Study of High-dose Letrozole Therapy in Postmenopausal Patients With Breast Cancer

Study Overview
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Brief Summary
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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.

Official Title
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Study of High-dose Letrozole Therapy in Postmenopausal Patients With Breast Cancer

Conditions
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Postmenopausal Women With Advanced Breast Cancer

Intervention / Treatment
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* Drug: Letrozole


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 74 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Letrozole<br> | Drug: Letrozole<br> <br> * Other names: FEM345;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety during treatment |  | Until disease progression or appearance of unacceptable toxicity whichever comes first | 
| Response Rate during treatment |  | Until disease progression or appearance of unacceptable toxicity whichever comes first | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics measurement at baseline and at every 4 weeks until 28 weeks |  | Maximum 28 weeks after initiate treatment | 
| Plasma estrogens level at baseline and at every 4 weeks until 28 weeks |  | Maximum 28 weeks after initiate treatment | 
| Duration of response |  | From the first date of response confirmed and the last date of response confirmed | 
| Time to progression |  | From the first date of response confirmed and the last date of response confirmed | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Aromatase inhibitor, letrozole, breast cancer