Study of Safety and Efficacy of Letrozole Monotherapy as Second-line Endocrine Therapy in Postmenopausal Patients With Advanced Breast Cancer Who Received Previous Anti-estrogen Treatment

February 21, 2017 updated by: Novartis Pharmaceuticals
  • Safety and efficacy of letrozole 2.5 mg/day monotherapy as second-line endocrine therapy in postmenopausal patients with advanced breast cancer who received previous anti-estrogen treatment
  • To investigate changes in blood drug concentrations and blood hormone kinetics.
  • To investigate gene polymorphisms of CYP2A6, an enzyme involved in the metabolism of letrozole

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

47

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
      • Fukuoka, Japan, 811-1395
        • Novartis Investigative Site
      • Fukushima, Japan, 960-1295
        • Novartis Investigative Site
      • Niigata, Japan, 951-8566
        • Novartis Investigative Site
      • Osaka, Japan, 537-8511
        • Novartis Investigative Site
      • Shizuoka, Japan, 420-0881
        • Novartis Investigative Site
    • Aichi
      • Nagoya, Aichi, Japan, 464-8681
        • Novartis Investigative Site
      • Nagoya, Aichi, Japan, 465-0024
        • 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
    • Hiroshima
      • Kure, Hiroshima, Japan, 737-0023
        • Novartis Investigative Site
    • Hokkaido
      • Sapporo, Hokkaido, Japan, 003-0804
        • Novartis Investigative Site
      • Sapporo, Hokkaido, Japan, 060-0001
        • Novartis Investigative Site
      • Sapporo, Hokkaido, Japan, 063-0812
        • Novartis Investigative Site
    • Kanagawa
      • Yokohama, Kanagawa, Japan, 241-0815
        • Novartis Investigative Site
    • Okayama
      • Kurashiki, Okayama, Japan, 701-0192
        • Novartis Investigative Site
    • Saitama
      • Kitaadachi-gun, Saitama, Japan, 338-8553
        • Novartis Investigative Site
    • Shizuoka
      • Sunto-gun, Shizuoka, Japan, 411-8777
        • Novartis Investigative Site
    • Tokyo
      • Bunkyo-ku, Tokyo, Japan, 113-8677
        • Novartis Investigative Site
      • Chuo-ku, Tokyo, Japan, 104-0045
        • Novartis Investigative Site
      • Cyuo-ku, Tokyo, Japan, 104-8560
        • Novartis Investigative Site
      • Koto, Tokyo, Japan, 135-8550
        • 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

20 years to 79 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Patients with histologically or cytologically documented breast cancer
  • Patients with progressive breast cancer (advanced breast cancer, locoregional recurrence not operative, or metastatic breast cancer)
  • Patients with hormone receptor (ER and/or PgR) positive or both unknown.
  • Postmenopausal patients between ages 20 and 79 years, inclusive
  • Patients with a history of adjuvant therapy or advanced breast cancer treated with anti-estrogens
  • Patients with documented measurable or evaluable lesions.
  • Patients with sufficient organ function to evaluate the safety
  • Patients whose performance status (PS) is 0～2

Exclusion Criteria:

  • Patients with diffuse lymphangitis carcinomatosa of the lung or CNS involvement, liver metastasis occupying more than one third of the liver, or inflammatory breast cancer
  • Patients with other concurrent or previous malignant disease (excluding contralateral breast cancer, in situ carcinoma of cervix uteri, and adequately treated basal or squamous cell carcinoma of the skin)
  • Patients in whom one of the following is the sole manifestation of disease: hilar enlargement, pleural effusion and ascites
  • Patients with only blastic bone metastases or a mixed blastic and lytic bone metastases at the same site and no other measurable or evaluable lesions
  • Patients with serious current disease such as uncontrolled cardiac diseases and/or uncontrolled diabetes mellitus by any medications (including a historical serious cardiac disease)
  • Patients with adrenal insufficiency (treated or untreated) or Cushing's syndrome

  • Patients with any of the following previous treatments

    1. Chemotherapy for metastatic and/or locoregional recurrent disease
    2. Previous adjuvant endocrine therapy other than ovariectomy, anti-estrogen treatment, LH-RH analogues or radiation castration
    3. Previous first-line endocrine therapy (e.g., aromatase inhibitors and gastagens) for the treatment of metastatic and/or locoregional recurrent breast cancer other than anti-estrogen or LH-RH analogues treatment
    4. Patients who have not recovered from toxicity caused by previous therapy
    5. For patients on investigational drugs, adequate wash-out periods of at least 7 days in the case of topical investigational drugs and at least 30 days in the case of systemic
    6. Previous bisphosphonate therapy started within 6 months without any other measurable or evaluable lesions
    7. Patients who have not stopped treatment with other anti-estrogen or anti-cancer drugs (other than bisphosphonates) before starting the trial medication

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
Clinical Benefit 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
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
Time to treatment failure
Time Frame: from the date of study initiation and the date of disease progression confirmed or discontinuation other than disease progression
from the date of study initiation and the date of disease progression confirmed or discontinuation other than disease progression
Plasma drug concentration from baseline, every 4 weeks until 28 weeks, at 40 weeks and at 52 weeks
Time Frame: Baseline, 52 weeks
Baseline, 52 weeks
Plasma estrogens level
Time Frame: baseline, 52 weeks
baseline, 52 weeks

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

March 1, 2004

Primary Completion (Actual)

July 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)

February 23, 2017

Last Update Submitted That Met QC Criteria

February 21, 2017

Last Verified

February 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CFEM345F1203

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.

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