Postmenopausal breast cancer
Conditions
Interventions
Exemestane (25 mg Tablet) is orally administered once a day every day. Doxorubicin plus paclitaxel (AP) followed by weekly paclitaxel (wP).
Sponsors
Saitama Breast Cancer Clinical Study Group (SBCCSG)
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Patients histologically diagnosed with unilateral primary breast cancer. (Inflammatory breast cancer will be excluded.) 2. Patients whose tumor is 2 cm or more in diameter or who are axillary lymph node metastasis positive. 3. Patients whose primary lesion is immunohistochemically estrogen receptor (ER)-positive (10% or more staining) and 4. does not over-express HER2 (Herceptest score 0 or 1+, or in the case of 2+, FISH test signal ratio less than 2.0) 5. Patients who have not received endocrine therapy or chemotherapy for breast cancer 6. Patients who are menopausal and 20 to 65 years of age 7. Patients whose general condition is (ECOG Performance Status [PS]) 0 or 1 8. Patients from whom informed consent has been obtained in writing 9. Patients who have not undergone surgery Patients whose major organ function has been maintained as indicated by the following: 1) WBC count 3000/mm3 or neutrophil count 1500/mm3 2) Hemoglobin 9.0 g/dL 3) Platelet count 100,000 mm3 4) AST and ALT No more than 2.5 times the upper limit of normal values at the institution 5) Total bilirubin 1.5 g/dL 6) ECG Normal (patients with no heart disease or serious arrhythmias)
Exclusion criteria
Exclusion criteria: 1. Synchronous bilateral breast cancer 2. Patients with a serious complication 3. Patients who have a heart disease, such as ischemic heart disease, arrhythmias, etc., that require treatment (left ventricular hypertrophy associated with hypertension or mild left ventricle loading, mild right bundle branch block, etc., eligible for registration), and patients who have a history of myocardial infarction that occurred within the past 6 months 4. Patients with diabetes that is difficult to control, as a complication 5. Patients suspected of having an infection 6. Patients with a past history of serious hypersensitivity or patients with a history of hypersensitivity to the drugs used in this study or preparations containing polyoxyethylene castor oil (Cremophor EL) (cyclosporine injection, etc.) 7. Patients who are pregnant or breast feeding 8.Patients who for any other reason are judged to be unsuitable by the physician in charge
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pathological response rate | — |
Secondary
| Measure | Time frame |
|---|---|
| Clinical response rate, recurrence-free survival time, total survival time, rate of occurrence of adverse events, breast-conservation rate, treatment completion rate, biomarkers | — |
Countries
Japan
Contacts
Public ContactToshihiro Kai
Saitama Breast Cancer Clinical Study Group (SBCCSG) Executive office(c/o: Shin-toshin Ladies MammoClinic)
Outcome results
None listed