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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.
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
History of Changes

September 13, 2005
March 30, 2010
March 2003
October 2008   (final data collection date for primary outcome measure)
Time to progression as assessed by clinical palpation and radiologic imaging every 3 months [ Time Frame: 3 months ] [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00171847 on ClinicalTrials.gov Archive Site
  • 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 ]
Not Provided
Not Provided
Not Provided
 
Study of the Efficacy and Safety of Letrozole Combined With Trastuzumab in Patients With Metastatic Breast Cancer
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.

Phase IV trial to investigate the effect of the combination of Letrozole with trastuzumab in metastatic breast cancer patients
Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Metastatic Breast Cancer
  • Drug: Letrozole
  • Drug: Trastuzumab plus Letrozole
  • Experimental: A - HER-2 +ve patients with Femara alone
    Intervention: Drug: Letrozole
  • Experimental: B - HER-2 +ve patients with Femara + Herceptin
    Intervention: Drug: Trastuzumab plus Letrozole
  • Experimental: C - HER-2 -ve patients with Femara alone
    Intervention: Drug: Letrozole
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
93
Not Provided
October 2008   (final data collection date for primary outcome measure)

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.
Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT00171847
CFEM345C2403
Not Provided
External Affairs, Novartis Pharmaceuticals
Novartis Pharmaceuticals
Roche - Prof. Dr. Jens Huober et al.
Study Director: Novartis Pharmaceuticals Novartis Pharmeceuticals
Novartis
March 2010

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