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

NCT00022672 | Completed Phase 3 Results

• 1 other identifier: BO16216
• Study Type: interventional
• Target: 208
• Locations: 26 countries
• Sites: 132

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.

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

• Progression Free Survival (PFS)

  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.

  24 Months, End of Study (Up to 5 years)

Secondary Outcomes (13)

• Percentage of Participants With Clinical Benefit

  24 Months, End of Study (Up to 5 years)

• Duration of Response at 24 Months

  24 Months

• Time to Response at 24 Months

  24 Months

• Overall Survival at 24 Months

  24 Months

• Percentage of Participants With Two-Year Survival

  24 Months

Study Arms (2)

trastuzumab + anastrozole

EXPERIMENTAL

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.

Drug: trastuzumab (Herceptin®); Drug: anastrazole (Arimidex®)

anastrozole

ACTIVE COMPARATOR

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.

Drug: anastrazole (Arimidex®)

Interventions

trastuzumab (Herceptin®) DRUG

4mg/kg iv loading dose, followed by 2mg/kg iv weekly

Also known as: Herceptin®

trastuzumab + anastrozole

anastrazole (Arimidex®) DRUG

1 mg tablet taken orally daily

Also known as: Arimidex®

anastrozole; trastuzumab + anastrozole

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• patients on hormone replacement therapy;
• previous chemotherapy for metastatic disease;
• uncontrolled cardiac disease and history of cardiac failure.

Sponsors & Collaborators

• Hoffmann-La Roche: lead
• Genentech, Inc.: collaborator

Study Sites (132)

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Phoenix, Arizona, 85006, United States

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Little Rock, Arkansas, 72205-7199, United States

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Los Angeles, California, 90048, United States

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Vallejo, California, 94589, United States

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Gainsville, Florida, 32605, United States

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Miami, Florida, 33176, United States

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Plantation, Florida, 33324, United States

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Chicago, Illinois, 60612, United States

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Chicago, Illinois, 60637, United States

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Kansas City, Kansas, 66160, United States

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Scarborough, Maine, 04074, United States

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Detroit, Michigan, 48202-2689, United States

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Omaha, Nebraska, 68114, United States

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Hackensack, New Jersey, 07601, United States

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Albuquerque, New Mexico, 87131-5636, United States

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Santa Fe, New Mexico, 87505, United States

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Rochester, New York, 14642, United States

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Cincinnati, Ohio, 45267-0562, United States

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Cleveland, Ohio, 44106, United States

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Hershey, Pennsylvania, 17033-0850, United States

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Box Hill, 3128, Australia

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Darlinghurst, 2010, Australia

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Waratah, 2298, Australia

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Porto Alegre, 90610-000, Brazil

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Plovdiv, 4000, Bulgaria

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Sofia, 1527, Bulgaria

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Stara Zagora, 8000, Bulgaria

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Calgary, Alberta, T2N 4N2, Canada

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Edmonton, Alberta, T6G 1Z2, Canada

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Victoria, British Columbia, V8R 6V5, Canada

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Winnipeg, Manitoba, R3E 0V9, Canada

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Oshawa, Ontario, L1G 2B9, Canada

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Toronto, Ontario, M4N 3M5, Canada

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Toronto, Ontario, M5G 2M9, Canada

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Montreal, Quebec, H1T 2M4, Canada

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Québec, Quebec, G1S 4L8, Canada

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Beijing, 100021, China

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Beijing, 100071, China

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Shanghai, 200025, China

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Shanghai, 200032, China

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Wuhan, 430030, China

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Avignon, 84082, France

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Nice, 06189, France

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Frankfurt, 60596, Germany

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Kiel, 24105, Germany

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München, 80637, Germany

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Trier, 54290, Germany

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Hong Kong, Hong Kong

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Budapest, H-1122, Hungary

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Ahmedabad, 380 016, India

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Bangalore, 560 029, India

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Chennai, 600 020, India

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Cuttack, 753 007, India

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Ludhiana, 141 001, India

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Mumbai, 400012, India

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New Delhi, 110 029, India

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New Delhi, 110 060, India

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New Delhi, 110085, India

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Haifa, 31096, Israel

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Haifa, 34362, Israel

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Petah Tikva, 49100, Israel

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Ramat Gan, 52621, Israel

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Rehovot, 76100, Israel

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Tel Aviv, 64239, Israel

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Genova, 16132, Italy

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Vilnius, 2600, Lithuania

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Guadalajara, 44340, Mexico

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Mexico City, 14000, Mexico

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Amsterdam, 1081 HV, Netherlands

