Extension Study of 1.0mg Dose Letrozole Therapy in Postmenopausal Patients With Breast Cancer

Novartis

Status and phase: Completed; Phase 2

Conditions: Postmenopausal Women With Advanced Breast Cancer

Treatments: Drug: Letrozole

Study type: Interventional

Funder types: Industry

Identifiers

NCT00247663

CFEM345 1601

Details and patient eligibility

About

• To investigate the safety of letrozole monotherapy at a dose 1.0 mg/day or fadrozole monotherapy at a dose 2.0mg in Japanese postmenopausal patients with advanced breast cancer which participated in double blind study.

Enrollment: 17 patients

Sex: Female

Ages: 20 to 74 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients which participated in double blind study

Exclusion criteria

• Patients with intolerable toxicity.
• Patients which confirmed progressive disease during double blind study.
• Patients which have received concurrent anti-cancer therapy during double blind study.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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17 participants in 1 patient group

Letrozole

Experimental group

Treatment:

Drug: Letrozole