Breast CancerPhase 2NCT00964704
A Study of Herceptin (Trastuzumab) in Combination With Avastin (Bevacizumab) and Sequential Xeloda (Capecitabine) or Docetaxel in Patients With HER2-Positive Locally Recurrent or Metastatic Breast Cancer
A Phase 2 study testing bevacizumab [Avastin], capecitabine [Xeloda] and docetaxel in people with Breast Cancer, run by Hoffmann-La Roche.
Trial summary
This single arm, open-label study will evaluate the safety and efficacy of Herceptin in combination with Avastin and sequential Xeloda in patients with locally recurrent or metastatic HER2-positive breast cancer after early relapse on adjuvant Herceptin therapy. 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 docetaxel
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Mar 2011to Aug 2013
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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
- male or female patients, age >/=18 years
- locally recurrent or metastatic HER2-positive breast cancer
- disease progression during or up to 12 months after prior adjuvant therapy with trastuzumab
- LVEF >/=55% at baseline
Who cannot join
- prior treatment with bevacizumab or capecitabine
- anthracyclines in prior adjuvant or neoadjuvant treatment exceeding cumulative dose of 360mg/m2 for doxorubicin and 720mg/kg for epirubicin
- chronic daily treatment with corticosteroids (>10mg/day methylprednisolone equivalent; excluding inhaled corticosteroids), or aspirin (>325mg/day), or clopidogrel (>75mg/day)
- clinically significant cardiac disease, or cardiac toxicity during previous trastuzumab therapy
- evidence of spinal cord compression or CNS metastasis
- history of other malignancy, unless disease-free for >/=5 years or treated curatively for carcinoma in situ of the cervix or non-melanomatous skin cancer
About this study
Official title: A Single Arm, Open-label Study to Evaluate the Efficacy on Tumor Response and the Safety of Bevacizumab and Trastuzumab Combination and Sequential Capecitabine in Patients With HER2 +Ive Locally Recurrent or Metastatic Breast Cancer After Early Relapse to Adjuvant Trastuzumab-containing Therapy
This single arm, open-label study will evaluate the safety and efficacy of Herceptin in combination with Avastin and sequential Xeloda in patients with locally recurrent or metastatic HER2-positive breast cancer after early relapse on adjuvant Herceptin therapy. Patients will receive Herceptin at a loading dose of 8mg/kg iv followed by 6mg/kg iv every three weeks, and Avastin 15mg/kg every 3 weeks. At first sign of disease progression Xeloda 1000mg/m2 bid po will be added on days 1-14 of each cycle, or docetaxel (100mg/m2 iv every 3 weeks) if Xeloda is not indicated for a patient. Anticipated time on study treatment is until disease-progression on second line treatment and target sample size is <100.
- Conditions
- Breast Cancer
- Being tested
- bevacizumab [Avastin], capecitabine [Xeloda], docetaxel, 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 every 3 weeks
capecitabine [Xeloda]Drug
added at time of disease-progression, 1000mg/m2 bid po days 1-14 of every 3-week cycle
docetaxelDrug
background therapy at time of disease progression, 100mg/m2 iv every 3 weeks
trastuzumab [Herceptin]Drug
8mg/kg iv on day 1 of the first 3-week cycle, followed by 6mg/kg every 3 weeks
| Study group | Role | What they receive |
|---|---|---|
| Single Arm | Experimental | Not described Receives: Drug: bevacizumab [Avastin]; Drug: capecitabine [Xeloda]; Drug: docetaxel; Drug: trastuzumab [Herceptin] |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-Free Survival on second-line treatment
Measured: event-driven, tumour assessments every 6 weeks for 24 weeks, every 12 weeks thereafter
Secondary outcomes (2)
Safety and tolerability: AEs, laboratory parameters, LVEF
Measured: throughout study, laboratory parameters every 3 weeks, LVEF every 12 weeks
Overall Response Rate, Best Overall Response, Duration of Response, Progression-free Survival (first-line), Overall Survival
Measured: event-driven, tumour assessment every 6 weeks for 24 weeks, every 12 weeks thereafter
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2009 (estimated)
- Study startMar 2011
- Primary completionAug 2013 (estimated)
- Study completionAug 2013 (estimated)
Why it stopped: No patients have been recruited therefore study has been cancelled
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Hoffmann-La RocheThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hoffmann-La Roche
