 cycles and no tumor progression occurred.\n* Patients should have undergone adequate tumor excision in the breast and lymph nodes after neoadjuvant chemotherapy.\n* Residual invasive disease must be ≥1cm in the breast, and/or have positive axillary lymph nodes observed on pathologic exam after neoadjuvant chemotherapy.\n* ECOG Performance Status: 0-1.\n* Patients without severe heart, lung, liver and kidney disease.\n* Adequate hematologic and end-organ function.\n* No more than 6 weeks may elapse between definitive breast surgery and randomization.\n\nExclusion Criteria:\n\n* Previous neoadjuvant chemotherapy with anthracycline or other drugs (except platinum and taxanes).\n* Previous neoadjuvant chemotherapy with platinum or taxanes alone.\n* Patients have received other adjuvant therapy.\n* Comprehensive medical examinations have revealed distant metastases before randomization.\n* Patients who are not suitable for anthracycline evaluated by investigators.\n* Prior history of other malignancy (except carcinoma in situ).'}, 'identificationModule': {'nctId': 'NCT04437160', 'briefTitle': 'Adjuvant Chemotherapy for Triple Negative Breast Cancer Patients With Residual Disease After Neoadjuvant Chemotherapy', 'organization': {'class': 'UNKNOWN', 'fullName': 'ChineseAMS'}, 'officialTitle': 'A Multicenter, Randomised, Open-label Phase II Study to Evaluate the Efficacy and Safety of Adjuvant Chemotherapy for Triple Negative Breast Cancer Patients With Residual Disease After Platinum-based Neoadjuvant Chemotherapy', 'orgStudyIdInfo': {'id': 'LC2019L06'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Adjuvant chemotherapy', 'description': 'Adjuvant chemotherapy for triple negative breast cancer with residual invasive disease (invasive breast tumor size≥1cm and/or positive axillary lymph nodes) after taxanes and platinum based neoadjuvant chemotherapy.\n\nAdjuvant chemotherapy regiments: Epirubicin 80-90mg/m2 IV or Pirarubicin 50mg/m2 IV + Cyclophosphamide 600mg/m2 IV, q21d\\*4cycles.', 'interventionNames': ['Drug: Epirubicin or Pirarubicin', 'Drug: Cyclophosphamide']}, {'type': 'NO_INTERVENTION', 'label': 'Observation', 'description': 'No adjuvant chemotherapy for triple negative breast cancer with residual invasive disease (invasive breast tumor size≥1cm and/or positive axillary lymph nodes) after taxanes and platinum based neoadjuvant chemotherapy.'}], 'interventions': [{'name': 'Epirubicin or Pirarubicin', 'type': 'DRUG', 'otherNames': ['EPI or THP'], 'description': 'Epirubicin 80-90mg/m2 IV or Pirarubicin 50mg/m2 IV, q21d\\*4cycls', 'armGroupLabels': ['Adjuvant chemotherapy']}, {'name': 'Cyclophosphamide', 'type': 'DRUG', 'otherNames': ['CTX'], 'description': 'Cyclophosphamide 600mg/m2 IV, q21d\\*4cycls', 'armGroupLabels': ['Adjuvant chemotherapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100021', 'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Pin ZHANG, MD', 'role': 'CONTACT', 'email': 'Zhang_pin@sina.com', 'phone': '13701275563'}], 'facility': 'Cancer Hospital & Institute Chinese Academy of Medical Sciences (CAMS)', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': 'Pin ZHANG, MD', 'role': 'CONTACT', 'email': 'Zhang_pin@sina.com', 'phone': '008601-87788120'}], 'overallOfficials': [{'name': 'Pin ZHANG, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Chinese Academy of Medical Sciences'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chinese Academy of Medical Sciences', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical Professor', 'investigatorFullName': 'Pin Zhang', 'investigatorAffiliation': 'Chinese Academy of Medical Sciences'}}}}