Ignite Creation Date:
2025-12-25 @ 3:09 AM
Ignite Modification Date:
2025-12-31 @ 12:46 AM
Study NCT ID:
NCT01710605
Status:
UNKNOWN
Last Update Posted:
2018-04-09
First Post:
2012-08-10
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Medico-economic Interest of Taking Into Account Circulating Tumor Cells (CTC) to Determine the Kind of First Line Treatment for Metastatic, Hormone-receptors Positive, Breast Cancers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009360', 'term': 'Neoplastic Cells, Circulating'}, {'id': 'D001943', 'term': 'Breast Neoplasms'}], 'ancestors': [{'id': 'D009362', 'term': 'Neoplasm Metastasis'}, {'id': 'D009385', 'term': 'Neoplastic Processes'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D001941', 'term': 'Breast Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 800}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2012-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-04', 'completionDateStruct': {'date': '2018-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-04-06', 'studyFirstSubmitDate': '2012-08-10', 'studyFirstSubmitQcDate': '2012-10-18', 'lastUpdatePostDateStruct': {'date': '2018-04-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2012-10-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Progression free survival evaluation', 'timeFrame': '2 years', 'description': 'According to RECIST 1.1 criteria'}, {'measure': 'Economic evaluation', 'timeFrame': '2 years', 'description': 'Economic impact of the strategy will be evaluated (standard treatment choice vs CTC based treatment choice)'}], 'secondaryOutcomes': [{'measure': 'Assessing patient quality of life', 'timeFrame': '2 years', 'description': 'QLQC30 and BR23 individual questionaries'}, {'measure': 'Evaluation of treatment safety according to NCI-CTCAEv4.03', 'timeFrame': '2 years', 'description': 'Evaluation of both chemotherapy and hormone therapy will be recorded in CRFs whatever the randomization.'}, {'measure': 'Overall survival evaluation', 'timeFrame': '2 years'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Circulating tumor cells', 'Breast Cancer', 'Hormone-receptors positive'], 'conditions': ['Ductal Infiltrating Metastatic Breast Cancer', 'Hormone-receptors Positive Breast Cancer']}, 'referencesModule': {'references': [{'pmid': '37931185', 'type': 'DERIVED', 'citation': 'Bidard FC, Kiavue N, Jacot W, Bachelot T, Dureau S, Bourgeois H, Goncalves A, Brain E, Ladoire S, Dalenc F, Gligorov J, Teixeira L, Emile G, Ferrero JM, Loirat D, Cabel L, Kadi A, Dieras V, Alix-Panabieres C, Pierga JY. Overall Survival With Circulating Tumor Cell Count-Driven Choice of Therapy in Advanced Breast Cancer: A Randomized Trial. J Clin Oncol. 2024 Feb 1;42(4):383-389. doi: 10.1200/JCO.23.00456. Epub 2023 Nov 6.'}, {'pmid': '33151266', 'type': 'DERIVED', 'citation': 'Bidard FC, Jacot W, Kiavue N, Dureau S, Kadi A, Brain E, Bachelot T, Bourgeois H, Goncalves A, Ladoire S, Naman H, Dalenc F, Gligorov J, Espie M, Emile G, Ferrero JM, Loirat D, Frank S, Cabel L, Dieras V, Cayrefourcq L, Simondi C, Berger F, Alix-Panabieres C, Pierga JY. Efficacy of Circulating Tumor Cell Count-Driven vs Clinician-Driven First-line Therapy Choice in Hormone Receptor-Positive, ERBB2-Negative Metastatic Breast Cancer: The STIC CTC Randomized Clinical Trial. JAMA Oncol. 2021 Jan 1;7(1):34-41. doi: 10.1001/jamaoncol.2020.5660.'}]}, 'descriptionModule': {'briefSummary': 'The STIC CTC study is a randomized trial to evaluate the medico-economic interest of taking into account circulating tumor cells (CTC) to determine the kind of first line treatment for metastatic, hormone-receptors positive, breast cancers. In the standard arm, the kind of treatment will be decided by clinicians, taking into account the criteria usually used in this setting. In the CTC arm, the type of treatment will be decided by CTC count: hormone-therapy if \\<5CTC/7.5mll (CellSearch technique) or chemotherapy if =5. The main medical objective is to demonstrate the non-inferiority of the CTC-based strategy for the progression-free survival: 994 patients are needed, and will be accrued in French cancer centers. Secondary clinical objectives are to compare toxicity, quality of life and overall survival between the two arms. The medico-economic study will compare cost per progression-free life years gained of the two strategies. The financial impact of centralized (one platform) vs decentralized (several platforms) CTC testing will be evaluated.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Women with metastatic ductal adenocarcinoma breast cancer\n* 18 years old or more\n* Hormone receptors positive breast cancer (ER+ and/or PR+) on the last pathological analysis available.