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

This study has been terminated.
Sponsor:
Collaborator:
Roche - Prof. Dr. Jens Huober et al.
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT00171847
First received: September 13, 2005
Last updated: March 30, 2010
Last verified: March 2010
  Purpose

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


Condition Intervention Phase
Metastatic Breast Cancer
Drug: Letrozole
Drug: Trastuzumab plus Letrozole
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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.

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • Time to progression as assessed by clinical palpation and radiologic imaging every 3 months [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Objective response rate/Clinical Benefit rate [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Time to treatment failure [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Duration of response/clinical benefit during treatment [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Overall survival [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Enrollment: 93
Study Start Date: March 2003
Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A - HER-2 +ve patients with Femara alone Drug: Letrozole
Experimental: B - HER-2 +ve patients with Femara + Herceptin Drug: Trastuzumab plus Letrozole
Experimental: C - HER-2 -ve patients with Femara alone Drug: Letrozole

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00171847

Locations
Germany
Novartis Investigative Site
Tuebingen, Germany
Sponsors and Collaborators
Novartis Pharmaceuticals
Roche - Prof. Dr. Jens Huober et al.
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmeceuticals
  More Information

No publications provided

Responsible Party: External Affairs, Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00171847     History of Changes
Other Study ID Numbers: CFEM345C2403
Study First Received: September 13, 2005
Last Updated: March 30, 2010
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Novartis:
Breast cancer
Metastatic
Trastuzumab
Letrozole

Additional relevant MeSH terms:
Breast Neoplasms
Breast Diseases
Neoplasms
Neoplasms by Site
Skin Diseases
Letrozole
Trastuzumab
Antineoplastic Agents
Aromatase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014