Status:
TERMINATED
Antiestrogen vs Aromatase Inhibitor After Adjuvant Chemotherapy for Breast Cancer
Lead Sponsor:
Japan Breast Cancer Research Network
Conditions:
Breast Neoplasms
Eligibility:
FEMALE
Phase:
PHASE2
Brief Summary
To investigate the benefit of postoperative adjuvant therapy using sequential administration of the hormone, toremifene citrate (TOR) or anastrozole (ANA), after chemotherapy in breast cancer.
Detailed Description
To investigate the benefit of postoperative adjuvant therapy using sequential administration of the hormone, toremifene citrate (TOR) or anastrozole (ANA), after chemotherapy in breast cancer. TOR is...
Eligibility Criteria
Inclusion
- Written consent obtained for study participation.
- Breast cancer diagnosed histologically with a breast removed or preserved.
- Positive ER or PR testing by immunohistochemistry (IHC), enzyme immunoassay (EIA) and who meet the criteria of each institution.
- HER2 evaluation.
- Patient Status (PS): 0 or 1.
- Fully functional heart, liver, kidneys, and bone marrow.
- More than one year since last menstruation or tested postmenopausal from estradiol (E2) and follicle-stimulating hormone (FSH) levels based on evaluation standard of each institution.
- Expected to live for at least three months (or longer) after study commencement.
Exclusion
- Pregnant or breast feeding.
- Bilateral or inflammatory breast cancer.
- Multiple cancers.
- Life-threatening metastases.
- History of serious hypersensitivity.
- Judged ineligible for the study by the study doctor.
Key Trial Info
Start Date :
May 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2020
Estimated Enrollment :
240 Patients enrolled
Trial Details
Trial ID
NCT00437359
Start Date
May 1 2007
End Date
May 1 2020
Last Update
March 30 2012
Active Locations (7)
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1
Kyushu Central Hospital
Fukuoka, Japan, 815-8588
2
Kansai Medical University Hirakata Hospital
Hirakata, Japan, 573-1191
3
Hirosaki University Hospital
Hirosaki, Japan, 036-8563
4
Hiroshima University Hospital
Hiroshima, Japan, 734-8551