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Study of the Efficacy and Safety of Letrozole Combined With Trastuzumab in Patients With Metastatic Breast Cancer (eLEcTRA)

Primary Purpose

Metastatic Breast Cancer

Status

Terminated

Phase

Phase 4

Locations

Germany

Study Type

Interventional

Intervention

Letrozole

Trastuzumab plus Letrozole

Letrozole

About this trial

This is an interventional treatment trial for Metastatic Breast Cancer focused on measuring Breast cancer, Metastatic, Trastuzumab, Letrozole

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria: Postmenopausal Her-2 overexpression and ER and/or PgR positive Metastatic Breast Cancer Exclusion Criteria: Previous treatment with trastuzumab Significant Liver or renal impairment Erbb2 negative and/or ER and PgR negative Other protocol-defined inclusion / exclusion criteria may apply.

Sites / Locations

Novartis Investigative Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Arm Label

A - HER-2 +ve patients with Femara alone

B - HER-2 +ve patients with Femara + Herceptin

C - HER-2 -ve patients with Femara alone

Arm Description

Outcomes

Primary Outcome Measures

Time to progression as assessed by clinical palpation and radiologic imaging every 3 months

Secondary Outcome Measures

Objective response rate/Clinical Benefit rate

Time to treatment failure

Duration of response/clinical benefit during treatment

Overall survival

Full Information

NCT ID

NCT00171847

First Posted

September 13, 2005

Last Updated

March 30, 2010

Sponsor

Novartis Pharmaceuticals

Collaborators

Roche - Prof. Dr. Jens Huober et al.

1. Study Identification

Unique Protocol Identification Number

NCT00171847

Brief Title

Study of the Efficacy and Safety of Letrozole Combined With Trastuzumab in Patients With Metastatic Breast Cancer

Acronym

eLEcTRA

Official Title

An Open Label, Randomized Comparison of Femara® 2.5mg Once Daily With or Without Weekly Herceptin® Until Disease Progression as First-line Treatment in Postmenopausal Women With Advanced Breast Cancer.

Study Type

Interventional

2. Study Status

Record Verification Date

March 2010

Overall Recruitment Status

Terminated

Study Start Date

March 2003 (undefined)

Primary Completion Date

October 2008 (Actual)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

Novartis Pharmaceuticals

Collaborators

Roche - Prof. Dr. Jens Huober et al.

4. Oversight

5. Study Description

Brief Summary

Phase IV trial to investigate the effect of the combination of Letrozole with trastuzumab in metastatic breast cancer patients

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Metastatic Breast Cancer

Keywords

Breast cancer, Metastatic, Trastuzumab, Letrozole

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

93 (Actual)

8. Arms, Groups, and Interventions

Arm Title

A - HER-2 +ve patients with Femara alone

Arm Type

Experimental

Arm Title

B - HER-2 +ve patients with Femara + Herceptin

Arm Type

Experimental

Arm Title

C - HER-2 -ve patients with Femara alone

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

Letrozole

Intervention Type

Drug

Intervention Name(s)

Trastuzumab plus Letrozole

Intervention Type

Drug

Intervention Name(s)

Letrozole

Primary Outcome Measure Information:

Title

Time to progression as assessed by clinical palpation and radiologic imaging every 3 months

Time Frame

3 months

Secondary Outcome Measure Information:

Title

Objective response rate/Clinical Benefit rate

Time Frame

3 months

Title

Time to treatment failure

Time Frame

3 months

Title

Duration of response/clinical benefit during treatment

Time Frame

3 months

Title

Overall survival

Time Frame

3 months

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Novartis Pharmaceuticals

Organizational Affiliation

Novartis Pharmeceuticals

Official's Role

Study Director

Facility Information:

Facility Name

Novartis Investigative Site

City

Tuebingen

Country

Germany

12. IPD Sharing Statement

Learn more about this trial

Study of the Efficacy and Safety of Letrozole Combined With Trastuzumab in Patients With Metastatic Breast Cancer

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