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

Breast Neoplasms Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00210028
• Other study ID #: 03 SEIN 04
• Status: Terminated
• Phase: Phase 2
• First received: September 13, 2005
• Last updated: November 10, 2006
• Start date: August 2003
• Est. completion date: August 2008

Study information

• Verified date: November 2006
• Source: Institut Claudius Regaud
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 40
• Est. completion date: August 2008
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Neoplasms

Intervention

Drug:
• Tamoxifen

• Zarnestra

Locations

Country	Name	City	State
France	Institut Bergonie	Bordeaux
France	Institut Val d'Aurelle_ Paul Lamarque	Montpellier
France	Institut Claudius Regaud	Toulouse

Sponsors (2)

Lead Sponsor	Collaborator
Institut Claudius Regaud	Janssen-Cilag Ltd.

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	To evaluate the time to progression
Secondary	To evaluate the clinical benefit (response + stable disease at 6 months)
Secondary	To evaluate the safety of the combination ZARNESTRA and tamoxifen
Secondary	To evaluate a possible pharmacokinetic interaction between ZARNESTRA and tamoxifen
Secondary	To evaluate the biological predictive and prognostic factors of a response