Ignite Creation Date:
2025-12-25 @ 12:36 AM
Ignite Modification Date:
2025-12-25 @ 10:45 PM
Study NCT ID:
NCT04297267
Status:
UNKNOWN
Last Update Posted:
2022-07-22
First Post:
2020-03-04
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study to Evaluate Gemcitabine Plus Cisplatin in the Treatment of TNBC Patients Following 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': 'D000093542', 'term': 'Gemcitabine'}, {'id': 'D002945', 'term': 'Cisplatin'}], 'ancestors': [{'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D003841', 'term': 'Deoxycytidine'}, {'id': 'D003562', 'term': 'Cytidine'}, {'id': 'D011741', 'term': 'Pyrimidine Nucleosides'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017672', 'term': 'Nitrogen Compounds'}, {'id': 'D017671', 'term': 'Platinum Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2017-02-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-07', 'completionDateStruct': {'date': '2023-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-07-19', 'studyFirstSubmitDate': '2020-03-04', 'studyFirstSubmitQcDate': '2020-03-04', 'lastUpdatePostDateStruct': {'date': '2022-07-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-03-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Disease free survival', 'timeFrame': '3-year', 'description': 'The length of time after primary treatment for a cancer ends that the patient survives without any signs or symptoms of that cancer'}], 'secondaryOutcomes': [{'measure': 'Recurrence free survival', 'timeFrame': '3-year', 'description': 'Recurrence free survival is calculated from surgery to the first recurrence.'}, {'measure': 'Distant disease free survival', 'timeFrame': '3-year', 'description': 'Distant disease free survival is calculated from surgery to the first distant metastasis.'}, {'measure': 'Overall survival', 'timeFrame': '3-year', 'description': 'Overall survival is calculated from randomization to death from any cause.'}, {'measure': 'Disease free survival(5year)', 'timeFrame': '5-year', 'description': 'The length of time after primary treatment for a cancer ends that the patient survives without any signs or symptoms of that cancer'}, {'measure': 'Recurrence free survival(5year)', 'timeFrame': '5-year', 'description': 'Recurrence free survival(5y) is calculated from surgery to the first recurrence.'}, {'measure': 'Distant disease free survival(5year)', 'timeFrame': '5-year', 'description': 'Distant disease free survival is calculated from surgery to the first distant metastasis.'}, {'measure': 'Overall survival(5year)', 'timeFrame': '5-year', 'description': 'Overall survival is calculated from randomization to death from any cause.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['gemcitabine', 'cisplatin', 'non-pCR', 'TNBC'], 'conditions': ['Triple Negative Breast Cancer']}, 'descriptionModule': {'briefSummary': 'This is a prospective, open-lable phase II clinical trial evaluating the effectiveness and safety of gemcitabine plus cisplatin as adjuvant treatment for non-pCR TNBC patients after standard neoadjuvant chemotherapy.', 'detailedDescription': 'This is a prospective, open-lable phase II clinical trial evaluating the effectiveness and safety of gemcitabine plus cisplatin as adjuvant treatment for non-pCR TNBC patients after standard neoadjuvant chemotherapy. Non-pCR TNBC patients who completed 6-8 cycles of standard neoadjuvant chemotherapy will be included in this study and receive 4 cycles of GP regimen chemotherapy(cisplatin 75 mg/m² d1 and gemcitabine 1250 mg/m² d1,8, every 3 weeks). Our primary endpoint is disease free survival (DFS). Secondary end points include overall survival (OS), recurrence free survival (RFS), distant disease free survival (DDFS)rates and safety.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age between 18 and 70 years old\n* Patients with histologically confirmed unilateral invasive ductal carcinoma(according to WHO histologically type)\n* Tumor clinical staged as IIB-IIIB before neoadjuvant chemotherapy (according to the 7th AJCC edition).\n* After standard treatment (6-8 cycles) of neoadjuvant chemotherapy (plan formulated by the attending doctor, including anthracycline and paclitaxel drugs, must not contain platinum), assessed by the surgery, the original site for non - pCR (MP class 1-4) or lymph nodes are still positive for patients.\n* No gross or microscopic tumor residual after resection.