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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00237211
First Posted: October 12, 2005
Last Update Posted: February 23, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Chugai Pharmaceutical
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
  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: Intervention Model: Single Group Assignment
Masking: None (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 ( Novartis Pharmaceuticals ):

Primary Outcome Measures:
  • Safety during treatment [ Time Frame: 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 ]

Secondary Outcome Measures:
  • Pharmacokinetics measurement at baseline and at every 4 weeks until 28 weeks [ Time Frame: 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 ]
  • Duration of response [ Time Frame: 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 ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 74 Years   (Adult, Senior)
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Additional Information:
Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00237211     History of Changes
Other Study ID Numbers: CFEM345F1201
First Submitted: October 9, 2005
First Posted: October 12, 2005
Last Update Posted: February 23, 2017
Last Verified: February 2017

Keywords provided by Novartis ( Novartis Pharmaceuticals ):
Aromatase inhibitor
letrozole
breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Letrozole
Antineoplastic Agents
Aromatase Inhibitors
Steroid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Estrogen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs