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Breast CancerPhase 3NCT00333775

A Study of Bevacizumab (Avastin) in Women With HER2 Negative Metastatic Breast Cancer

A Phase 3 study testing Docetaxel and Bevacizumab in people with Breast Cancer, run by Hoffmann-La Roche at 114 sites in 24 countries.

Completed

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

Official record
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Trial summary

This study will evaluate the efficacy and safety of 2 doses of Avastin in combination with docetaxel, versus docetaxel plus placebo, in patients with metastatic HER2 negative breast cancer who are candidates for taxane-based chemotherapy but who have not received prior chemotherapy for metastatic disease. 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?
Docetaxel and Bevacizumab
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
736 participants
Where
114 sitesin 24 countries
Study dates
Mar 2006to Oct 2013
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

  • Female patients ≥ 18 years of age.
  • Human epidermal growth factor receptor 2 (HER2)-negative cancer of the breast with locally recurrent or metastatic disease, suitable for chemotherapy.
  • No adjuvant chemotherapy within 6 months before randomization, and no taxane-based chemotherapy within 12 months before randomization.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.

Who cannot join

  • Previous chemotherapy for metastatic or locally recurrent breast cancer.
  • Radiotherapy for treatment of metastatic disease.
  • Other primary tumors within last 5 years, except for controlled limited basal cell or squamous cancer of the skin, or cancer in situ of the cervix.
  • Spinal cord compression or brain metastases.
  • Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to randomization.
  • Inadequate bone marrow, liver, or renal function.
  • Uncontrolled hypertension.

Trial locations and contacts

114 sites in 24 countries.