\n* Patients with clear ER/PR/Her2 receptor, and ER/PR/Her2 are all negative(Specific definition: immunohistochemical detection of ER \\< 1% positive tumor cell is defined as the ER negative, PR \\< 1% positive tumor cells is defined as the PR negative, Her2 0-1 or Her2 2 + but after FISH or CISH tested negatie for c (no amplification) is defined as the Her2-negative).\n* No evidence of distant metastasis in the clinical or radiological aspects of preoperative. examination,that is M0.\n* Patients without peripheral neuropathy or I peripheral neurotoxicity.\n* Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≤1.\n* Patients recovered well after surgery, at least 1 weeks after the operation.\n* Adequate marrow: White blood cells count≥3000/μL,neutrophil count ≥1500/μL, hemoglobin ≥9g/dL and platelet count ≥75000/μL.\n* Normal liver function test: Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) ≤ 1.5×upper limit of normal (ULN) concomitant with alkaline phosphatase (ALP) ≤ 2.5×ULN, and bilirubin ≤ 1.5ULN.\n* Adequate renal function: Serum creatinine ≤ 1.5ULN.\n* Contraception during the treatment of child-bearing women.\n* Adequate cardiac function :Left ventricular ejection fraction (LVEF) \\> 50%.\n* Patients must be informed of the investigational nature of this study and give written informed consent.\n* Patients without serious heart, lung, liver, kidney and other important organs disease history.\n* Patients have good compliance.\n\nExclusion Criteria:\n\n* Patients with bilateral breast cancer or carcinoma in situ(DCIS/LCIS).\n* Metastasis of any part except axillary lymph nodes.\n* Clinical or imaging suspicion of the contralateral breast is malignant but not confirmed, requiring biopsy.\n* There have been malignant tumors (except for basal cell carcinoma and carcinoma in situ of cervix) in the last five years, including breast cancer.\n* Patients have been enrolled in other clinical trials.\n* Patients with severe systemic illnesses and/or uncontrolled infections are unable to join the study.\n* Patients with severe cardio-cerebrovascular disorders (e.g., unstable angina pectoris, chronic heart failure, uncontrollable hypertension \\>160/100mmgh, myocardial infarction or cerebrovascular accident) in the first 6 months of randomization.\n* Pregnant lactating women (child-bearing women must be negative for pregnancy test within 14 days prior to first delivery, if positive, the pregnancy should be excluded by ultrasound.)\n* Child-bearing women who are unwilling to take effective contraceptive measures in the course of research.\n* Patients with mental illness, cognitive impairment, inability to understand test protocols and side effects, and those who fail to complete the trial programme and follow-up work (a systematic assessment is required before the trial).\n* Persons without personal freedom and independent civil capacity.'}, 'identificationModule': {'nctId': 'NCT04297267', 'acronym': 'nonpCR GP', 'briefTitle': 'A Study to Evaluate Gemcitabine Plus Cisplatin in the Treatment of TNBC Patients Following Neoadjuvant Chemotherapy', 'organization': {'class': 'OTHER', 'fullName': 'Fudan University'}, 'officialTitle': 'A Prospective, Single Arm, Multicenter, Phase II Trial of Gemcitabine Plus Cisplatin in the Treatment of Patients With Non-pCR Triple Negative Breast Cancer Following Neoadjuvant Chemotherapy', 'orgStudyIdInfo': {'id': '1608162-19-1805B'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'GP group', 'description': 'Patients should receive four cycles of GP regimen (cisplatin at 75 mg/m2 iv infusion on day 1 plus gemcitabine at 1250 mg/m2 iv infusion over 30 min on day 1 and 8 every 3 weeks).', 'interventionNames': ['Drug: Gemcitabine', 'Drug: Cisplatin']}], 'interventions': [{'name': 'Gemcitabine', 'type': 'DRUG', 'description': 'Gemcitabine 1250mg/m2,d1,d8,every 3 weeks', 'armGroupLabels': ['GP group']}, {'name': 'Cisplatin', 'type': 'DRUG', 'description': 'Cisplatin 75mg/m2,d1，every 3 weeks', 'armGroupLabels': ['GP group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '200032', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'country': 'China', 'facility': 'Cancer Hospital/ Institute, Fudan University', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fudan University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Zhimin Shao', 'investigatorAffiliation': 'Fudan University'}}}}