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Sponsors and Collaborators: |
Institut Claudius Regaud Janssen-Cilag Ltd. |
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Information provided by: | Institut Claudius Regaud |
ClinicalTrials.gov Identifier: | NCT00210028 |
The purpose of this study is to evaluate the objective response rate when ZARNESTRA is added to treatment with tamoxifen
Condition | Intervention | Phase |
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Breast Neoplasms |
Drug: Tamoxifen Drug: Zarnestra |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study |
Official Title: | 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 |
Estimated Enrollment: | 40 |
Study Start Date: | August 2003 |
Estimated Study Completion Date: | August 2008 |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Neutrophils ≥ 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
Exclusion Criteria:
France | |
Institut Claudius Regaud | |
Toulouse, France | |
Institut Bergonie | |
Bordeaux, France | |
Institut Val d'Aurelle_ Paul Lamarque | |
Montpellier, France |
Principal Investigator: | Henri Roché, Pr | Institut Claudius Regaud |
Study ID Numbers: | 03 SEIN 04 |
Study First Received: | September 13, 2005 |
Last Updated: | November 10, 2006 |
ClinicalTrials.gov Identifier: | NCT00210028 History of Changes |
Health Authority: | France: Afssaps - French Health Products Safety Agency |
Breast Neoplasms Zarnestra Tamoxifen estrogen receptor progesterone receptor |
Estrogen Antagonists Estrogens Skin Diseases Progesterone Antineoplastic Agents, Hormonal Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists Breast Neoplasms |
Bone Density Conservation Agents Selective Estrogen Receptor Modulators Tamoxifen Hormones Estrogen Receptor Modulators Breast Diseases Tipifarnib |
Estrogen Antagonists Skin Diseases Antineoplastic Agents, Hormonal Antineoplastic Agents Hormone Antagonists Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Breast Neoplasms Bone Density Conservation Agents |
Selective Estrogen Receptor Modulators Tamoxifen Pharmacologic Actions Estrogen Receptor Modulators Neoplasms Neoplasms by Site Therapeutic Uses Breast Diseases Tipifarnib |