Study of High-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

NCT00237211

CFEM345F1201

Details and patient eligibility

About

To investigate the safety and efficacy of letrozole monotherapy at a dose of 2.5 mg/day in postmenopausal patients with breast cancer, and to determine the blood concentrations of letrozole and hormones.

Enrollment

31 patients

Sex

Female

Ages

20 to 74 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Patients with histologically documented breast cancer.
Patients with hormone receptor (ER and/or PgR) status of positive or unknown
Patients who have been amenorrheic for the preceding 12 months or more.
Patients who are 20 years or older and younger than 75 years.
Patients with a history of postoperative adjuvant therapy or a history of endocrine therapy with tamoxifen for the treatment of progression or recurrence of the lesion. The endocrine therapy, however, should not exceed one regimen.
Patients with progressing lesions.
Patients with sufficient organ function to evaluate the safety
Patients whose performance status (PS) is classified in 0～2.
Patients who have no residual effects from previous treatments

Exclusion criteria

Patients with other concurrent or previous malignant disease (excluding uterine carcinoma in-situ).
Patients with hypercalcemia and uncontrollable cardiac disease (including a history of serious cardiac disease)
Patients who have previously received aromatase inhibitor.
Patients who have lymphangitis-type lung metastasis or symptomatic brain metastasis.

Other protocol-defined inclusion / exclusion criteria may apply.