AzTrials
AzTrials

Breast CancerPhase 2NCT00811135

A Study of Avastin (Bevacizumab) in Combination With Herceptin (Trastuzumab) and Xeloda (Capecitabine) in Patients With HER2-Positive Breast Cancer

A Phase 2 study testing bevacizumab [Avastin], capecitabine [Xeloda] and trastuzumab [Herceptin] in people with Breast Cancer, run by Hoffmann-La Roche at 35 sites in 6 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 single arm study will assess the efficacy and safety of Avastin in combination with Herceptin and Xeloda as first-line treatment of patients with HER2-positive locally recurrent or metastatic breast cancer. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Breast Cancer
What is being tested?
bevacizumab [Avastin], capecitabine [Xeloda] and trastuzumab [Herceptin]
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
88 participants
Where
35 sitesin 6 countries
Study dates
Dec 2008to Dec 2015
Phase
Phase 2
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
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • adult patients, >=18 years of age;
  • breast cancer with measurable locally recurrent or metastatic lesions;
  • candidate for chemotherapy;
  • HER2-positive disease;
  • ECOG PS of <=2.

Who cannot join

  • previous anticancer therapy for metastatic breast cancer;
  • previous radiotherapy for metastatic breast cancer (except for adjuvant radiotherapy >=6 months before enrollment);
  • chronic daily treatment with corticosteroids (>=10mg/day), aspirin (>325 mg/day) or clopidogrel (>75mg/day);
  • other primary tumor within last 5 years, except for adequately treated cervical cancer in situ, squamous or basal cell skin cancer;
  • uncontrolled hypertension or significant cardiovascular disease.

Trial locations and contacts

35 sites in 6 countries.

35 sites in 6 countries

France15 sites

  • Study site

    Aix-en-Provence, 13616

  • Study site

    Béziers, 34500

  • Study site

    Créteil, 94010

  • Study site

    Dechy, 59187

  • Study site

    Lormont, 33310

  • Study site

    Marseille, 13285

  • Study site

    Narbonne, 11780

  • Study site

    Paris, 75475

  • Study site

    Paris, 75571

  • Study site

    Paris, 75651

  • Study site

    Paris, 75970

  • Study site

    Rodez, 12027

  • Study site

    Saint-Jean, 31240

  • Study site

    Saint-Quentin, 02321

  • Study site

    Toulouse, 31076

Other trials in France

Spain10 sites

  • Study site

    Barakaldo, Vizcaya, 48903

  • Study site

    Barcelona, Barcelona, 08036

  • Study site

    Madrid, Madrid, 28007

  • Study site

    Madrid, Madrid, 28040

  • Study site

    Málaga, Malaga, 29010

  • Study site

    Pontevedra, Pontevedra, 36002

  • Study site

    Salamanca, Salamanca, 37007

  • Study site

    Seville, Sevilla, 41013

  • Study site

    Valencia, Valencia, 46010

  • Study site

    Valencia, Valencia, 46026

Other trials in Spain

Sweden4 sites

  • Study site

    Eskilstuna, 63188

  • Study site

    Sundsvall, 85186

  • Study site

    Uppsala, 75185

  • Study site

    Vaxjo, 35185

Other trials in Sweden

Russia3 sites

  • Study site

    Moscow, 115478

  • Study site

    Moscow, 143423

  • Study site

    Saint Petersburg, 197758

Other trials in Russia

Denmark2 sites

  • Study site

    Herlev, 2730

  • Study site

    Vejle, 7100

Other trials in Denmark

Slovakia1 site

  • Study site

    Bratislava, 833 10

Other trials in Slovakia

About this study

Official title: A Single Arm Open-label, Phase II Study of Bevacizumab in Combination With Trastuzumab and Capecitabine as First-line Treatment of Patients With HER2-positive Locally Recurrent or Metastatic Breast Cancer

This single arm study will assess the efficacy and safety of Avastin in combination with Herceptin and Xeloda as first-line treatment of patients with HER2-positive locally recurrent or metastatic breast cancer. Patients will receive 3-weekly treatment cycles of Herceptin (8mg/kg iv on day 1 of first cycle, followed by 6mg/kg iv maintenance dose on day 1 of subsequent cycles), Xeloda (1000mg/m2 bid po on days 1-14 of each treatment cycle) and Avastin (15mg/kg on day 2 of first treatment cycle,and on day 1 of each subsequent cycle).The anticipated time on study treatment is until disease progression, and the target sample size is <100 individuals.

Conditions
Breast Cancer
Being tested
bevacizumab [Avastin], capecitabine [Xeloda], trastuzumab [Herceptin]
Medical subject headings
Breast Neoplasms

What participants receive

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

  • bevacizumab [Avastin]Drug

    15mg/kg iv on day 2 of first 3-week cycle,and on day 1 of subsequent cycles

  • capecitabine [Xeloda]Drug

    1000mg/m2 bid po on days 1-14 of each 3-week cycle

  • trastuzumab [Herceptin]Drug

    8mg/kg iv loading dose on day 1 of first 3-week cycle, followed by 6mg/kg iv maintenance dose on day 1 of subsequent cycles

Study groups in NCT00811135
Study groupRoleWhat they receive
1ExperimentalNot described
Receives: Drug: bevacizumab [Avastin]; Drug: capecitabine [Xeloda]; Drug: trastuzumab [Herceptin]

What is being measured

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

  1. Percentage of Participants With a Best Overall Response (BOR) of Confirmed Complete Response (CR) or Partial Response (PR)

    Tumor response was assessed using the Response Evaluation Criteria in Solid Tumors (RECIST), Version 1.0. BOR was defined as the best response recorded for a participant from the start of treatment until disease progression/recurrence. Percentage of participants with a BOR of confirmed CR or PR (responders) was reported. CR: disappearance of all target and non-target lesions and normalization of tumor marker level; PR: at least a 30 percent (%) decrease in the sum of the longest diameter (LD) of target lesions taking as reference the baseline sum LD. Confirmed responses were those which were confirmed by a repeat assessment, performed 4 weeks after the criteria for response first met.