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study director, Hoffmann-La Roche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00964704
- Sponsor's protocol ID
- ML22056
- Other IDs
- 2008-007495-20, 2008
- Status last verified
- Nov 2016
- First submitted
- 21 Aug 2009
- Last updated
- 2 Nov 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Arm, Open-label Study to Evaluate the Efficacy on Tumor Response and the Safety of Bevacizumab and Trastuzumab Combination and Sequential Capecitabine in Patients With HER2 +Ive Locally Recurrent or Metastatic Breast Cancer After Early Relapse to Adjuvant Trastuzumab-containing Therapy
- ClinicalTrials.gov ID
- NCT00964704
- Acronym / sponsor ID
- ML22056
- Conditions
- Breast Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No patients have been recruited therefore study has been cancelled
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- Mar 2011
- Primary completion
- Aug 2013 (estimated)
- Study completion
- Aug 2013 (estimated)
- First posted
- 25 Aug 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This single arm, open-label study will evaluate the safety and efficacy of Herceptin in combination with Avastin and sequential Xeloda in patients with locally recurrent or metastatic HER2-positive breast cancer after early relapse on adjuvant Herceptin therapy. Patients will receive Herceptin at a loading dose of 8mg/kg iv followed by 6mg/kg iv every three weeks, and Avastin 15mg/kg every 3 weeks. At first sign of disease progression Xeloda 1000mg/m2 bid po will be added on days 1-14 of each cycle, or docetaxel (100mg/m2 iv every 3 weeks) if Xeloda is not indicated for a patient. Anticipated time on study treatment is until disease-progression on second line treatment and target sample size is <100.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single Arm | Experimental | Drug: bevacizumab [Avastin], Drug: capecitabine [Xeloda], Drug: docetaxel, Drug: trastuzumab [Herceptin] |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- male or female patients, age >/=18 years
- locally recurrent or metastatic HER2-positive breast cancer
- disease progression during or up to 12 months after prior adjuvant therapy with trastuzumab
- LVEF >/=55% at baseline
Key exclusion criteria (6 listed)
- prior treatment with bevacizumab or capecitabine
- anthracyclines in prior adjuvant or neoadjuvant treatment exceeding cumulative dose of 360mg/m2 for doxorubicin and 720mg/kg for epirubicin
- chronic daily treatment with corticosteroids (>10mg/day methylprednisolone equivalent; excluding inhaled corticosteroids), or aspirin (>325mg/day), or clopidogrel (>75mg/day)
- clinically significant cardiac disease, or cardiac toxicity during previous trastuzumab therapy
- evidence of spinal cord compression or CNS metastasis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| bevacizumab [Avastin]15mg/kg iv every 3 weeks | Drug | Single Arm |
| capecitabine [Xeloda]added at time of disease-progression, 1000mg/m2 bid po days 1-14 of every 3-week cycle | Drug | Single Arm |
| docetaxelbackground therapy at time of disease progression, 100mg/m2 iv every 3 weeks | Drug | Single Arm |
| trastuzumab [Herceptin]8mg/kg iv on day 1 of the first 3-week cycle, followed by 6mg/kg every 3 weeks | Drug | Single Arm |
Primary outcome
Progression-Free Survival on second-line treatment
Time frame: event-driven, tumour assessments every 6 weeks for 24 weeks, every 12 weeks thereafter
2 secondary outcomes
Safety and tolerability: AEs, laboratory parameters, LVEF
Time frame: throughout study, laboratory parameters every 3 weeks, LVEF every 12 weeks
Overall Response Rate, Best Overall Response, Duration of Response, Progression-free Survival (first-line), Overall Survival
Time frame: event-driven, tumour assessment every 6 weeks for 24 weeks, every 12 weeks thereafter
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Trials study director
Hoffmann-La Roche
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing bevacizumab [Avastin], capecitabine [Xeloda] and docetaxel in people with Breast Cancer, run by Hoffmann-La Roche.
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 6 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: withdrawn, as of the sponsor's last update on 2 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
The study was withdrawn before enrolling participants, so there are no results.
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 on second-line treatment (time frame: event-driven, tumour assessments every 6 weeks for 24 weeks, every 12 weeks thereafter). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Nov 2016.