114 sites in 24 countries

Germany16 sites

  • Study site

    Ansbach, 91522

  • Study site

    Berlin, 14195

  • Study site

    Düsseldorf, 40225

  • Study site

    Erlangen, 91054

  • Study site

    Frankfurt, 60596

  • Study site

    Frankfurt am Main, 60389

  • Study site

    Halle, 06120

  • Study site

    Hamburg, 20246

  • Study site

    Heidelberg, 69120

  • Study site

    Jena, 07743

  • Study site

    Lemgo, 32657

  • Study site

    München, 81675

  • Study site

    Stuttgart, 70376

  • Study site

    Trier, 54290

  • Study site

    Tübingen, 72076

  • Study site

    Ulm, 89075

Other trials in Germany

United Kingdom10 sites

  • Study site

    Bournemouth, BH7 7DW

  • Study site

    Cambridge, CB2 2QQ

  • Study site

    Edinburgh, EH4 2XU

  • Study site

    Leeds, LS16 5WW

  • Study site

    Leeds, LS9 7TF

  • Study site

    London, SE1 7EH

  • Study site

    Manchester, M20 4BX

  • Study site

    Middlesex, HA6 2RN

  • Study site

    Newcastle upon Tyne, NE7 7DN

  • Study site

    Truro, TR1 3LJ

Other trials in United Kingdom

Canada9 sites

  • Study site

    Calgary, Alberta, T2N 4N2

  • Study site

    Edmonton, Alberta, T6G 1Z2

  • Study site

    Greater Sudbury, Ontario, P3E 5J1

  • Study site

    Halifax, Nova Scotia, B3H 1V7

  • Study site

    Montreal, Quebec, H4J 1C5

  • Study site

    Ottawa, Ontario, K1H 8L6

  • Study site

    Québec, Quebec, G1S 4L8

  • Study site

    Toronto, Ontario, M4N 3M5

  • Study site

    Vancouver, British Columbia, V5Z 4E6

Other trials in Canada

Italy9 sites

  • Study site

    Biella, Piedmont, 13900

  • Study site

    Bologna, Emilia-Romagna, 40138

  • Study site

    Modena, Emilia-Romagna, 41100

  • Study site

    Parma, Emilia-Romagna, 43100

  • Study site

    Province of Macerata, The Marches, 62100

  • Study site

    Taormina, Sicily, 98030

  • Study site

    Treviglio, Lombardy, 24047

  • Study site

    Trieste, Friuli Venezia Giulia, 34100

  • Study site

    Udine, Friuli Venezia Giulia, 33100

Other trials in Italy

Australia8 sites

  • Study site

    Adelaide, New South Wales, 5011

  • Study site

    Auchenflower, Queensland, 4066

  • Study site

    Box Hill, Victoria, 3128

  • Study site

    Camperdown, New South Wales, 2050

  • Study site

    Fitzroy, Victoria, 3065

  • Study site

    Perth, Western Australia, 6000

  • Study site

    Ringwood East, Victoria, 3135

  • Study site

    Westmead, New South Wales, 2145

Other trials in Australia

France8 sites

  • Study site

    Besançon, 25030

  • Study site

    Bordeaux, 33076

  • Study site

    Caen, 14076

  • Study site

    Clermont-Ferrand, 63011

  • Study site

    Dijon, 21079

  • Study site

    Lille, 59020

  • Study site

    Montpellier, 34298

  • Study site

    Villejuif, 94805

Other trials in France

Spain7 sites

  • Study site

    Barcelona, Barcelona, 08003

  • Study site

    Barcelona, Barcelona, 08035

  • Study site

    Barcelona, Barcelona, 08036

  • Study site

    Barcelona, Barcelona, 08907

  • Study site

    Jaén, Jaen, 23007

  • Study site

    Madrid, Madrid, 28041

  • Study site

    Málaga, Malaga, 29010

Other trials in Spain

Brazil6 sites

  • Study site

    Barretos, São Paulo, 14784-400

  • Study site

    Belo Horizonte, Minas Gerais, 31190-131

  • Study site

    Florianópolis, Santa Catarina, 88034-000

  • Study site

    Goiânia, Goiás, 74605-070

  • Study site

    Porto Alegre, Rio Grande do Sul, 90610-000

  • Study site

    São Paulo, São Paulo, 01509-010

Other trials in Brazil

Mexico6 sites

  • Study site

    Mérida, 97500

  • Study site

    Mexicali, 21100

  • Study site

    Mexico City, 06760

  • Study site

    Monterrey, 64380

  • Study site

    Obregón, 85000

  • Study site

    Puebla City, 72530

Other trials in Mexico

Poland5 sites

  • Study site

    Krakow, 31-826

  • Study site

    Olsztyn, 10-513

  • Study site

    Poznan, 60-569

  • Study site

    Warsaw, 02-781

  • Study site

    Wroclaw, 53-413

Other trials in Poland

Austria4 sites

  • Study site

    Graz, 8036

  • Study site

    Salzburg, 5020

  • Study site

    Vienna, 1090

  • Study site

    Vöcklabruck, 4840

Other trials in Austria

South Korea3 sites

  • Study site

    Seoul, 120-752

  • Study site

    Seoul, 135-710

  • Study site

    Seoul, 138-736

Other trials in South Korea

Sweden3 sites

  • Study site

    Linköping, 58185

  • Study site

    Lund, 22185

  • Study site

    Umeå, 90185

Other trials in Sweden

Taiwan3 sites

  • Study site

    Kaohsiung City, 813

  • Study site

    Taipei, 100

  • Study site

    Taipei, 114

Other trials in Taiwan

Thailand3 sites

  • Study site

    Bangkok, 10400

  • Study site

    Bangkok, 10700

  • Study site

    Khon Kaen, 40002

Other trials in Thailand

Belgium2 sites

  • Study site

    Brussels, 1000

  • Study site

    Wilrijk, 2610

Other trials in Belgium

Lithuania2 sites

  • Study site

    Kaunas, 50009

  • Study site

    Vilnius, 08660

Other trials in Lithuania

Netherlands2 sites

  • Study site

    Sittard, 6131 BK

  • Study site

    Utrecht, 3582 KE

Other trials in Netherlands

Portugal2 sites

  • Study site

    Coimbra, 3000-075

  • Study site

    Lisbon, 1099-023

Other trials in Portugal

South Africa2 sites

  • Study site

    Pretoria, 0002

  • Study site

    Sandton, 2196

Other trials in South Africa

China1 site

  • Study site

    Beijing, 100021

Other trials in China

Panama1 site

  • Study site

    Panama City, 83-0669

Other trials in Panama

Romania1 site

  • Study site

    Bucharest, 022328

Other trials in Romania

Switzerland1 site

  • Study site

    Chur, 7000

Other trials in Switzerland

About this study

Official title: A Randomised, Double Blind, Placebo Controlled, Multicentre Study to Evaluate the Efficacy and Safety of Bevacizumab in Combination With Docetaxel in Comparison With Docetaxel Plus Placebo, as First Line Treatment for Patients With HER2 Negative Metastatic and Locally Recurrent Breast Cancer.

This study will evaluate the efficacy and safety of 2 doses of Avastin in combination with docetaxel, versus docetaxel plus placebo, in patients with metastatic HER2 negative breast cancer who are candidates for taxane-based chemotherapy but who have not received prior chemotherapy for metastatic disease. The anticipated time on treatment is 1-2 years and the target sample size is 500+ individuals.

Read the detailed description

Five participants randomized to the docetaxel 100 mg/m^2 plus placebo group actually received docetaxel 100 mg/m^2 plus bevacizumab 7.5 mg/kg and are included in the docetaxel 100 mg/m^2 plus bevacizumab 7.5 mg/kg group for the adverse event results. Sixteen participants randomized to the docetaxel 100 mg/m^2 plus placebo group actually received docetaxel 100 mg/m^2 plus bevacizumab 15.0 mg/kg and are included in the docetaxel 100 mg/m^2 plus bevacizumab 15.0 mg/kg group for the adverse event results.

Conditions
Breast Cancer
Being tested
Docetaxel, Placebo to bevacizumab, Bevacizumab
Medical subject headings
Breast Neoplasms

What participants receive

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

  • DocetaxelDrug

    Docetaxel was supplied in 2 vials, 1 containing docetaxel and 1 containing a solvent, for intravenous infusion.

