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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00022672




Registration number
NCT00022672
Ethics application status
Date submitted
10/08/2001
Date registered
27/01/2003
Date last updated
13/06/2013

Titles & IDs
Public title
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
Scientific 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
Secondary ID [1] 0 0
BO16216
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Breast Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Breast

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - trastuzumab (Herceptin®)
Treatment: Drugs - anastrazole (Arimidex®)

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.

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.


Treatment: Drugs: trastuzumab (Herceptin®)
4mg/kg iv loading dose, followed by 2mg/kg iv weekly

Treatment: Drugs: anastrazole (Arimidex®)
1 mg tablet taken orally daily
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Progression Free Survival (PFS)
Timepoint [1] 0 0
24 Months, End of Study (Up to 5 years)
Secondary outcome [1] 0 0
Percentage of Participants With Clinical Benefit
Timepoint [1] 0 0
24 Months, End of Study (Up to 5 years)
Secondary outcome [2] 0 0
Duration of Response at 24 Months
Timepoint [2] 0 0
24 Months
Secondary outcome [3] 0 0
Time to Response at 24 Months
Timepoint [3] 0 0
24 Months
Secondary outcome [4] 0 0
Overall Survival at 24 Months
Timepoint [4] 0 0
24 Months
Secondary outcome [5] 0 0
Percentage of Participants With Two-Year Survival
Timepoint [5] 0 0
24 Months
Secondary outcome [6] 0 0
Percentage of Participants With Overall Tumor Response at 24 Months
Timepoint [6] 0 0
24 Months
Secondary outcome [7] 0 0
Percentage of Participants With Best Tumor Response at 24 Months
Timepoint [7] 0 0
24 Months
Secondary outcome [8] 0 0
Percentage of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status at Final Visit Compared to Baseline
Timepoint [8] 0 0
Baseline, Final Visit (Up to 24 Months)
Secondary outcome [9] 0 0
Duration of Response at End of Study
Timepoint [9] 0 0
End of Study (Up to 5 years)
Secondary outcome [10] 0 0
Time to Response at End of Study
Timepoint [10] 0 0
End of Study (Up to 5 years)
Secondary outcome [11] 0 0
Percentage of Participants With Overall Tumor Response at End of Study
Timepoint [11] 0 0
End of Study (Up to 5 years)
Secondary outcome [12] 0 0
Percentage of Participants With Best Tumor Response at End of Study
Timepoint [12] 0 0
End of Study (Up to 5 years)
Secondary outcome [13] 0 0
Number of Participants With Adverse Events
Timepoint [13] 0 0
Throughout the Study (Up to 5 years)

Eligibility
Key inclusion criteria
* postmenopausal women;
* metastatic breast cancer suitable for endocrine therapy;
* positive hormone receptor status;
* Human epidermal growth factor receptor 2 (HER2) overexpression.
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
* patients on hormone replacement therapy;
* previous chemotherapy for metastatic disease;
* uncontrolled cardiac disease and history of cardiac failure.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/01/2001
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/10/2009
Sample size
Target
Accrual to date
Final
208
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
- Box Hill
Recruitment hospital [2] 0 0
- Darlinghurst
Recruitment hospital [3] 0 0
- Waratah
Recruitment postcode(s) [1] 0 0
3128 - Box Hill
Recruitment postcode(s) [2] 0 0
2010 - Darlinghurst
Recruitment postcode(s) [3] 0 0
2298 - Waratah
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
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United States of America
State/province [2] 0 0
Arkansas
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United States of America
State/province [3] 0 0
California
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Florida
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Illinois
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United States of America
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Kansas
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United States of America
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Maine
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United States of America
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Michigan
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United States of America
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Nebraska
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United States of America
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New Jersey
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United States of America
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New Mexico
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United States of America
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New York
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United States of America
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Ohio
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United States of America
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Pennsylvania
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Brazil
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Porto Alegre
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Bulgaria
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Plovdiv
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Bulgaria
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Sofia
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Bulgaria
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Stara Zagora
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Canada
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Alberta
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British Columbia
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Canada
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Manitoba
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Ontario
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Beijing
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China
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Wuhan
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Avignon
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France
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Nice
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Germany
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Frankfurt
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Germany
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Kiel
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Germany
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München
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Germany
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Trier
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Hong Kong
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Hong Kong
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Hungary
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Budapest
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India
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Ahmedabad
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India
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Bangalore
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India
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Chennai
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India
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Cuttack
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India
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Ludhiana
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Mumbai
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India
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New Delhi
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Israel
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Haifa
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Israel
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Petach Tikva
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Ramat-gan
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Rehovot
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Barnaul
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Krasnodar
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UFA
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Floracliffe
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Pretoria
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Barcelona
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Córdoba
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Madrid
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Mataro
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Reus
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Valencia
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Sweden
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Boras
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Gaelve
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Stockholm
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Örebro
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Taipei
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Taoyuan
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Turkey
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Ankara
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Istanbul
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Izmir
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Shhiye, Ankara
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Ukraine
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Kiev
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Ukraine
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Lvov
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Odessa
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Ukraine
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Sumy
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Ukraine
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Zaporozhye
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United Kingdom
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Cardiff
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Edinburgh
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Guildford
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Ipswich
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London
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United Kingdom
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Manchester
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United Kingdom
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Merseyside
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United Kingdom
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Newcastle Upon Tyne
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United Kingdom
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Southampton
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United Kingdom
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Swansea

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Hoffmann-La Roche
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Genentech, Inc.
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Clinical Trials
Address 0 0
Hoffmann-La Roche
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/study/NCT00022672