Ignite Creation Date:
2025-12-26 @ 10:58 AM
Ignite Modification Date:
2025-12-31 @ 10:49 PM
Study NCT ID:
NCT05232006
Status:
NOT_YET_RECRUITING
Last Update Posted:
2022-03-08
First Post:
2022-01-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
PARP-inhibitor on Advanced Metastatic Breast Cancer in Germline PALB2 Mutations Carriers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C545685', 'term': 'niraparib'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Two-stage optimal Simon design'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 12}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2022-05', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-01', 'completionDateStruct': {'date': '2030-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-02-21', 'studyFirstSubmitDate': '2022-01-28', 'studyFirstSubmitQcDate': '2022-01-28', 'lastUpdatePostDateStruct': {'date': '2022-03-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-02-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Objective response rate', 'timeFrame': '4 months', 'description': 'Complete or partial tumour response according to RECIST 1.1 criteria accounting for objective response rate in solid tumours at 4 cycles., based on the CT-Scan'}], 'secondaryOutcomes': [{'measure': 'Progression-free survival', 'timeFrame': '12 months', 'description': 'Time from inclusion to progression or death (all-cause) or last follow-up whichever occurs first'}, {'measure': 'Overall survival', 'timeFrame': '12 months', 'description': 'Time from inclusion to death (all-cause) or last follow-up whichever occurs first'}, {'measure': 'Tumoral response', 'timeFrame': '12 months', 'description': 'Partial Response or Complete Response or Stable Disease, as per to RECIST 1.1 criteria for tumoral response, based on CT-Scan'}, {'measure': 'Duration of response', 'timeFrame': '12 months', 'description': 'Time to treatment failure, defined as time between inclusion and treatment discontinuation (any reason: death, disease progression, toxicity) or last follow-up'}, {'measure': 'Adverse event rate', 'timeFrame': '72 months', 'description': 'Adverse events (clinical and biological) between inclusion and 72 months'}, {'measure': 'Quality of Life variation', 'timeFrame': '12 months', 'description': 'European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life C30 Questionnaire, evaluated every 3 months, from inclusion to 12 month'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Metastatic Breast Cancer in Germline-PALB2 Mutations Carriers']}, 'descriptionModule': {'briefSummary': 'The study aims at exploring the potential benefit of a PARP-inhibitor, Niraparib, in metastatic breast cancer developing in germline-PALB2 mutations carriers. This study is designed as a multicentre one-arm two-stage phase 2 clinical trial'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult patients over 18 years\n* PALB2 germline heterozygous mutation carrier, wild type BRCA1\\&2 (breast cancer 1\\&2) affected with metastatic breast cancer in first metastatic treatment line or beyond\n* Histologically or cytologically confirmed breast cancer with evidence of metastatic disease.\n* Triple Negative breast cancer; Patients affected with triple negative cancers should have received anthracyclines and taxanes in neo/adjuvant therapy.\n* Or patients with Hormonal receptor positive (HR+)/ Human epidermal growth factor receptor 2 negative (HER2-) breast cancer, with treatment failure after a second line of therapy; Estrogen Receptor/ProgesteroneReceptor breast cancer positive patients must have received and progressed on currently recommended therapies in this indication (endocrine therapy, CDK4/6 inhibitors (adjuvant or metastatic)), or have a disease form that the treating physician believes to be inappropriate for recommended therapies in this indication.\n* Prior therapy with an anthracycline and a taxane in an adjuvant setting.\n* Prior platinum allowed as long as no breast cancer progression occurred on treatment or if given in adjuvant/neoadjuvant setting, at least 12 months elapsed from last dose to study entry.\n* Eastern Cooperative Oncology Group (ECOG) performance status 0-2.\n* Adequate bone marrow, kidney and liver function.\n* Patients without visceral crisis\n\nExclusion Criteria:\n\n* Patients with HER2 positive disease.\n* Untreated and/or uncontrolled brain metastases.\n* Patients in visceral crisis requiring chemotherapy\n* Cytopenia, defined with the following thresholds: (i) Neutrophil count \\< 1500/mm3; Platelet count\\< 100 000/mm3; Hemoglobin \\<9g/dL\n* Prior malignancy unless curatively treated and disease-free for \\> 5 years prior to study entry. Prior adequately treated non-melanoma skin cancer, in situ cancer of the cervix, ductal carcinoma in situ (DCIS) or stage I grade 1 endometrial cancer allowed.\n* Known HIV (Human Immunodeficiency Virus) infection.\n* Pregnant or breast-feeding women.\n* Lack of affiliation to a social security benefit plan (as a beneficiary or assignee)'}, 'identificationModule': {'nctId': 'NCT05232006', 'acronym': 'PALB2-PARPi-01', 'briefTitle': 'PARP-inhibitor on Advanced Metastatic Breast Cancer in Germline PALB2 Mutations Carriers', 'organization': {'class': 'OTHER', 'fullName': 'Assistance Publique - Hôpitaux de Paris'}, 'officialTitle': 'Phase II Clinical Trial Aiming at Investigating the Effect of a PARP-inhibitor on Advanced Metastatic Breast Cancer in Germline PALB2 Mutations Carriers', 'orgStudyIdInfo': {'id': 'P170929J'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Niraparib', 'description': 'PARP-inhibitor, Niraparib Dosage : starting 300 mg/day for patients with body weight ≥77kg and platelet counts ≥ 150 000/µl or 200 mg when body weight inferior to 77kg and/or platelet counts ≤ 150 000/µl and \\> 100 000/µl Pharmaceutical form : 100 mg capsules Posology : single dose daily Route of administration : oral Administration procedures : oral, daily single dose Duration of treatment : 12 cycles of 28 days each', 'interventionNames': ['Drug: Niraparib']}], 'interventions': [{'name': 'Niraparib', 'type': 'DRUG', 'description': 'Niraparib, once daily', 'armGroupLabels': ['Niraparib']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Odile Cohen Haguenauer, MD PhD', 'role': 'CONTACT', 'email': 'odile.cohen-haguenauer@aphp.fr', 'phone': '+ 33 1 42 49 47 98'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assistance Publique - Hôpitaux de Paris', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}