Phase II study of exemestane with doxorubicin plus paclitaxel (AP) followed by weekly paclitaxel (wP) as primary systemic chemotherapy for hormone-sensitive and HER2-negative postmenopausal breast cancer (SBCCSG-13 EAPAC)
- Conditions
- Postmenopausal breast cancer
- Registration Number
- JPRN-UMIN000001298
- Lead Sponsor
- Saitama Breast Cancer Clinical Study Group (SBCCSG)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up continuing
- Sex
- Female
- Target Recruitment
- 50
Not provided
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Pathological response rate
- Secondary Outcome Measures
Name Time Method Clinical response rate, recurrence-free survival time, total survival time, rate of occurrence of adverse events, breast-conservation rate, treatment completion rate, biomarkers