Study Assessing Efficacy of ZARNESTRA™ Combined With Tamoxifen in Patients With Advanced or Metastatic Breast Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00210028
Recruitment Status : Terminated
First Posted : September 21, 2005
Last Update Posted : November 14, 2006
Janssen-Cilag Ltd.
Information provided by:
Institut Claudius Regaud

Brief Summary:
The purpose of this study is to evaluate the objective response rate when ZARNESTRA is added to treatment with tamoxifen

Condition or disease Intervention/treatment Phase
Breast Neoplasms Drug: Tamoxifen Drug: Zarnestra Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : August 2003
Estimated Study Completion Date : August 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
U.S. FDA Resources

Primary Outcome Measures :
  1. 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

Secondary Outcome Measures :
  1. To evaluate the time to progression
  2. To evaluate the clinical benefit (response + stable disease at 6 months)
  3. To evaluate the safety of the combination ZARNESTRA and tamoxifen
  4. To evaluate a possible pharmacokinetic interaction between ZARNESTRA and tamoxifen
  5. To evaluate the biological predictive and prognostic factors of a response

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Histologically proven, metastatic or locally advanced inoperable breast cancer
  • 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.
  • 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.
  • Post-menopausal patients
  • Age > 18 years
  • 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
  • Performance Status (WHO): PS ≤ 2 (Appendix 1).
  • Laboratory tests in accordance with the following 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

  • Signed, written consent before any study-related procedure

Exclusion Criteria:

  • Men
  • Pre-menopausal patients who are not receiving concurrent LHRH agonist therapy
  • ER- and PR-negative patients
  • Contraindication to antiestrogens (thromboembolic risk) or ZARNESTRA
  • Non metastatic tumor susceptible to management by radiotherapeutic and/or surgical means
  • T4d inflammatory tumor (PEV 2 or 3).
  • Short-term, life-threatening lesions: hepatic invasion > 1/3 of liver volume, pulmonary lymphangitis, uncontrolled cerebral metastases, carcinomatous meningitis
  • Sensory neuropathy > or = grade 1 (WHO)
  • Previous history of uncontrolled cancers or controlled for less than 5 years, except basal cell skin cancers and in situ cancers of the cervix.
  • Chronic diseases (somatic or psychiatric) with a poor prognosis
  • subjects with enzyme-inducing anti-convulsants (e.g., phenytoin, phenobarbital, carbamazepine) : this treatment is not permitted while taking ZARNESTRA
  • Patients who, for family, social, geographic or psychological reasons, could not be followed up correctly.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00210028

Institut Bergonie
Bordeaux, France
Institut Val d'Aurelle_ Paul Lamarque
Montpellier, France
Institut Claudius Regaud
Toulouse, France
Sponsors and Collaborators
Institut Claudius Regaud
Janssen-Cilag Ltd.
Principal Investigator: Henri Roché, Pr Institut Claudius Regaud Identifier: NCT00210028     History of Changes
Other Study ID Numbers: 03 SEIN 04
First Posted: September 21, 2005    Key Record Dates
Last Update Posted: November 14, 2006
Last Verified: November 2006

Keywords provided by Institut Claudius Regaud:
Breast Neoplasms
estrogen receptor
progesterone receptor

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Estrogen Antagonists
Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Selective Estrogen Receptor Modulators
Estrogen Receptor Modulators
Bone Density Conservation Agents