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

Phase 2

Completed

• Conditions: Postmenopausal Women With Advanced Breast Cancer
• Interventions: Drug: Letrozole

• Registration Number: NCT00237211
• Lead Sponsor: Novartis Pharmaceuticals

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2001-06
• Study First Submitted: 2005-10-09
• Study First Submitted QC: 2005-10-09
• Study First Posted: 2005-10-12
• Primary Completion: 2006-10
• Study Completion: 2006-10
• Status Verified: 2018-11
• Last Update Submitted: 2018-11-13
• Last Update Posted: 2018-11-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 31

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Letrozole	Letrozole	-

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

Novartis Investigative Site; 🇯🇵 Saitama, Japan