Status:
TERMINATED
Study Assessing Efficacy of ZARNESTRA™ Combined With Tamoxifen in Patients With Advanced or Metastatic Breast Cancer
Lead Sponsor:
Institut Claudius Regaud
Collaborating Sponsors:
Janssen-Cilag Ltd.
Conditions:
Breast Neoplasms
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
Brief Summary
The purpose of this study is to evaluate the objective response rate when ZARNESTRA is added to treatment with tamoxifen
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 1 2003
Trial Type :
INTERVENTIONAL
End Date :
August 1 2008
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00210028
Start Date
August 1 2003
End Date
August 1 2008
Last Update
November 14 2006
Active Locations (3)
Enter a location and click search to find clinical trials sorted by distance.
1
Institut Bergonie
Bordeaux, France
2
Institut Val d'Aurelle_ Paul Lamarque
Montpellier, France
3
Institut Claudius Regaud
Toulouse, France