  • Placebo to bevacizumabDrug

    Placebo to bevacizumab was supplied as a sterile liquid for intravenous infusion in single-use vials.

  • BevacizumabDrug

    Also called Avastin

    Bevacizumab was supplied as a sterile liquid for intravenous infusion in single-use vials.

Study groups in NCT00333775
Study groupRoleWhat they receive
Docetaxel 100 mg/m^2 plus placeboExperimentalParticipants received docetaxel 100 mg/m^2 intravenously on Day 1 of each 3 week cycle for a maximum of 27 weeks (9 cycles). In addition, participants received placebo to bevacizumab intravenously on Day 1 of each 3 week cycle until disease progression, unacceptable toxicity, or participant withdrawal.
Receives: Drug: Docetaxel; Drug: Placebo to bevacizumab
Docetaxel 100 mg/m^2 plus bevacizumab 7.5 mg/kgExperimentalParticipants received docetaxel 100 mg/m^2 intravenously on Day 1 of each 3 week cycle for a maximum of 27 weeks (9 cycles). In addition, participants received bevacizumab 7.5 mg/kg intravenously on Day 1 of each 3 week cycle until disease progression, unacceptable toxicity, or participant withdrawal.
Receives: Drug: Docetaxel; Drug: Bevacizumab
Docetaxel 100 mg/m^2 plus bevacizumab 15.0 mg/kgExperimentalParticipants received docetaxel 100 mg/m^2 intravenously on Day 1 of each 3 week cycle for a maximum of 27 weeks (9 cycles). In addition, participants received bevacizumab 15.0 mg/kg intravenously on Day 1 of each 3 week cycle until disease progression, unacceptable toxicity, or participant withdrawal.
Receives: Drug: Docetaxel; Drug: Bevacizumab

What is being measured

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

  1. Progression-free Survival

    Progression-free survival was evaluated using Response Evaluation Criteria In Solid Tumors (RECIST 1.0). Progression-free survival was defined as the time from randomization to the time of the first documented disease progression or death, whichever occurred first. Disease progression was defined as ≥ 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since treatment started or the unequivocal progression of existing non-target lesions, or appearance of new lesion(s).

    Measured: Baseline to the 15 Sep 2008 cut-off date (up to 2 years, 6 months)

Secondary outcomes (4)

  1. Percentage of Participants With a Complete Response or a Partial Response

    Responses were evaluated using the Response Evaluation Criteria in Solid Tumors. A complete response was defined as the disappearance of all target lesions or the disappearance of all non-target lesions and normalization of tumor marker level. A partial response was defined as at least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum longest diameter.

    Measured: Baseline to the 15 Sep 2008 cut-off date (up to 2 years, 6 months)

  2. Duration of Response

    Duration of response was defined as the time from the first documented complete response or partial response to disease progression or death. A complete response was defined as the disappearance of all target lesions or the disappearance of all non-target lesions and normalization of tumor marker level. A partial response was defined as at least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum longest diameter. Responses were evaluated using the Response Evaluation Criteria in Solid Tumors.

    Measured: Baseline to the 15 September 2008 cut-off date (up to 2 years, 6 months)

  3. Time to Treatment Failure

    Time to treatment failure was defined as time from randomization to the date of disease progression, death, or withdrawal of treatment due to an adverse event, withdrawal of informed consent, insufficient therapeutic response, refusal of treatment/failure to co-operate, or failure to return, whichever occurred first.

    Measured: Baseline to the 15 September 2008 cut-off date (up to 2 years, 6 months)

  4. Overall Survival

    Overall survival was defined as the time from randomization to death from any cause.

    Measured: Baseline to the 15 Sep 2008 cut-off date (up to 2 years, 6 months)

Timeline

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

  1. First posted6 Jun 2006 (estimated)
  2. Study startMar 2006
  3. Primary completionOct 2007
  4. Study completionOct 2013

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
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
736 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00333775
Sponsor's protocol ID
BO17708
Other IDs
2005-003862-40, 2005
Status last verified
Dec 2015
First submitted
5 Jun 2006
Last updated
27 Jan 2016

Publications

  • Wedam SB, Beaver JA, Amiri-Kordestani L, Bloomquist E, Tang S, Goldberg KB, Sridhara R, Ibrahim A, Kim G, Kluetz P, McKee A, Pazdur R. US Food and Drug Administration Pooled Analysis to Assess the Impact of Bone-Only Metastatic Breast Cancer on Clinical Trial Outcomes and Radiographic Assessments. J Clin Oncol. 2018 Apr 20;36(12):1225-1231. doi: 10.1200/JCO.2017.74.6917. Epub 2018 Mar 9.

    PubMed 29522361

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Docetaxel and Bevacizumab in people with Breast Cancer, run by Hoffmann-La Roche at 114 sites in 24 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 7 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 27 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 114 sites in Germany, United Kingdom, Canada, Italy, Australia and 19 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 27 Jan 2016). 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 (time frame: Baseline to the 15 Sep 2008 cut-off date (up to 2 years, 6 months)). 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 NCT00333775, which also lists 1 linked publication.

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 27 Jan 2016.

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