Clinical trial NCT00022672: 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: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Breast Cancer
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
Collaborators: name: Genentech, Inc.
First posted: 2003-01-27
Enrollment: 208
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Progression Free Survival (PFS)
timeFrame: 24 Months, End of Study (Up to 5 years)
Secondary outcomes:
measure: Percentage of Participants With Clinical Benefit
timeFrame: 24 Months, End of Study (Up to 5 years)
measure: Duration of Response at 24 Months
timeFrame: 24 Months
measure: Time to Response at 24 Months
timeFrame: 24 Months
measure: Overall Survival at 24 Months
timeFrame: 24 Months
measure: Percentage of Participants With Two-Year Survival
timeFrame: 24 Months
measure: Percentage of Participants With Overall Tumor Response at 24 Months
timeFrame: 24 Months
measure: Percentage of Participants With Best Tumor Response at 24 Months
timeFrame: 24 Months
measure: Percentage of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status at Final Visit Compared to Baseline
timeFrame: Baseline, Final Visit (Up to 24 Months)
measure: Duration of Response at End of Study
timeFrame: End of Study (Up to 5 years)
measure: Time to Response at End of Study
timeFrame: End of Study (Up to 5 years)
measure: Percentage of Participants With Overall Tumor Response at End of Study
timeFrame: End of Study (Up to 5 years)
measure: Percentage of Participants With Best Tumor Response at End of Study
timeFrame: End of Study (Up to 5 years)
measure: Number of Participants With Adverse Events
timeFrame: Throughout the Study (Up to 5 years)
Other outcomes:
Locations:
city: Phoenix
country: United States
state: Arizona
city: Little Rock
country: United States
state: Arkansas
city: Los Angeles
country: United States
state: California
city: Vallejo
country: United States
state: California
city: Gainsville
country: United States
state: Florida
city: Miami
country: United States
state: Florida
city: Plantation
country: United States
state: Florida
city: Chicago
country: United States
state: Illinois
city: Chicago
country: United States
state: Illinois
city: Kansas City
country: United States
state: Kansas
city: Scarborough
country: United States
state: Maine
city: Detroit
country: United States
state: Michigan
city: Omaha
country: United States
state: Nebraska
city: Hackensack
country: United States
state: New Jersey
city: Albuquerque
country: United States
state: New Mexico
city: Santa Fe
country: United States
state: New Mexico
city: Rochester
country: United States
state: New York
city: Cincinnati
country: United States
state: Ohio
city: Cleveland
country: United States
state: Ohio
city: Hershey
country: United States
state: Pennsylvania
city: Box Hill
country: Australia
city: Darlinghurst
country: Australia
city: Waratah
country: Australia
city: Porto Alegre
country: Brazil
city: Plovdiv
country: Bulgaria
city: Sofia
country: Bulgaria
city: Stara Zagora
country: Bulgaria
city: Calgary
country: Canada
state: Alberta
city: Edmonton
country: Canada
state: Alberta
city: Victoria
country: Canada
state: British Columbia
city: Winnipeg
country: Canada
state: Manitoba
city: Oshawa
country: Canada
state: Ontario
city: Toronto
country: Canada
state: Ontario
city: Toronto
country: Canada
state: Ontario
city: Montreal
country: Canada
state: Quebec
city: Quebec City
country: Canada
state: Quebec
city: Beijing
country: China
city: Beijing
country: China
city: Shanghai
country: China
city: Shanghai
country: China
city: Wuhan
country: China
city: Avignon
country: France
city: Nice
country: France
city: Frankfurt
country: Germany
city: Kiel
country: Germany
city: München
country: Germany
city: Trier
country: Germany
city: Hong Kong
country: Hong Kong
city: Budapest
country: Hungary
city: Ahmedabad
country: India
city: Bangalore
country: India
city: Chennai
country: India
city: Cuttack
country: India
city: Ludhiana
country: India
city: Mumbai
country: India
city: New Delhi
country: India
city: New Delhi
country: India
city: New Delhi
country: India
city: Haifa
country: Israel
city: Haifa
country: Israel
city: Petach Tikva
country: Israel
city: Ramat-gan
country: Israel
city: Rehovot
country: Israel
city: Tel Aviv
country: Israel
city: Genova
country: Italy
city: Vilnius
country: Lithuania
city: Guadalajara
country: Mexico
city: Mexico City
country: Mexico
city: Amsterdam
country: Netherlands
city: Rotterdam
country: Netherlands
city: Trondheim
country: Norway
city: Bialystok
country: Poland
city: Bydgoszcz
country: Poland
city: Gliwice
country: Poland
city: Krakow
country: Poland
city: Lodz
country: Poland
city: Szczecin
country: Poland
city: Warszawa
country: Poland
city: Warszawa
country: Poland
city: Barnaul
country: Russian Federation
city: Izhevsk
country: Russian Federation
city: Kazan
country: Russian Federation
city: Krasnodar
country: Russian Federation
city: Moscow
country: Russian Federation
city: Moscow
country: Russian Federation
city: Moscow
country: Russian Federation
city: Moscow
country: Russian Federation
city: Moscow
country: Russian Federation
city: St Petersburg
country: Russian Federation
city: St Petersburg
country: Russian Federation
city: St Petersburg
country: Russian Federation
city: UFA
country: Russian Federation
city: Floracliffe
country: South Africa
city: Pretoria
country: South Africa
city: Barcelona
country: Spain
city: Córdoba
country: Spain
city: Girona
country: Spain
city: Madrid
country: Spain
city: Madrid
country: Spain
city: Madrid
country: Spain
city: Mataro
country: Spain
city: Reus
country: Spain
city: Valencia
country: Spain
city: Boras
country: Sweden
city: Gaelve
country: Sweden
city: Stockholm
country: Sweden
city: Örebro
country: Sweden
city: Taipei
country: Taiwan
city: Taoyuan
country: Taiwan
city: Ankara
country: Turkey
city: Ankara
country: Turkey
city: Istanbul
country: Turkey
city: Istanbul
country: Turkey
city: Izmir
country: Turkey
city: Shhiye, Ankara
country: Turkey
city: Kiev
country: Ukraine
city: Kiev
country: Ukraine
city: Lvov
country: Ukraine
city: Odessa
country: Ukraine
city: Sumy
country: Ukraine
city: Zaporozhye
country: Ukraine
city: Cardiff
country: United Kingdom
city: Edinburgh
country: United Kingdom
city: Guildford
country: United Kingdom
city: Ipswich
country: United Kingdom
city: London
country: United Kingdom
city: London
country: United Kingdom
city: Manchester
country: United Kingdom
city: Merseyside
country: United Kingdom
city: Newcastle Upon Tyne
country: United Kingdom
city: Southampton
country: United Kingdom
city: Swansea
country: United Kingdom
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: