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Breast CancerPhase 3NCT00022672

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

A Phase 3 study testing trastuzumab (Herceptin®) and anastrazole (Arimidex®) in people with Breast Cancer, run by Hoffmann-La Roche at 132 sites in 26 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Breast Cancer
What is being tested?
trastuzumab (Herceptin®) and anastrazole (Arimidex®)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
208 participants
Where
132 sitesin 26 countries
Study dates
Jan 2001to Oct 2009
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

132 sites in 26 countries.

132 sites in 26 countries

United States20 sites

  • Study site

    Albuquerque, New Mexico, 87131-5636

  • Study site

    Chicago, Illinois, 60612

  • Study site

    Chicago, Illinois, 60637

  • Study site

    Cincinnati, Ohio, 45267-0562

  • Study site

    Cleveland, Ohio, 44106

  • Study site

    Detroit, Michigan, 48202-2689

  • Study site

    Gainsville, Florida, 32605

  • Study site

    Hackensack, New Jersey, 07601

  • Study site

    Hershey, Pennsylvania, 17033-0850

  • Study site

    Kansas City, Kansas, 66160

  • Study site

    Little Rock, Arkansas, 72205-7199

  • Study site

    Los Angeles, California, 90048

  • Study site

    Miami, Florida, 33176

  • Study site

    Omaha, Nebraska, 68114

  • Study site

    Phoenix, Arizona, 85006

  • Study site

    Plantation, Florida, 33324

  • Study site

    Rochester, New York, 14642

  • Study site

    Santa Fe, New Mexico, 87505

  • Study site

    Scarborough, Maine, 04074

  • Study site

    Vallejo, California, 94589

Other trials in United States

Russia13 sites

  • Study site

    Barnaul, 656049

  • Study site

    Izhevsk, 426009

  • Study site

    Kazan', 420029

  • Study site

    Krasnodar, 350080

  • Study site

    Moscow, 107005

  • Study site

    Moscow, 115478

  • Study site

    Moscow, 117837

  • Study site

    Moscow, 121356

  • Study site

    Moscow, 125284

  • Study site

    Saint Petersburg, 189646

  • Study site

    Saint Petersburg, 197022

  • Study site

    Saint Petersburg, 197758

  • Study site

    Ufa, 450054

Other trials in Russia

United Kingdom11 sites

  • Study site

    Cardiff, CF14 2TL

  • Study site

    Edinburgh, EH4 2XU

  • Study site

    Guildford, GU2 7XX

  • Study site

    Ipswich, IP4 5PD

  • Study site

    London, NW3 2QG

  • Study site

    London, SE1 9RT

  • Study site

    Manchester, M20 4BX

  • Study site

    Merseyside, CH63 45Y

  • Study site

    Newcastle upon Tyne, NE4 6BE

  • Study site

    Southampton, SO16 6YD

  • Study site

    Swansea, SA2 8QA

Other trials in United Kingdom

Canada9 sites

  • Study site

    Calgary, Alberta, T2N 4N2

  • Study site

    Edmonton, Alberta, T6G 1Z2

  • Study site

    Montreal, Quebec, H1T 2M4

  • Study site

    Oshawa, Ontario, L1G 2B9

  • Study site

    Québec, Quebec, G1S 4L8

  • Study site

    Toronto, Ontario, M4N 3M5

  • Study site

    Toronto, Ontario, M5G 2M9

  • Study site

    Victoria, British Columbia, V8R 6V5

  • Study site

    Winnipeg, Manitoba, R3E 0V9

Other trials in Canada

India9 sites

  • Study site

    Ahmedabad, 380 016

  • Study site

    Bangalore, 560 029

  • Study site

    Chennai, 600 020

  • Study site

    Cuttack, 753 007

  • Study site

    Ludhiana, 141 001

  • Study site

    Mumbai, 400012

  • Study site

    New Delhi, 110 029

  • Study site

    New Delhi, 110 060

  • Study site

    New Delhi, 110085

Other trials in India

Spain9 sites

  • Study site

    Barcelona, 08036

  • Study site

    Córdoba, 14004

  • Study site

    Girona, 17007

  • Study site

    Madrid, 28007

  • Study site

    Madrid, 28034

  • Study site

    Madrid, 28041

  • Study site

    Mataró, 08304

  • Study site

    Reus, 43204

  • Study site

    Valencia, 46009

Other trials in Spain

Poland8 sites

  • Study site

    Bialystok, 15-027

  • Study site

    Bydgoszcz, 85-796

  • Study site

    Gliwice, 44-101

  • Study site

    Krakow, 31-115

  • Study site

    Lodz, 94-306

  • Study site

    Szczecin, 71-730

  • Study site

    Warsaw, 00-909

  • Study site

    Warsaw, 02-781

Other trials in Poland

Israel6 sites

  • Study site

    Haifa, 31096

  • Study site

    Haifa, 34362

  • Study site

    Petah Tikva, 49100

  • Study site

    Ramat Gan, 52621

  • Study site

    Rehovot, 76100

  • Study site

    Tel Aviv, 64239

Other trials in Israel

Turkey (Türkiye)6 sites

  • Study site

    Ankara, 06230

  • Study site

    Ankara, 06500

  • Study site

    Istanbul, 34300

  • Study site

    Istanbul, 34390

  • Study site

    Izmir, 35100

  • Study site

    Shhiye, Ankara, 06100

Other trials in Turkey (Türkiye)

