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Extension Study of 1.0mg Dose Letrozole Therapy in Postmenopausal Patients With Breast Cancer

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.
 
ClinicalTrials.gov Identifier: NCT00247663
Recruitment Status : Completed
First Posted : November 2, 2005
Last Update Posted : April 19, 2012
Sponsor:
Collaborator:
Chugai Pharmaceutical
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Brief Summary:
- To investigate the safety of letrozole monotherapy at a dose 1.0 mg/day or fadrozole monotherapy at a dose 2.0mg in Japanese postmenopausal patients with advanced breast cancer which participated in double blind study.

Condition or disease Intervention/treatment Phase
Postmenopausal Women With Advanced Breast Cancer Drug: Letrozole Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 17 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Extension Study of 1.0mg Dose Letrozole Therapy in Postmenopausal Patients With Breast Cancer
Study Start Date : December 1999
Actual Primary Completion Date : December 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
Drug Information available for: Letrozole

Arm Intervention/treatment
Experimental: Letrozole Drug: Letrozole
Other Name: FEM345




Primary Outcome Measures :
  1. Safety during treatment

Secondary Outcome Measures :
  1. No secondary outcomes/objectives planned


Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 74 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

- Patients which participated in double blind study

Exclusion Criteria:

  • Patients with intolerable toxicity.
  • Patients which confirmed progressive disease during double blind study.
  • Patients which have received concurrent anti-cancer therapy during double blind study.

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): NCT00247663


Locations
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Japan
Novartis Investigative Site
Kashiwa, Chiba, Japan, 277-8577
Novartis Investigative Site
Amagasaki, Hyogo, Japan, 660-8511
Novartis Investigative Site
Hamamatsu, Shizuoka, Japan, 430-8558
Novartis Investigative Site
Chuo-Ku, Tokyo, Japan, 104-0045
Novartis Investigative Site
Cyuo-ku, Tokyo, Japan, 104-8560
Novartis Investigative Site
Shinjuku-ku, Tokyo, Japan, 160-8582
Novartis Investigative Site
Fukuoka, Japan, 811-4395
Novartis Investigative Site
Kumamoto, Japan, 862-0909
Novartis Investigative Site
Nigata, Japan, 951-8566
Novartis Investigative Site
Saitama, Japan, 338-8553
Sponsors and Collaborators
Novartis Pharmaceuticals
Chugai Pharmaceutical
Investigators
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Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals

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Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00247663    
Other Study ID Numbers: CFEM345 1601
First Posted: November 2, 2005    Key Record Dates
Last Update Posted: April 19, 2012
Last Verified: April 2012
Keywords provided by Novartis ( Novartis Pharmaceuticals ):
Aromatase inhibitor
letrozole
breast cancer
Additional relevant MeSH terms:
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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