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

This study has been terminated.
Roche - Prof. Dr. Jens Huober et al.
Information provided by:
Novartis Identifier:
First received: September 13, 2005
Last updated: March 30, 2010
Last verified: March 2010
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
Intervention Model: Parallel Assignment
Masking: None (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 ]

Secondary Outcome Measures:
  • Objective response rate/Clinical Benefit rate [ Time Frame: 3 months ]
  • Time to treatment failure [ Time Frame: 3 months ]
  • Duration of response/clinical benefit during treatment [ Time Frame: 3 months ]
  • Overall survival [ Time Frame: 3 months ]

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


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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
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Please refer to this study by its identifier: NCT00171847

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

Responsible Party: External Affairs, Novartis Pharmaceuticals Identifier: NCT00171847     History of Changes
Other Study ID Numbers: CFEM345C2403
Study First Received: September 13, 2005
Last Updated: March 30, 2010

Keywords provided by Novartis:
Breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Antineoplastic Agents
Aromatase Inhibitors
Steroid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Estrogen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs processed this record on August 23, 2017