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Trial record 21 of 199 for:    Oral Cancer | ( Map: Mexico )

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00022672
Recruitment Status : Completed
First Posted : January 27, 2003
Results First Posted : June 13, 2013
Last Update Posted : June 13, 2013
Sponsor:
Collaborator:
Genentech, Inc.
Information provided by (Responsible Party):
Hoffmann-La Roche

Tracking Information
First Submitted Date  ICMJE August 10, 2001
First Posted Date  ICMJE January 27, 2003
Results First Submitted Date  ICMJE April 2, 2013
Results First Posted Date  ICMJE June 13, 2013
Last Update Posted Date June 13, 2013
Study Start Date  ICMJE January 2001
Actual Primary Completion Date October 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 7, 2013)
Progression Free Survival (PFS) [ Time Frame: 24 Months, End of Study (Up to 5 years) ]
PFS was assessed by the investigator based on World Health Organization (WHO) criteria using radiographic tumor evaluations. Disease progression was defined as the appearance of any new lesion not previously identified or an estimated increase of 25% or more in existent bidimensionally or unidimensionally measurable lesions or progression of an existing non-measurable lesion. For bidimensionally measurable malignant lesions with an area of at least 2.0 centimeters squared (cm^2) an increase of 1.0 cm^2 was required and for unidimensionally measurable lesions of 1.0 cm or less an increase of 0.5 cm was required. PFS was defined as the number of days between date of randomization and date of documented disease progression or date of death. Kaplan Meier estimates of PFS are presented.
Original Primary Outcome Measures  ICMJE Not Provided
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 7, 2013)
  • Percentage of Participants With Clinical Benefit [ Time Frame: 24 Months, End of Study (Up to 5 years) ]
    Clinical Benefit was defined as stable disease for ≥ six months or complete response or partial response.
  • Duration of Response at 24 Months [ Time Frame: 24 Months ]
    Duration of response was defined as the number of days from the day complete response or partial response was first noted to the day of progression of disease, death or last follow-up.
  • Time to Response at 24 Months [ Time Frame: 24 Months ]
    Time to response was defined as the number of days from the day of randomization to the day complete response or partial response was first noted.
  • Overall Survival at 24 Months [ Time Frame: 24 Months ]
    Overall Survival is defined as the number of days from randomization to death.
  • Percentage of Participants With Two-Year Survival [ Time Frame: 24 Months ]
  • Percentage of Participants With Overall Tumor Response at 24 Months [ Time Frame: 24 Months ]
    Tumor Response levels were determined by the investigator and an Independent Response Evaluation Committee and Reconciled. Overall Response was defined as either complete response or partial response.
  • Percentage of Participants With Best Tumor Response at 24 Months [ Time Frame: 24 Months ]
    Tumor Response levels were determined by the investigator and an Independent Response Evaluation Committee and Reconciled. Best Response was defined as the best response a patient achieves in the study.
  • Percentage of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status at Final Visit Compared to Baseline [ Time Frame: Baseline, Final Visit (Up to 24 Months) ]
    Participants rated their performance status using the ECOG Questionnaire on the following scale: 0=Fully active, perform all pre-disease activities without restriction; 1=Restricted in physically strenuous activity but ambulatory, carry out work of a light or sedentary nature; 2=Ambulatory, capable of self-care, unable to carry out any work activities, up and about more than >50% of waking hours; 3=Capable of limited self-care, confined to bed or chair >50% of waking hours; 4=Completely disabled, not capable of any self-care, totally confined to bed or chair; 5=Dead. The percentage of participants in the following categories: Improved: Score decrease from baseline. Unchanged: Score the same as baseline. Worse: Score increase from baseline.
  • Duration of Response at End of Study [ Time Frame: End of Study (Up to 5 years) ]
    Duration of response was defined as the number of days from the day complete response or partial response was first noted to the day of progression of disease, death or last follow-up.
  • Time to Response at End of Study [ Time Frame: End of Study (Up to 5 years) ]
