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

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.

Study Overview

• Status: Completed
• Conditions: Postmenopausal Women With Advanced Breast Cancer
• Intervention / Treatment: Drug: Letrozole

• Study Type: Interventional
• Enrollment (Actual): 31
• Phase: Phase 2

Contacts and Locations

Study Locations

• Japan
  • Fukushima, Japan, 960-1295
    • Novartis Investigative Site
  • Osaka, Japan, 537-8511
    • Novartis Investigative Site
  • Saitama, Japan, 338-8553
    • Novartis Investigative Site
  • Chiba
    • Kashiwa, Chiba, Japan, 277-8577
      • Novartis Investigative Site
  • Ehime
    • Matsuyama, Ehime, Japan, 791-0280
      • Novartis Investigative Site
  • Fukushima
    • Kooriyama, Fukushima, Japan, 963-8501
      • Novartis Investigative Site
  • Gunma
    • Maebashi, Gunma, Japan, 371-8511
      • Novartis Investigative Site
  • Okayama
    • Kurashiki, Okayama, Japan, 701-0192
      • Novartis Investigative Site
  • Saitama
    • Kitaadachi-gun, Saitama, Japan, 338-8553
      • Novartis Investigative Site
  • Tokyo
    • Bunkyo-ku, Tokyo, Japan, 113-8677
      • Novartis Investigative Site
    • Chuo-ku, Tokyo, Japan, 104-0045
      • Novartis Investigative Site
    • Shinjuku-ku, Tokyo, Japan, 160-8582
      • Novartis Investigative Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Letrozole	Drug: Letrozole; Other Names: FEM345

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Novartis Pharmaceuticals
• Collaborators: Chugai Pharmaceutical

Study record dates

Study Major Dates

• Study Start: June 1, 2001
• Primary Completion (Actual): October 1, 2006
• Study Completion (Actual): October 1, 2006

Study Registration Dates

• First Submitted: October 9, 2005
• First Submitted That Met QC Criteria: October 9, 2005
• First Posted (Estimate): October 12, 2005

Study Record Updates

• Last Update Posted (Actual): November 14, 2018
• Last Update Submitted That Met QC Criteria: November 13, 2018
• Last Verified: November 1, 2018

More Information

Terms related to this study

• Keywords: breast cancer; letrozole; Aromatase inhibitor
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antineoplastic Agents; Hormones, Hormone Substitutes, and Hormone Antagonists; Hormone Antagonists; Aromatase Inhibitors; Steroid Synthesis Inhibitors; Estrogen Antagonists; Letrozole
• Other Study ID Numbers: CFEM345F1201