Ignite Creation Date:
2025-12-26 @ 10:17 PM
Ignite Modification Date:
2026-02-05 @ 9:47 PM
Study NCT ID:
NCT06805812
Status:
RECRUITING
Last Update Posted:
2025-02-03
First Post:
2025-01-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Predicting clinicAL outcoMes During First-line CDK4/6 Inhibitors Plus Endocrine Therapy in Patients With Advanced Hormone REceptor-poSitive HER2-negative Breast Cancer: the Retrospective-prospective Multicenter Italian PALMARES-2 Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}, {'id': 'D009362', 'term': 'Neoplasm Metastasis'}, {'id': 'D001941', 'term': 'Breast Diseases'}, {'id': 'D018567', 'term': 'Breast Neoplasms, Male'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D009385', 'term': 'Neoplastic Processes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C500026', 'term': 'palbociclib'}, {'id': 'C000589651', 'term': 'ribociclib'}, {'id': 'C000590451', 'term': 'abemaciclib'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2024-10-31', 'size': 1046186, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2025-01-27T11:55', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Archival tumor FFPE block'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 3500}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2040-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-01-28', 'studyFirstSubmitDate': '2025-01-07', 'studyFirstSubmitQcDate': '2025-01-28', 'lastUpdatePostDateStruct': {'date': '2025-02-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-02-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2030-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall Survival (OS)', 'timeFrame': 'From the first-line treatment start to date of any-cause death or last follow up, up to 120 months'}], 'secondaryOutcomes': [{'measure': 'Real-world Progression-Free Survival (rwPFS)', 'timeFrame': 'From the start of first-line treatment to date of disease progression documented in patient medical charts or death or last follow up, whichever occurs first, up to 120 months'}, {'measure': 'Time To Next Treatment or Death (TTNT-D)', 'timeFrame': 'From the start of first-line treatment to date of subsequent therapy start or death or last follow up, whichever occurs first, up to 120 months'}, {'measure': 'Time To Chemotherapy or Death (TTC-D)', 'timeFrame': 'From the start of first-line treatment to date of first chemotherapy for advanced disease start or death or last follow up, whichever occurs first, up to 120 months'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['HR+/HER2- Advanced Breast Cancer', 'HR+/HER2- Metastatic Breast Cancer', 'Palbociclib', 'Ribociclib', 'Abemaciclib', 'CDK4/6i', 'Cyclin-Dependent Kinase 4/6 inhibitors', 'Metastatic Breast Cancer'], 'conditions': ['Breast Adenocarcinoma', 'Breast Cancer Stage IV', 'Breast Cancer, Metastatic', 'Breast Carcinoma', 'Breast Diseases', 'Breast Neoplasms', 'Breast Neoplasms, Male', 'Breast Cancer', 'Breast Cancer With Metastatic Bone Disease', 'Breast Cancers', 'Breast Neoplasm', 'Breast Tumors', 'HR+ HER2- Men, Pre/Postmenopausal Advanced Breast Cancer', 'HR+ Advanced or Metastatic Breast Cancer', 'HR+/HER2- Breast Cancer', 'HRpos Breast Neoplasms', 'HR-positive, HER2-negative Advanced Breast Cancer', 'HR-positive, HER2-negative and PIK3CA Mutation Advanced Breast Cancer', 'HR-positive Breast Cancer', 'Hormone Receptor-Positive Breast Cancer', 'Hormone Receptor Positive Breast Adenocarcinoma', 'Hormone Receptor Positive Breast Carcinoma', 'Hormone Receptor Positive Breast Neoplasms', 'Hormone Receptor Positive HER-2 Negative Breast Cancer', 'Hormone Receptor Positive Malignant Neoplasm of Breast', 'Hormone Receptor Positive Metastatic Breast Cancer', 'Hormone Receptor Positive, HER2 Negative Breast