\n* Acceptable patient's clinical situation compatible with chemotherapy or hormonotherapy administration\n* PS \\<4\n* Life expectancy \\> 3 months\n* Evidence of measurable or evaluable disease (RECIST 1.1 criteria)in the 28 days before selection\n* Information of the patient and signature of the informed consent form\n\nExclusion Criteria:\n\n* Patient treated by chemotherapy or hormonotherapy for their metastatic disease (treatment failure under adjuvant hormonotherapy are accepted)\n* Her2 positive breast cancer\n* History of other stage II or III cancer in the 5 years. History of other metastatic cancer (whatever the time between the two cancers).\n* Persons deprived of their freedom or under guardianship.\n* Women unable to comply with the medical follow-up of the study for geographical, social or mental reasons."}, 'identificationModule': {'nctId': 'NCT01710605', 'briefTitle': 'Medico-economic Interest of Taking Into Account Circulating Tumor Cells (CTC) to Determine the Kind of First Line Treatment for Metastatic, Hormone-receptors Positive, Breast Cancers', 'organization': {'class': 'OTHER', 'fullName': 'Institut Curie'}, 'officialTitle': 'Randomized Trial to Evaluate the Medico-economic Interest of Taking Into Account Circulating Tumor Cells (CTC) to Determine the Kind of First Line Treatment for Metastatic, Hormone-receptors Positive, Breast Cancers.', 'orgStudyIdInfo': {'id': 'IC 2011-09'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Standard', 'description': 'Treatment choices (hormonotherapy or chemotherapy) are done according to standard of each center based on clinical, radiological and biological information.', 'interventionNames': ['Biological: Circulating tumor cells counting at baseline']}, {'type': 'EXPERIMENTAL', 'label': 'Circulating Tumor Cells', 'description': 'Treatment choices (hormonotherapy or chemotherapy) are done according to the number of CTC / 7.5 ml of blood at baseline :\n\nIf \\<5 CTC : Hormonotherapy If 5 or more CTC : chemotherapy', 'interventionNames': ['Biological: Circulating tumor cells counting at baseline']}], 'interventions': [{'name': 'Circulating tumor cells counting at baseline', 'type': 'BIOLOGICAL', 'description': '20 ml blood sample collected before randomization', 'armGroupLabels': ['Circulating Tumor Cells', 'Standard']}]}, 'contactsLocationsModule': {'locations': [{'zip': '14076', 'city': 'Caen', 'country': 'France', 'facility': 'Centre François Baclesse', 'geoPoint': {'lat': 49.18585, 'lon': -0.35912}}, {'zip': '21079', 'city': 'Dijon', 'country': 'France', 'facility': 'Centre Georges Francois Leclerc', 'geoPoint': {'lat': 47.31344, 'lon': 5.01391}}, {'zip': '72000', 'city': 'Le Mans', 'country': 'France', 'facility': 'Clinique Victor Hugo', 'geoPoint': {'lat': 48.0021, 'lon': 0.20251}}, {'zip': '69373', 'city': 'Lyon', 'country': 'France', 'facility': 'Centre Leon Berard', 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}, {'zip': '13009', 'city': 'Marseille', 'country': 'France', 'facility': 'Institut Paoli Calmettes', 'geoPoint': {'lat': 43.29695, 'lon': 5.38107}}, {'zip': '34000', 'city': 'Montpellier', 'country': 'France', 'facility': 'Chu Montpellier', 'geoPoint': {'lat': 43.61093, 'lon': 3.87635}}, {'zip': '34298', 'city': 'Montpellier', 'country': 'France', 'facility': 'Institut régional du Cancer de Montpellier', 'geoPoint': {'lat': 43.61093, 'lon': 3.87635}}, {'zip': '06250', 'city': 'Mougins', 'country': 'France', 'facility': 'Centre Azureen de Cancerologie', 'geoPoint': {'lat': 43.60068, 'lon': 6.99523}}, {'zip': '06189', 'city': 'Nice', 'country': 'France', 'facility': 'Centre Antoine Lacassagne', 'geoPoint': {'lat': 43.70313, 'lon': 7.26608}}, {'zip': '75005', 'city': 'Paris', 'country': 'France', 'facility': 'Institut Curie', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '75010', 'city': 'Paris', 'country': 'France', 'facility': 'Hopital SAINT-LOUIS', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '75015', 'city': 'Paris', 'country': 'France', 'facility': 'Hopital Europeen Georges Pompidou', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '75020', 'city': 'Paris', 'country': 'France', 'facility': 'Hopital Tenon', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '92210', 'city': 'Saint-Cloud', 'country': 'France', 'facility': 'Institut Curie - Hopital Rene Huguenin', 'geoPoint': {'lat': 48.84598, 'lon': 2.20289}}, {'zip': '44805', 'city': 'Saint-Herblain', 'country': 'France', 'facility': "Institut de Cancerologie de L'Ouest - Rene Gauducheau", 'geoPoint': {'lat': 47.21154, 'lon': -1.651}}, {'zip': '31052', 'city': 'Toulouse', 'country': 'France', 'facility': 'Institut Claudius Regaud', 'geoPoint': {'lat': 43.60426, 'lon': 1.44367}}, {'zip': '54500', 'city': 'Vandœuvre-lès-Nancy', 'country': 'France', 'facility': 'Centre Alexis Vautrin', 'geoPoint': {'lat': 48.66115, 'lon': 6.17114}}], 'overallOfficials': [{'name': 'Jean-Yves Pierga', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Institut Curie'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Institut Curie', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}