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

This study has been completed.
Sponsor:
Collaborator:
Chugai Pharmaceutical
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT00237211
First received: October 9, 2005
Last updated: May 9, 2012
Last verified: May 2012
  Purpose

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.


Condition Intervention Phase
Postmenopausal Women With Advanced Breast Cancer
Drug: Letrozole
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Study of High-dose Letrozole Therapy in Postmenopausal Patients With Breast Cancer

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • Safety during treatment [ Time Frame: Until disease progression or appearance of unacceptable toxicity whichever comes first ] [ Designated as safety issue: Yes ]
  • Response Rate during treatment [ Time Frame: Until disease progression or appearance of unacceptable toxicity whichever comes first ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Pharmacokinetics measurement at baseline and at every 4 weeks until 28 weeks [ Time Frame: Maximum 28 weeks after initiate treatment ] [ Designated as safety issue: No ]
  • Plasma estrogens level at baseline and at every 4 weeks until 28 weeks [ Time Frame: Maximum 28 weeks after initiate treatment ] [ Designated as safety issue: No ]
  • Duration of response [ Time Frame: From the first date of response confirmed and the last date of response confirmed ] [ Designated as safety issue: No ]
  • Time to progression [ Time Frame: From the first date of response confirmed and the last date of response confirmed ] [ Designated as safety issue: No ]

Enrollment: 31
Study Start Date: June 2001
Primary Completion Date: October 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Letrozole Drug: Letrozole
Other Name: FEM345

  Eligibility

Ages Eligible for Study:   20 Years to 74 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00237211

Locations
Japan
Novartis Investigative Site
Kashiwa, Chiba, Japan, 277-8577
Novartis Investigative Site
Matsuyama, Ehime, Japan, 791-0280
Novartis Investigative Site
Kooriyama, Fukushima, Japan, 963-8501
Novartis Investigative Site
Maebashi, Gunma, Japan, 371-8511
Novartis Investigative Site
Kurashiki, Okayama, Japan, 701-0192
Novartis Investigative Site
Kitaadachi-gun, Saitama, Japan, 338-8553
Novartis Investigative Site
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
Fukushima, Japan, 960-1295
Novartis Investigative Site
Osaka, Japan, 537-8511
Novartis Investigative Site
Saitama, Japan, 338-8553
Sponsors and Collaborators
Novartis Pharmaceuticals
Chugai Pharmaceutical
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

No publications provided

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT00237211     History of Changes
Other Study ID Numbers: CFEM345F1201
Study First Received: October 9, 2005
Last Updated: May 9, 2012
Health Authority: United States: Food and Drug Administration
Japan: Pharmaceuticals and Medical Devices Agency

Keywords provided by Novartis:
Aromatase inhibitor
letrozole
breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Letrozole
Aromatase Inhibitors
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on July 20, 2014