Cancer', 'Hormone Receptor Negative Breast Cancer', 'Hormone Receptor Positive, HER2-negative, Advanced Breast Cancer', 'Hormone Receptor Positive Breast Cancer', 'Hormone Receptor Positive (ER+/PR+, and Her2-) Metastatic Breast Cancer', 'Hormone Receptor Positive, HER2-negative Neoplasms', 'Hormone Receptor Positive, HER2-low Neoplasms', 'Hormone Receptor Positive (HR+), HER2-negative Breast Cancer', 'Hormone Receptor (HR)-Positive Breast Cancer', 'Hormone Receptor-Positive, HER2-Negative Metastatic Breast Cancer', 'Palbociclib', 'Ribociclib', 'Abemaciclib', 'CDK4/6 Inhibitor', 'CDK4/6 Inhibitors']}, 'descriptionModule': {'briefSummary': 'PALMARES-2 is a retrospective/prospective, observational, multicenter, population-based study, aiming at providing real-world evidences on HR+/HER2- aBC patients treated with first-line CDK4/6i plus ET. The present study has the objective to collect data coming from different sources, i.e. RWD, medical images and biological samples, from patients treated with CDK4/6i as first-line of therapy for HR+/HER2- aBC. In consideration of the complexity of data collected and different objectives of the study, this master protocol foresees different sub-studies, which encompasses different methodologies for data collection, data extraction and analyses.', 'detailedDescription': "The PALMARES-2 study aims to collect data from different sources, i.e. real-world clinical data, medical images and biological data and samples, from patients treated with CDK4/6i as first-line therapy for patients with HR+/HER2- advanced breast cancer. Due to the complexity of the data collected and the different objectives of the study, this protocol includes several sub-studies, which include different methodologies for data collection, extraction and analysis:\n\n* The first sub-study (RWD sub-study) will aim to collect real-world clinical data of patients who received ET+CDK4/6i in the first-line setting; the primary objective of this sub-study is to assess whether there is a difference in OS between the three CDK4/6i in the real-world population, while secondary objectives include comparisons in specific sub-groups;\n* The second sub-study (Safety sub-study) includes the collection of comorbidities, concomitant medications and toxicities of patients enrolled in the study; the primary objective of this sub-study is to evaluate the difference in severe toxicity between the three CDK4/6i in the real-world population\n* The third sub-study (medical imaging sub-study) consists of the collection of computed tomography (CT) and fluorodeoxyglucose positron emission tomography (FdG-PET) images at baseline and digitised haematoxylin-eosin (HE) slides to build a multi-omics predictive model;\n* The fourth sub-study (translational sub-study) aims to collect tumour samples from a proportion of patients enrolled in the study to perform genomics and transcriptomics analyses; information from this data source will be integrated into the model built with the previous data to further improve the performance of the previous model\n* The fifth sub-study (subsequent lines sub-study) focuses on the lines of treatment administered to patients enrolled in the study at the time of progression after first-line treatment with ET+CDK4/6i, with the aim of building predictive models of response to subsequent lines of treatment, capable of supporting oncologists' and patients' decisions in this context."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'The study involves the retrospective and prospective collection of consecutive HR+/HER2- advanced Breast Cancer patients (defined as metastatic or locally advanced not candidate for definitive curative intervention) treated with CDK4/6i in combination with endocrine therapy as first-line treatment for advanced disease in different Italian cancer centers.