Prospective study of NEOadjuvant Anastrozole and RadioTherapy for hormone-responsive postmenopausal breast cancer (NEO-A-RT)

UMIN ID: UMIN000002266

Registered date:29/07/2009

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: early breast cancer
• Date of first enrollment: 2009/07/21
• Target sample size: 35
• Countries of recruitment: Japan
• Study type: Interventional
• Intervention(s): Patients will receive anastrozole 1mg daily for 24 weeks and receive radiotherapy (50Gy / 25 fr) at 13 weeks from the start of anastrozole. Patients will receive surgery at 24 weeks.

Outcome(s)

• Primary Outcome: Clinical response rate

Key inclusion & exclusion criteria

• Age minimum: Not applicable
• Age maximum: Not applicable
• Gender: Female
• Exclude criteria: 1) past history of any invasive malignancy within the previous 5 years 2) past history of breast cancer or synchronous bilateral breast cancer 3) past history of radiotherapy for ipsilateral breast 4) Suspicious of allergy for radiotherapy 5) Past use of aromatase inhibitors 6) Suspicious of allergy for aromatase inhibitors 7) Patients who had received or are receiving any steroids, estrogens or selective estrogen receptor modulators 8) Any reason the physician believes that the patient is not appropriate to participate in the study

Related Information

• Primary Sponsor: Osaka Medical Center for Cancer and Cardiovascular Diseases
• Source(s) of Monetary Support: Osaka Medical Center for Cancer and Cardiovascular Diseases