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A Study to Evaluate the Efficacy and Safety of Herceptin (Trastuzumab) in Combination With an Aromatase Inhibitor in Patients With Metastatic Breast Cancer

This study has been completed.
Sponsor:
Collaborator:
Genentech
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00022672
First received: August 10, 2001
Last updated: August 10, 2012
Last verified: August 2012
History of Changes
  Purpose

This 2 arm study will assess the safety and efficacy of adding intravenous Herceptin to daily oral anastrozole (Arimidex) tablets as first- and second-line treatment in postmenopausal patients with HER2 overexpressing metastatic breast cancer (ER+ve and/or PR+ve). Patients will be randomized to receive either anastrazole 1mg po daily,or anastrazole 1mg po daily + a loading dose of Herceptin 4mg/kg iv followed by weekly doses of Herceptin 2mg/kg iv. The anticipated time on study treatment is until disease progression, and the target sample size is 100-500 individuals.


Condition Intervention Phase
Breast Cancer
 Drug: trastuzumab [Herceptin]
Drug: Anastrazole
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomized, Open-label Study of the Effect of Herceptin Plus Arimidex Compared With Arimidex Alone on Progression-free Survival in Patients With HER2-positive and Hormone-receptor Positive Metastatic Breast Cancer

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Tumor measurements [ Time Frame: Event driven ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Hematology, serum chemistry, clinical safety assessments, cardiac monitoring. [ Time Frame: Throughout study ] [ Designated as safety issue: No ]

Enrollment: 208
Study Start Date: January 2001
Study Completion Date: October 2009
Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: trastuzumab [Herceptin]
4mg/kg iv loading dose, followed by 2mg/kg iv weekly
Drug: Anastrazole
1mg po daily
Active Comparator: 2 Drug: Anastrazole
1mg po daily

  Eligibility

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

Inclusion Criteria:

  • postmenopausal women;
  • metastatic breast cancer suitable for endocrine therapy;
  • positive hormone receptor status;
  • HER2 overexpression.

Exclusion Criteria:

  • patients on hormone replacement therapy;
  • previous chemotherapy for metastatic disease;
  • uncontrolled cardiac disease and history of cardiac failure.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00022672

  Show 132 Study Locations
Sponsors and Collaborators
Hoffmann-La Roche
Genentech
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00022672     History of Changes
Obsolete Identifiers: NCT00112450
Other Study ID Numbers: BO16216
Study First Received: August 10, 2001
Last Updated: August 10, 2012
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on May 22, 2013