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of HR+/HER2- advanced Breast Cancer (aBC), as defined as at least 1% estrogen receptor (ER) and/or progesterone receptor (PgR) positivity at IHC. HER2 negativity is defined on the basis of an IHC score of 0, 1+, or 2+ with absence of gene amplification at in situ hybridization (ISH) analyses.\n* Have received or are candidate to receive treatment with palbociclib, ribociclib or abemaciclib in combination with endocrine therapy as first-line treatment for HR+/HER2- aBC.\n\nExclusion Criteria:\n\n* Less than 3 months of follow up from the CDK4/6i start to the date of data cut-off;\n* Have received CDK4/6i as monotherapy;\n* Have received CDK4/6i as adjuvant treatment for localized disease.'}, 'identificationModule': {'nctId': 'NCT06805812', 'acronym': 'PALMARES-2', 'briefTitle': 'Predicting clinicAL outcoMes During First-line CDK4/6 Inhibitors Plus Endocrine Therapy in Patients With Advanced Hormone REceptor-poSitive HER2-negative Breast Cancer: the Retrospective-prospective Multicenter Italian PALMARES-2 Study', 'organization': {'class': 'OTHER', 'fullName': 'Fondazione IRCCS Istituto Nazionale dei Tumori, Milano'}, 'officialTitle': 'Predictive Impact of Peripheral Blood Lymphocytes on clinicAL outcoMes During First-line CDK4/6 Inhibitors Plus Endocrine Therapy in Patients With Advanced Hormone REceptor-poSitive HER2-negative Breast Cancer: the Retrospective-prospective Multicenter Italian PALMARES-2 Study', 'orgStudyIdInfo': {'id': 'INT101/23'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Palbociclib', 'type': 'DRUG', 'description': 'Administered in combination with endocrine therapy'}, {'name': 'Ribociclib', 'type': 'DRUG', 'description': 'Administered in combination with endocrine therapy'}, {'name': 'Abemaciclib', 'type': 'DRUG', 'description': 'Administered in combination with endocrine therapy'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Aviano', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Lorenzo Gerratana', 'role': 'CONTACT', 'email': 'elena.nascimbeni@cro.it', 'phone': '+390434659111'}], 'facility': 'Centro di Riferimento Oncologico IRCCS', 'geoPoint': {'lat': 46.07056, 'lon': 12.59472}}, {'city': 'Brescia', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Rebecca Pedersini', 'role': 'CONTACT', 'email': 'giadamola.gm@gmail.com', 'phone': '+3903039951'}], 'facility': 'Azienda Socio Sanitaria Territoriale degli Spedali Civili', 'geoPoint': {'lat': 45.53558, 'lon': 10.21472}}, {'city': 'Catania', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Paolo Vigneri', 'role': 'CONTACT', 'email': 'domenica.caponnetto@humanitascatania.it', 'phone': '+390957339000'}], 'facility': 'Humanitas Istituto Clinico Catanese', 'geoPoint': {'lat': 37.49223, 'lon': 15.07041}}, {'city': 'Como', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Monica Giordano', 'role': 'CONTACT', 'email': 'gilardonimicol@libero.it', 'phone': '+390315855602'}], 'facility': "ASST Lariana - Ospedale Sant'Anna", 'geoPoint': {'lat': 45.80819, 'lon': 9.0832}}, {'city': 'Cremona', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Daniele Generali', 'role': 'CONTACT', 'email': 'valeria.cervoni@asst-cremona.it', 'phone': '+390372405246'}], 'facility': 'ASST Ospedale Maggiore', 'geoPoint': {'lat': 45.13325, 'lon': 10.02129}}, {'city': 'Florence', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Icro Meattini', 'role': 'CONTACT', 'email': 'carracinom@aou-careggi.toscana.it', 'phone': '+390557947908'}], 'facility': 'Azienda Ospedaliero Universitaria Careggi', 'geoPoint': {'lat': 43.77925, 'lon': 11.24626}}, {'city': 'Genova', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Matteo