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

Institut Claudius Regaud

Status and phase

Terminated

Phase 2

Conditions

Breast Neoplasms

Treatments

Drug: Tamoxifen

Drug: Zarnestra

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT00210028

03 SEIN 04

Details and patient eligibility

About

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

Sex

Female

Ages

18+ years old

Volunteers

No 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.