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

Metastatic Breast Cancer Clinical Trial

— 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.

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00171847
• Other study ID #: CFEM345C2403
• Status: Terminated
• Phase: Phase 4
• First received: September 13, 2005
• Last updated: March 30, 2010
• Start date: March 2003

Study information

• Verified date: March 2010
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 93
• Est. primary completion date: October 2008
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Neoplasms
• Metastatic Breast Cancer

Intervention

Drug:
• Letrozole

• Trastuzumab plus Letrozole

• Letrozole

Locations

Country	Name	City	State
Germany	Novartis Investigative Site	Tuebingen

Sponsors (2)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals	Roche - Prof. Dr. Jens Huober et al.

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to progression as assessed by clinical palpation and radiologic imaging every 3 months		3 months	No
Secondary	Objective response rate/Clinical Benefit rate		3 months	No
Secondary	Time to treatment failure		3 months	No
Secondary	Duration of response/clinical benefit during treatment		3 months	No
Secondary	Overall survival		3 months	No