    Measured: Screening until disease progression (assessed at screening, every 6 weeks up to Week 36, thereafter every 9 weeks during treatment period, and then every 3 months during follow-up, up to approximately 4 years)

Secondary outcomes (8)

  1. Number of Participants With Disease Progression or Death

    Disease progression was defined as at least a 20% increase in the sum of LD of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions.

    Measured: Screening until disease progression (assessed at screening, every 6 weeks up to Week 36, thereafter every 9 weeks during treatment period, and then every 3 months during follow-up, up to approximately 4 years)

  2. Progression Free Survival (PFS)

    PFS was defined as the time from enrollment to time of first documented disease progression or death due to any cause, whichever occurred first. Progression: at least a 20% increase in the sum of LD of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions. PFS was estimated using Kaplan-Meier methods.

    Measured: Screening until disease progression (assessed at screening, every 6 weeks up to Week 36, thereafter every 9 weeks during treatment period, and then every 3 months during follow-up, up to approximately 4 years)

  3. Number of Participants With Overall Survival (OS)

    OS was defined as the time from enrollment to death from any cause where enrollment was defined as successfully passed screening visit, enrolled in the study and received first dose of study treatment.

    Measured: Screening until death (assessed at screening, every 6 weeks up to Week 36, thereafter every 9 weeks during treatment period, and then every 3 months during follow-up, up to approximately 4 years)

  4. Overall Survival (OS)

    OS was defined as the time from enrollment to death from any cause where enrollment was defined as successfully passed screening visit, enrolled in the study and received first dose of study treatment. OS was estimated using Kaplan-Meier methods.

    Measured: Screening until death (assessed at screening, every 6 weeks up to Week 36, thereafter every 9 weeks during treatment period, and then every 3 months during follow-up, up to approximately 4 years)

  5. Number of Participants With Time to Progression (TTP)

    TTP was defined as the time from enrollment to first documented disease progression (at least a 20% increase in the sum of LD of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions). TTP was estimated using Kaplan-Meier methods.

    Measured: Screening until disease progression (assessed at screening, every 6 weeks up to Week 36, thereafter every 9 weeks during treatment period, and then every 3 months during follow-up, up to approximately 4 years)

  6. Time to Progression (TTP)

    TTP was defined as the time from enrollment to first documented disease progression (at least a 20% increase in the sum of LD of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions).

    Measured: Screening until disease progression (assessed at screening, every 6 weeks up to Week 36, thereafter every 9 weeks during treatment period, and then every 3 months during follow-up, up to approximately 4 years)

  7. Number of Participants With Response

    Participants who had CR or PR were considered as responders. CR: disappearance of all target and non-target lesions and normalization of tumor marker level; PR: at least a 30% decrease in the sum of the LD of target lesions taking as reference the baseline sum LD.

    Measured: Screening until disease progression (assessed at screening, every 6 weeks up to Week 36, thereafter every 9 weeks during treatment period, and then every 3 months during follow-up, up to approximately 4 years)

  8. Duration of Response (DR)

    DR was defined as the time from the first recorded response (CR/PR) to the date of first documented progression or death. CR: disappearance of all target lesions and non-target lesions and normalization of tumor marker level. PR: at least a 30% decrease in the sum of the LD of target lesions taking as reference the baseline sum LD. Progression: at least a 20% increase in the sum of LD of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions. DR was estimated using Kaplan-Meier methods.

    Measured: Screening until disease progression (assessed at screening, every 6 weeks up to Week 36, thereafter every 9 weeks during treatment period, and then every 3 months during follow-up, up to approximately 4 years)

Timeline

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

  1. First posted18 Dec 2008 (estimated)
  2. Study startDec 2008
  3. Primary completionDec 2015
  4. Study completionDec 2015

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 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
88 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00811135
Sponsor's protocol ID
MO21926
Other IDs
2008-003283-20, 2008
Status last verified
Aug 2016
First submitted
16 Dec 2008
Last updated
29 Sep 2016

Publications

  • Martin M, Makhson A, Gligorov J, Lichinitser M, Lluch A, Semiglazov V, Scotto N, Mitchell L, Tjulandin S. Phase II study of bevacizumab in combination with trastuzumab and capecitabine as first-line treatment for HER-2-positive locally recurrent or metastatic breast cancer. Oncologist. 2012;17(4):469-75. doi: 10.1634/theoncologist.2011-0344. Epub 2012 Mar 30.

    PubMed 22467666

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing bevacizumab [Avastin], capecitabine [Xeloda] and trastuzumab [Herceptin] in people with Breast Cancer, run by Hoffmann-La Roche at 35 sites in 6 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 5 inclusion and 5 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 29 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 35 sites in France, Spain, Sweden, Russia, Denmark and 1 more country. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 8 Dec 2015). 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?

Percentage of Participants With a Best Overall Response (BOR) of Confirmed Complete Response (CR) or Partial Response (PR) (time frame: Screening until disease progression (assessed at screening, every 6 weeks up to Week 36, thereafter every 9 weeks during treatment period, and then every 3 months during follow-up, up to approximately 4 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 NCT00811135, 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 29 Sep 2016.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in