Letrozole in Metastatic Breast Cancer in Combination With Chemotherapy

This study has been completed.

Sponsor:

Information provided by:

Novartis

ClinicalTrials.gov Identifier:

NCT00333047

First received: May 31, 2006

Last updated: November 18, 2009

Last verified: November 2009

History of Changes

Tracking Information

First Received Date ^ICMJE

May 31, 2006

Last Updated Date

November 18, 2009

Start Date ^ICMJE

July 2002

Primary Completion Date

Not Provided

Current Primary Outcome Measures ^ICMJE

Objective response rate (complete remission, partial remission,no change, progressive disease) by clinical palpation and radiologic imaging every 3 months until disease progression

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00333047 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Time to progression and safety and toxicity during treatment

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Letrozole in Metastatic Breast Cancer in Combination With Chemotherapy

Official Title ^ICMJE

A Study of Letrozole in the Treatment of Metastatic Breast Cancer in Combination With Chemotherapy

Brief Summary

Therapeutic interventions for patients with metastatic breast cancer are aimed at prolonging survival and improving the quality of life. The objective of this trial is to assess if an initial chemotherapy followed by an endocrine therapy leads to a longer disease-free interval as compared to chemotherapy alone.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 2
Phase 3

Study Design ^ICMJE

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

Condition ^ICMJE

Metastatic Breast Cancer

Intervention ^ICMJE

Drug: Letrozole

Study Arm (s)

Not Provided

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

Not Provided

Eligibility Criteria ^ICMJE

Inclusion criteria

Histologically proven metastatic breast cancer
Measurable disease, patients with bone only disease are not eligible
Age ≥ 65 years
Performance status ≤ 2 (World Health Organization)
Estimated life expectancy under therapy of at least 3 months
Estrogen-/progesterone-receptor status positive or unknown
Signed informed consent

Exclusion criteria

Prior chemo- or hormone therapy for metastatic breast cancer; prior therapy with aromatase inhibitors in the adjuvant setting
Disease-free interval after adjuvant therapy < 1 year
Clinical signs of central nervous system metastases
Renal, bone marrow, or liver insufficiency
Severe coronary heart disease, cardiac insufficiency or other severe concomitant internal diseases
Pulmonary fibrosis/alveolitis Additional protocol-defined inclusion/exclusion criteria may apply.

Gender

Female

Ages

65 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Germany

Administrative Information

NCT Number ^ICMJE

NCT00333047

Other Study ID Numbers ^ICMJE

CFEM345ADE07

Has Data Monitoring Committee

Not Provided

Responsible Party

Not Provided

Study Sponsor ^ICMJE

Novartis

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Chair:

Novartis

Information Provided By

Novartis

Verification Date

November 2009

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

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