Breast Neoplasms
Conditions
Keywords
Breast Neoplasms, Zarnestra, Tamoxifen, estrogen receptor, progesterone receptor
Brief summary
The purpose of this study is to evaluate the objective response rate when ZARNESTRA is added to treatment with tamoxifen
Interventions
DRUGTamoxifen
DRUGZarnestra
Sponsors
Janssen-Cilag Ltd.
Institut Claudius Regaud
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 | — |
| To evaluate the time to progression | — |
Countries
France
Outcome results
None listed