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

November 13, 2018 updated by: Novartis Pharmaceuticals
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

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

31

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 72 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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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
Time Frame: Until disease progression or appearance of unacceptable toxicity whichever comes first
Until disease progression or appearance of unacceptable toxicity whichever comes first
Response Rate during treatment
Time Frame: Until disease progression or appearance of unacceptable toxicity whichever comes first
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
Time Frame: Maximum 28 weeks after initiate treatment
Maximum 28 weeks after initiate treatment
Plasma estrogens level at baseline and at every 4 weeks until 28 weeks
Time Frame: Maximum 28 weeks after initiate treatment
Maximum 28 weeks after initiate treatment
Duration of response
Time Frame: From the first date of response confirmed and the last date of response confirmed
From the first date of response confirmed and the last date of response confirmed
Time to progression
Time Frame: From the first date of response confirmed and the last date of response confirmed
From the first date of response confirmed and the last date of response confirmed

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novartis Pharmaceuticals

Collaborators

Chugai Pharmaceutical

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CFEM345F1201

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Postmenopausal Women With Advanced Breast Cancer

Clinical Trials on Letrozole

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Italy

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe