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

History of Changes

Tracking Information

First Received Date ^ICMJE

October 9, 2005

Last Updated Date

May 9, 2012

Start Date ^ICMJE

June 2001

Primary Completion Date

October 2006 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

Not Provided

Change History

Complete list of historical versions of study NCT00237211 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief Summary

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Postmenopausal Women With Advanced Breast Cancer

Intervention ^ICMJE

Drug: Letrozole

Other Name: FEM345

Study Arm (s)

Experimental: Letrozole

Intervention: Drug: Letrozole

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

Not Provided

Primary Completion Date

October 2006 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Gender

Female

Ages

20 Years to 74 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Japan

Administrative Information

NCT Number ^ICMJE

NCT00237211

Other Study ID Numbers ^ICMJE

CFEM345F1201

Has Data Monitoring Committee

Not Provided

Responsible Party

Novartis ( Novartis Pharmaceuticals )

Study Sponsor ^ICMJE

Novartis Pharmaceuticals

Collaborators ^ICMJE

Chugai Pharmaceutical

Investigators ^ICMJE

Study Director:

Novartis Pharmaceuticals

Information Provided By

Novartis

Verification Date

May 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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