Ignite Creation Date:
2025-12-26 @ 11:11 AM
Ignite Modification Date:
2025-12-31 @ 7:30 PM
Study NCT ID:
NCT00210028
Status:
TERMINATED
Last Update Posted:
2006-11-14
First Post:
2005-09-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study Assessing Efficacy of ZARNESTRA™ Combined With Tamoxifen in Patients With Advanced or Metastatic Breast Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}], 'ancestors': [{'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': 'D013629', 'term': 'Tamoxifen'}, {'id': 'C402769', 'term': 'tipifarnib'}], 'ancestors': [{'id': 'D013267', 'term': 'Stilbenes'}, {'id': 'D001597', 'term': 'Benzylidene Compounds'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'count': 40}}, 'statusModule': {'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2003-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2006-11', 'completionDateStruct': {'date': '2008-08'}, 'lastUpdateSubmitDate': '2006-11-10', 'studyFirstSubmitDate': '2005-09-13', 'studyFirstSubmitQcDate': '2005-09-13', 'lastUpdatePostDateStruct': {'date': '2006-11-14', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-09-21', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To evaluate the objective response rate when ZARNESTRA is added to administration of tamoxifen in patients suffering from metastatic or advanced inoperable breast cancer, who are progressing on tamoxifen treatment'}], 'secondaryOutcomes': [{'measure': 'To evaluate the time to progression'}, {'measure': 'To evaluate the clinical benefit (response + stable disease at 6 months)'}, {'measure': 'To evaluate the safety of the combination ZARNESTRA and tamoxifen'}, {'measure': 'To evaluate a possible pharmacokinetic interaction between ZARNESTRA and tamoxifen'}, {'measure': 'To evaluate the biological predictive and prognostic factors of a response'}]}, 'conditionsModule': {'keywords': ['Breast Neoplasms', 'Zarnestra', 'Tamoxifen', 'estrogen receptor', 'progesterone receptor'], 'conditions': ['Breast Neoplasms']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the objective response rate when ZARNESTRA is added to treatment with tamoxifen'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Histologically proven, metastatic or locally advanced inoperable breast cancer\n* Tumor considered potentially hormone-sensitive, i.e. presence by IHC of hormone receptors for estrogens (ER+ for more than 10% of cells) and/or progesterone (Pg+ for more than 10% of cells) or both. This expression may have been detected on the primary tumor or at a metastatic site. The method used will be reassessed by IHC if it involves a radioligand technique whenever it is possible to obtain histological material.\n* Progressing on treatment with tamoxifen, given either as adjuvant treatment or for advanced/metastatic breast cancer. Any previous treatment with a steroidal or nonsteroidal antiaromatase in a neo-adjuvant, adjuvant or metastatic situation is permitted. Likewise, any previous treatment with chemotherapy and/or herceptin in a nonmetastatic situation is permitted.\n* Post-menopausal patients\n* Age \\> 18 years\n* At least one measurable lesion according to the Response Evaluation Criteria for Solid Tumors (RECIST) criteria; for patients who only have bone metastases, an evaluable non-irradiated lytic lesion is required\n* Performance Status (WHO): PS ≤ 2 (Appendix 1).\n* Laboratory tests in accordance with the following criteria:\n\nNeutrophils ≥ 2x109/l,Platelets ≥ 100x109/l,Hemoglobin ≥ 10 g/dl, ASAT, ALAT ≤ 2.5 N , or \\< 5 N when liver metastasis,bilirubin ≤ 1.5 N creatinin ≤ 1.5 N\n\n* Signed, written consent before any study-related procedure\n\nExclusion Criteria:\n\n* Men\n* Pre-menopausal patients who are not receiving concurrent LHRH agonist therapy\n* ER- and PR-negative patients\n* Contraindication to antiestrogens (thromboembolic risk) or ZARNESTRA\n* Non metastatic tumor susceptible to management by radiotherapeutic and/or surgical means\n* T4d inflammatory tumor (PEV 2 or 3).\n* Short-term, life-threatening lesions: hepatic invasion \\> 1/3 of liver volume, pulmonary lymphangitis, uncontrolled cerebral metastases, carcinomatous meningitis\n* Sensory neuropathy \\> or = grade 1 (WHO)\n* Previous history of uncontrolled cancers or controlled for less than 5 years, except basal cell skin cancers and in situ cancers of the cervix.\n* Chronic diseases (somatic or psychiatric) with a poor prognosis\n* subjects with enzyme-inducing anti-convulsants (e.g., phenytoin, phenobarbital, carbamazepine) : this treatment is not permitted while taking ZARNESTRA\n* Patients who, for family, social, geographic or psychological reasons, could not be followed up correctly.'}, 'identificationModule': {'nctId': 'NCT00210028', 'briefTitle': 'Study Assessing Efficacy of ZARNESTRA™ Combined With Tamoxifen in Patients With Advanced or Metastatic Breast Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Institut Claudius Regaud'}, 'officialTitle': 'Open, Single-Arm Phase II Study Assessing Efficacy of ZARNESTRA™ Combined With Tamoxifen in Patients With Advanced or Metastatic Breast Cancer Expressing the Estrogen and/or Progesterone Receptor', 'orgStudyIdInfo': {'id': '03 SEIN 04'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Tamoxifen', 'type': 'DRUG'}, {'name': 'Zarnestra', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Bordeaux', 'country': 'France', 'facility': 'Institut Bergonie', 'geoPoint': {'lat': 44.84124, 'lon': -0.58046}}, {'city': 'Montpellier', 'country': 'France', 'facility': "Institut Val d'Aurelle_ Paul Lamarque", 'geoPoint': {'lat': 43.61093, 'lon': 3.87635}}, {'city': 'Toulouse', 'country': 'France', 'facility': 'Institut Claudius Regaud', 'geoPoint': {'lat': 43.60426, 'lon': 1.44367}}], 'overallOfficials': [{'name': 'Henri Roché, Pr', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Institut Claudius Regaud'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Institut Claudius Regaud', 'class': 'OTHER'}, 'collaborators': [{'name': 'Janssen-Cilag Ltd.', 'class': 'INDUSTRY'}]}}}