Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-26 @ 11:11 AM
Ignite Modification Date:
2025-12-26 @ 11:11 AM
NCT ID:
NCT00210028
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.
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT00210028
Study Brief:
Protocol Section:
NCT00210028