Lambertini', 'role': 'CONTACT', 'phone': '+390105558912'}], 'facility': 'Ospedale San Martino', 'geoPoint': {'lat': 45.21604, 'lon': 11.87211}}, {'city': 'Meldola', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Marianna Sirico', 'role': 'CONTACT', 'email': 'emanuela.montanari@irst.emr.it', 'phone': '+390543739100'}], 'facility': 'Istituto Tumori della Romagna IRST IRCCS', 'geoPoint': {'lat': 44.12775, 'lon': 12.0626}}, {'city': 'Milan', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Ornella Garrone', 'role': 'CONTACT', 'email': 'eleonora.galbiati@policlinico.mi.it', 'phone': '+390255032783'}], 'facility': "Fondazione IRCCS Ca' Granda Ospedale Maggiore", 'geoPoint': {'lat': 42.78235, 'lon': 12.59836}}, {'city': 'Milan', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Giuseppe Curigliano', 'role': 'CONTACT', 'email': 'datamanagement@ieo.it', 'phone': '+3902574891'}], 'facility': 'IEO Istituto Europeo di Oncologia', 'geoPoint': {'lat': 42.78235, 'lon': 12.59836}}, {'city': 'Milan', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Marta Piras', 'role': 'CONTACT', 'email': 'ctc.trialstartup@hsr.it', 'phone': '+390226437627'}], 'facility': 'IRCCS Ospedale San Raffaele', 'geoPoint': {'lat': 42.78235, 'lon': 12.59836}}, {'city': 'Milan', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Nicla La Verde', 'role': 'CONTACT', 'email': 'onco.datamanager@asst-fbf-sacco.it', 'phone': '+390239041'}], 'facility': 'Ospedale ASST Fatebenefratelli Sacco', 'geoPoint': {'lat': 42.78235, 'lon': 12.59836}}, {'city': 'Mirano', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Donata Sartori', 'role': 'CONTACT', 'email': 'silvia.coccato@aulss3.veneto.it', 'phone': '+390415133483'}], 'facility': 'ULSS 3 Veneto', 'geoPoint': {'lat': 45.49458, 'lon': 12.10775}}, {'city': 'Modena', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Angela Toss', 'role': 'CONTACT', 'email': 'martina.manni@unimore.it', 'phone': '+390594222230'}], 'facility': 'Azienda Ospedaliero-Universitaria', 'geoPoint': {'lat': 44.64783, 'lon': 10.92539}}, {'city': 'Napoli', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Mario Giuliano', 'role': 'CONTACT', 'email': 'studiclinici.oncologia@unina.it', 'phone': '+390817463660'}], 'facility': 'Azienda Ospedaliero-Universitaria Federico II', 'geoPoint': {'lat': 40.87618, 'lon': 14.5195}}, {'city': 'Napoli', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Roberta Caputo', 'role': 'CONTACT', 'email': 'c.ferrara@istitutotumori.na.it', 'phone': '+3908117770133'}], 'facility': 'Istituto Nazionale Tumori IRCCS Fondazione G. 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Federico II, Napoli', 'class': 'UNKNOWN'}, {'name': 'San Raffaele University Hospital, Italy', 'class': 'OTHER'}, {'name': 'Centro di Riferimento Oncologico - Aviano', 'class': 'OTHER'}, {'name': 'Azienda Socio-Sanitaria Territoriale Lariana', 'class': 'UNKNOWN'}, {'name': 'Azienda ULSS 3 Serenissima, Ospedale di Mirano', 'class': 'UNKNOWN'}, {'name': 'Azienda Ospedaliero Universitaria Policlinico Umberto I, Roma', 'class': 'UNKNOWN'}, {'name': 'Fondazione IRCCS Policlinico San Matteo di Pavia', 'class': 'OTHER'}, {'name': 'IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy', 'class': 'OTHER'}, {'name': 'Fondazione Policlinico Universitario Agostino Gemelli IRCCS', 'class': 'OTHER'}, {'name': 'Azienda Ospedaliero-Universitaria Careggi', 'class': 'OTHER'}, {'name': 'Humanitas, Istituto Clinico Catanese', 'class': 'OTHER_GOV'}, {'name': 'Istituto Nazionale Tumori IRCCS - Fondazione G. Pascale', 'class': 'NETWORK'}, {'name': 'Fondazione Policlinico Universitario Campus Bio-Medico', 'class': 'OTHER'}, {'name': "Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico", 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}