None listed
Conditions
Interventions
Exemestane 25 mg / celecoxib 400 mg Type of group
Patients will take one tablet of exemestane 25mg daily in the morning with food and two capsules of celecoxib 200mg twice daily with food.
Group name:exemestane 25 mg Type of group
Patients took an exemestane 25 mg tablet daily in the morning with food
Sponsors
PHARMACIA & UPJOHN INTERAMERICAN CORPORATION,
Eligibility
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:Physical exam Measure:Proportion of patients achieving a clinical benefit from the combination of exemestane and celecoxib, defined as objective tumor response. Timepoints:24 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:US-NCICTC criteria, version 2.0 Measure:Frequency of adverse events Timepoints:24 week | — |
Countries
Peru
Outcome results
None listed