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

Sponsor

Institut Claudius Regaud (Other)

Overall Status

Terminated

CT.gov ID

NCT00210028

Collaborator

Janssen-Cilag Ltd. (Industry)

Enrollment

Locations

Duration (Months)

13.3

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

Study Description

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 Design

Study Type:

Interventional

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 :

Aug 1, 2003

Study Completion Date :

Aug 1, 2008

Outcome Measures

Primary Outcome Measures

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

To evaluate the time to progression []
To evaluate the clinical benefit (response + stable disease at 6 months) []
To evaluate the safety of the combination ZARNESTRA and tamoxifen []
To evaluate a possible pharmacokinetic interaction between ZARNESTRA and tamoxifen []
To evaluate the biological predictive and prognostic factors of a response []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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.