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A Study of Letrozole in the Treatment of Endometrial 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. Identifier: NCT00333086
Recruitment Status : Completed
First Posted : June 2, 2006
Last Update Posted : April 19, 2012
Canadian Cancer Trials Group
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Brief Summary:
Currently available treatments for endometrial cancer are associated with limited efficacy and significant toxicity. This study will assess the safety and efficacy of letrozole, an aromatase inhibitor, on endometrial cancer.

Condition or disease Intervention/treatment Phase
Recurrent and Metastatic Endometrial Cancer Drug: Letrozole Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 36 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : January 2000
Primary Completion Date : June 2006

Resource links provided by the National Library of Medicine

Drug Information available for: Letrozole
U.S. FDA Resources

Primary Outcome Measures :
  1. Response rates (complete response, partial response, no change, progressive disease) measured by tumor marker assessments and radiologic imaging at week 12 then every 12 weeks x 1 year followed by every 16 weeks

Secondary Outcome Measures :
  1. Duration of clinical response, time to progression of the disease, correlation of tumor response with pretreatment ER/PR status, histological grade and aromatase levels

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Inclusion criteria

  • Postmenopausal women with recurrent or metastatic adeno- or adenosquamous carcinoma of the endometrium
  • No adjuvant therapy
  • Up to one prior hormonal (progestin) therapy for advanced/metastatic disease allowed
  • No chemotherapy for recurrence (adjuvant permitted)
  • Unidimensionally measurable disease
  • Good Health status 0-2 (Eastern Cooperatitve Oncology Group)
  • No prior tamoxifen or aromatase inhibitor therapy
  • No other concurrent anti-cancer treatment
  • No metastases in the central nervous system

Exclusion criteria:

Additional protocol-defined inclusion/exclusion criteria may apply

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 identifier (NCT number): NCT00333086

Novartis Investigative Site
Heidelberg, Germany
Sponsors and Collaborators
Novartis Pharmaceuticals
Canadian Cancer Trials Group
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals

Responsible Party: Novartis Pharmaceuticals Identifier: NCT00333086     History of Changes
Other Study ID Numbers: CFEM345ADE03
First Posted: June 2, 2006    Key Record Dates
Last Update Posted: April 19, 2012
Last Verified: April 2012

Keywords provided by Novartis ( Novartis Pharmaceuticals ):
Endometrial Cancer
Aromatase inhibitor

Additional relevant MeSH terms:
Endometrial Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Uterine Diseases
Genital Diseases, Female
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