Clinical trial NCT00210028 (phase 2, status: terminated)
Conditions: breast neoplasms
ICD codes: C79.81, D24.1, D24.2, D24.9, D49.3, C44.501, D48.60
Drugs: tamoxifen, zarnestra
SMILES: OC1=CC=C(C=C1)C1=C(C(=O)C2=CC=C(OCCN3CCCCC3)C=C2)C2=C(S1)C=C(O)C=C2, CN1C=NC=C1[C@@](N)(C1=CC=C(Cl)C=C1)C1=CC2=C(C=C1)N(C)C(=O)C=C2C1=CC(Cl)=CC=C1
Eligibility criteria:

        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.