Antiestrogen vs Aromatase Inhibitor After Adjuvant Chemotherapy for Breast Cancer

• Status: Terminated
• Trial end date: 2020-05-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Japan Breast Cancer Research Network
• Treatments: Anastrozole; Aromatase Inhibitors; Citric Acid; Estrogen Antagonists; Estrogen Receptor Modulators; Toremifene

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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.