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Rotterdam, 3075 EA, Netherlands

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Trondheim, 7006, Norway

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Bialystok, 15-027, Poland

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Bydgoszcz, 85-796, Poland

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Gliwice, 44-101, Poland

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Krakow, 31-115, Poland

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Lodz, 94-306, Poland

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Szczecin, 71-730, Poland

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Warsaw, 00-909, Poland

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Warsaw, 02-781, Poland

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Barnaul, 656049, Russia

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Izhevsk, 426009, Russia

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Kazan', 420029, Russia

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Krasnodar, 350080, Russia

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Moscow, 107005, Russia

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Moscow, 115478, Russia

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Moscow, 117837, Russia

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Moscow, 121356, Russia

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Moscow, 125284, Russia

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Saint Petersburg, 189646, Russia

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Saint Petersburg, 197022, Russia

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Saint Petersburg, 197758, Russia

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Ufa, 450054, Russia

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Floracliffe, 1715, South Africa

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Pretoria, South Africa

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Barcelona, 08036, Spain

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Córdoba, 14004, Spain

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Girona, 17007, Spain

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Madrid, 28007, Spain

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Madrid, 28034, Spain

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Madrid, 28041, Spain

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Mataró, 08304, Spain

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Reus, 43204, Spain

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Valencia, 46009, Spain

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Borås, 50182, Sweden

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Gaelve, 80187, Sweden

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Örebro, 701 85, Sweden

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Stockholm, 17176, Sweden

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Taipei, 112, Taiwan

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Taoyuan District, 333, Taiwan

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Ankara, 06230, Turkey (Türkiye)

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Ankara, 06500, Turkey (Türkiye)

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Istanbul, 34300, Turkey (Türkiye)

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Istanbul, 34390, Turkey (Türkiye)

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Izmir, 35100, Turkey (Türkiye)

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Shhiye, Ankara, 06100, Turkey (Türkiye)

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Kiev, 03022, Ukraine

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Kiev, Ukraine

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Lviv, 79031, Ukraine

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Odesa, 65055, Ukraine

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Sumy, 40005, Ukraine

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Zaporizhzhya, 69104, Ukraine

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Cardiff, CF14 2TL, United Kingdom

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Edinburgh, EH4 2XU, United Kingdom

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Guildford, GU2 7XX, United Kingdom

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Ipswich, IP4 5PD, United Kingdom

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London, NW3 2QG, United Kingdom

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London, SE1 9RT, United Kingdom

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Manchester, M20 4BX, United Kingdom

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Merseyside, CH63 45Y, United Kingdom

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Newcastle upon Tyne, NE4 6BE, United Kingdom

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Southampton, SO16 6YD, United Kingdom

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Swansea, SA2 8QA, United Kingdom

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MeSH Terms

Conditions

Breast Neoplasms

Interventions

Trastuzumab; Anastrozole

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Nitriles; Organic Chemicals; Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Medical Communications
• Organization: Hoffman-LaRoche

800-821-8590

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 10, 2001
• First Posted: January 27, 2003
• Study Start: January 1, 2001
• Primary Completion: October 1, 2009
• Study Completion: October 1, 2009
• Last Updated: June 13, 2013
• Results First Posted: June 13, 2013

Record last verified: 2013-06

Locations

IN (9); CA (9); CN (5); AU (3); ES (9); BR (1); HK (1); DE (4); IT (1); ME (2); NO (1); NL (2); US (20); RU (13); FR (2); LI (1); TW (2); TU (6); HU (1); BU (3); ZA (2); PL (8); SE (4); GB (11); UA (6); IL (6)