Ukraine6 sites

  • Study site

    Kiev, 03022

  • Study site

    Kiev

  • Study site

    Lviv, 79031

  • Study site

    Odesa, 65055

  • Study site

    Sumy, 40005

  • Study site

    Zaporizhzhya, 69104

Other trials in Ukraine

China5 sites

  • Study site

    Beijing, 100021

  • Study site

    Beijing, 100071

  • Study site

    Shanghai, 200025

  • Study site

    Shanghai, 200032

  • Study site

    Wuhan, 430030

Other trials in China

Germany4 sites

  • Study site

    Frankfurt, 60596

  • Study site

    Kiel, 24105

  • Study site

    München, 80637

  • Study site

    Trier, 54290

Other trials in Germany

Sweden4 sites

  • Study site

    Borås, 50182

  • Study site

    Gaelve, 80187

  • Study site

    Örebro, 701 85

  • Study site

    Stockholm, 17176

Other trials in Sweden

Australia3 sites

  • Study site

    Box Hill, 3128

  • Study site

    Darlinghurst, 2010

  • Study site

    Waratah, 2298

Other trials in Australia

Bulgaria3 sites

  • Study site

    Plovdiv, 4000

  • Study site

    Sofia, 1527

  • Study site

    Stara Zagora, 8000

Other trials in Bulgaria

France2 sites

  • Study site

    Avignon, 84082

  • Study site

    Nice, 06189

Other trials in France

Mexico2 sites

  • Study site

    Guadalajara, 44340

  • Study site

    Mexico City, 14000

Other trials in Mexico

Netherlands2 sites

  • Study site

    Amsterdam, 1081 HV

  • Study site

    Rotterdam, 3075 EA

Other trials in Netherlands

South Africa2 sites

  • Study site

    Floracliffe, 1715

  • Study site

    Pretoria

Other trials in South Africa

Taiwan2 sites

  • Study site

    Taipei, 112

  • Study site

    Taoyuan, 333

Other trials in Taiwan

Brazil1 site

  • Study site

    Porto Alegre, 90610-000

Other trials in Brazil

Hong Kong1 site

  • Study site

    Hong Kong

Other trials in Hong Kong

Hungary1 site

  • Study site

    Budapest, H-1122

Other trials in Hungary

Italy1 site

  • Study site

    Genova, 16132

Other trials in Italy

Lithuania1 site

  • Study site

    Vilnius, 2600

Other trials in Lithuania

Norway1 site

  • Study site

    Trondheim, 7006

Other trials in Norway

About this study

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

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
Being tested
trastuzumab (Herceptin®), anastrazole (Arimidex®)
Medical subject headings
Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • trastuzumab (Herceptin®)Drug

    Also called Herceptin®

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

  • anastrazole (Arimidex®)Drug

    Also called Arimidex®

    1 mg tablet taken orally daily

Study groups in NCT00022672
Study groupRoleWhat they receive
trastuzumab + anastrozoleExperimentalTrastuzumab 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.
Receives: Drug: trastuzumab (Herceptin®); Drug: anastrazole (Arimidex®)
anastrozoleActive comparator1 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.
Receives: Drug: anastrazole (Arimidex®)

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

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

Secondary outcomes (13)

  1. Percentage of Participants With Clinical Benefit

    Clinical Benefit was defined as stable disease for ≥ six months or complete response or partial response.

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

  2. Duration of Response at 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.

    Measured: 24 Months

  3. Time to Response at 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.

    Measured: 24 Months

  4. Overall Survival at 24 Months

    Overall Survival is defined as the number of days from randomization to death.

    Measured: 24 Months

  5. Percentage of Participants With Two-Year Survival

    Measured: 24 Months

  6. Percentage of Participants With Overall Tumor Response at 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.

    Measured: 24 Months

  7. Percentage of Participants With Best Tumor Response at 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.

    Measured: 24 Months

  8. Percentage of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status at Final Visit Compared to Baseline

    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.

    Measured: Baseline, Final Visit (Up to 24 Months)

  9. Duration of Response at End of Study

    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.

    Measured: End of Study (Up to 5 years)

  10. Time to Response at End of Study

    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.

    Measured: End of Study (Up to 5 years)

  11. Percentage of Participants With Overall Tumor Response at End of Study

    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.

    Measured: End of Study (Up to 5 years)

  12. Percentage of Participants With Best Tumor Response at End of Study

    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.

    Measured: End of Study (Up to 5 years)

  13. Number of Participants With Adverse Events

    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.

    Measured: Throughout the Study (Up to 5 years)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jan 2003 (estimated)
  2. Study startJan 2001
  3. Primary completionOct 2009
  4. Study completionOct 2009

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
208 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00022672
Sponsor's protocol ID
BO16216
Status last verified
Jun 2013
First submitted
10 Aug 2001
Last updated
13 Jun 2013

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing trastuzumab (Herceptin®) and anastrazole (Arimidex®) in people with Breast Cancer, run by Hoffmann-La Roche at 132 sites in 26 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Jun 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 132 sites in United States, Russia, United Kingdom, Canada, India and 21 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 13 Jun 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression Free Survival (PFS) (time frame: 24 Months, End of Study (Up to 5 years)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00022672.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jun 2013.

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