    Time to response was defined as the number of days from the day of randomization to the day complete response or partial response was first noted.
  • Percentage of Participants With Overall Tumor Response at End of Study [ Time Frame: End of Study (Up to 5 years) ]
    Tumor Response levels were determined by the investigator and an Independent Response Evaluation Committee and Reconciled. Overall Response was defined as either complete response or partial response.
  • Percentage of Participants With Best Tumor Response at End of Study [ Time Frame: End of Study (Up to 5 years) ]
    Tumor Response levels were determined by the investigator and an Independent Response Evaluation Committee and Reconciled. Best Response was defined as the best response a patient achieves in the study.
  • Number of Participants With Adverse Events [ Time Frame: Throughout the Study (Up to 5 years) ]
    Number of participants with adverse events as a measure for safety as assessed by the collection of adverse events, laboratory tests for Hematology and Serum Chemistry, clinical assessments and cardiac monitoring.
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study to Evaluate the Efficacy and Safety of Herceptin® (Trastuzumab) in Combination With Arimidex® (Anastrozole) an Aromatase Inhibitor Compared to Arimidex® Alone in Patients With Metastatic Breast Cancer
Official Title  ICMJE 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
Brief Summary This 2 arm study assessed the safety and efficacy of adding intravenous trastuzumab (Herceptin®) to daily oral anastrozole (Arimidex®) tablets as first- and second-line treatment in postmenopausal patients with human epidermal growth factor receptor-2 (HER2) overexpressing metastatic breast cancer (ER+ve and/or PR+ve). Patients were randomized to receive either anastrazole 1 mg per os (po) daily, or anastrazole 1 mg po daily + a loading dose of Herceptin® 4 mg/kg intravenous (iv) followed by weekly doses of Herceptin® 2 mg/kg iv. The anticipated time on study treatment was until disease progression, and the target sample size was 100-500 individuals.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Breast Cancer
Intervention  ICMJE
  • Drug: trastuzumab (Herceptin®)
    4mg/kg iv loading dose, followed by 2mg/kg iv weekly
    Other Name: Herceptin®
  • Drug: anastrazole (Arimidex®)
    1 mg tablet taken orally daily
    Other Name: Arimidex®
Study Arms  ICMJE
  • Experimental: trastuzumab + anastrozole
    Trastuzumab 4 mg/kg loading dose intravenous (iv) over 90 minutes, followed by weekly doses of 2 mg/kg iv over 30 minutes plus 1 mg oral dose of anastrozole every day for 24 Months in the Main phase and in the Extension Phase.
    Interventions:
    • Drug: trastuzumab (Herceptin®)
    • Drug: anastrazole (Arimidex®)
  • Active Comparator: anastrozole
    1 mg oral dose of anastrozole every day for 24 Months in the Main phase. In the Extension Phase participants could cross-over to also receive trastuzumab 4 mg/kg initial loading dose intravenous (iv) over 90 minutes, followed by weekly doses of 2 mg/kg iv over 30 minutes.
    Intervention: Drug: anastrazole (Arimidex®)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 10, 2012)
208
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE October 2009
Actual Primary Completion Date October 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • postmenopausal women;
  • metastatic breast cancer suitable for endocrine therapy;
  • positive hormone receptor status;
  • Human epidermal growth factor receptor 2 (HER2) overexpression.

Exclusion Criteria:

  • patients on hormone replacement therapy;
  • previous chemotherapy for metastatic disease;
  • uncontrolled cardiac disease and history of cardiac failure.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Mexico,   Australia,   Brazil,   Bulgaria,   Canada,   China,   France,   Germany,   Hong Kong,   Hungary,   India,   Israel,   Italy,   Lithuania,   Netherlands,   Norway,   Poland,   Russian Federation,   South Africa,   Spain,   Sweden,   Taiwan,   Turkey,   Ukraine,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00022672
Other Study ID Numbers  ICMJE BO16216
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Hoffmann-La Roche
Study Sponsor  ICMJE Hoffmann-La Roche
Collaborators  ICMJE Genentech, Inc.
Investigators  ICMJE
Study Director: Clinical Trials Hoffmann-La Roche
PRS Account Hoffmann-La Roche
Verification Date June 2013

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