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)

UMIN ID: UMIN000001298

Registered date:05/08/2008

Basic Information

• Recruitment status: Complete: follow-up continuing
• Health condition(s) or Problem(s) studied: Postmenopausal breast cancer
• Date of first enrollment: 2008/05/20
• Target sample size: 50
• Countries of recruitment: Japan
• Study type: Interventional
• Intervention(s): Exemestane (25 mg Tablet) is orally administered once a day every day. Doxorubicin plus paclitaxel (AP) followed by weekly paclitaxel (wP).

Outcome(s)

• Primary Outcome: Pathological response rate
• Secondary Outcome: Clinical response rate, recurrence-free survival time, total survival time, rate of occurrence of adverse events, breast-conservation rate, treatment completion rate, biomarkers

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 65years-old
• Gender: Female
• Exclude 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

Related Information

• Primary Sponsor: Saitama Breast Cancer Clinical Study Group (SBCCSG)
• Source(s) of Monetary Support: None