OPEN STUDY, MULTICENTER, CONTROLLED OF EXEMESTANE (AROMASIN) WITH OR WITHOUT CELECOXIB (CELEBREX) IN POSTMENOPAUSIC WOMEN WITH ADVANCED BREAST CANCER (CAM) THAT HAS PROGRESSED DESPITE TAMOXIFE
- Conditions
- -C50 Malignant neoplasm of breastMalignant neoplasm of breastC50
- Registration Number
- PER-025-02
- Lead Sponsor
- PHARMACIA & UPJOHN INTERAMERICAN CORPORATION,
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- Not specified
- Target Recruitment
- 0
1) Patients postmenopausal women with breast cancer confirmed histologically or cytologically.
2) Advanced disease: patients with advanced breast carcinoma with progression of disease who have progressed / relapsed after> 8 weeks of treatment with Tamoxifen for advanced disease.
3)> 3 weeks from the last chemotherapy and> 4 weeks since the last radiotherapy.
4) Recovery of all acute toxicities by previous treatment (except alopecia), and of any major surgery.
1) More than one previous chemotherapy and / or more than one hormone therapy for advanced disease.
2) Hormonotherapy for advanced disease other than Tamoxifen.
3) Any other concomitant anticancer treatment.
4) Previous use (within 4 weeks of the start of treatment) or concomitant hormone replacement therapy or progestogen therapy.
5) Use of LH / RH agonists in the three months prior to the start of treatment.
6) Presence of brain metastasis, compression of the spinal cord or carcinomatous meningitis.
7) Other concomitant malignancies
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method