Metastatic Breast CancerPhase 3CARINNCT00868634
Capecitabine and Bevacizumab ± Vinorelbine in Metastatic Breast Cancer
A Phase 3 study testing capecitabine, bevacizumab and vinorelbine in people with Metastatic Breast Cancer, run by iOMEDICO AG at 1 site in Germany.
Trial summary
The aim of the trial is to detect the superiority of the triple combination of capecitabine, bevacizumab and vinorelbine versus the combination of capecitabine and bevacizumab in patients with metastatic breast cancer. 600 patients, 300 in each treatment group, are treated until progression of disease to determine PFS. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Metastatic Breast Cancer
- What is being tested?
- capecitabine, bevacizumab and vinorelbine
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- 1 siteGermany
- Study dates
- Feb 2009to Oct 2015
- Phase
- Phase 3
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Written informed consent.
- Able to comply with the protocol.
- ECOG Performance status 0 - 2.
- Life expectancy more than 12 weeks.
- Known ER / PR status.
- Confirmed HER2/neu-negative, adenocarcinoma of the breast with measurable or non-measurable locally recurrent or metastatic disease, who are candidates for chemotherapy.
Show all 11Show fewer
- Previous (neo)adjuvant chemotherapy is allowed provided that the last dose of chemotherapy was applied more than 6 months prior to randomization.
- Previous adjuvant radiotherapy is allowed as part of the treatment of early breast cancer provided that no more than 30% of marrow-bearing bone was irradiated.
- No signs and symptoms of CHF.
- Adequate hepatic and renal function values.
- Adequate hematologic function values.
Who cannot join
- Pregnant or lactating females.
- Previous chemotherapy for metastatic or locally recurrent breast cancer.
- Previous radiotherapy for the treatment of metastatic disease (unless given for the relief of metastatic bone pain)
- Evidence of spinal cord compression or current evidence of central nervous system (CNS) metastases.
- Major surgical procedure, open biopsy or significant traumatic in-jury within 28 days prior to randomization, or anticipation of the need for major surgery during the course of the study treatment.
- History or evidence of inherited bleeding diathesis or coagulopathy with the risk of bleeding.
Show all 13Show fewer
- Uncontrolled hypertension (systolic > 150 mmHg and/or diastolic > 100 mmHg). Clinically significant (i.e. active) cardiovascular disease, requiring medication during the study and might interfere with regularity of the study treatment, or not controlled by medication.
- Non-healing wound, active peptic ulcer or bone fracture.
- History of abdominal fistula, or any grade 4 nongastrointestinal fistula, gastrointestinal perforation or intrabdominal abscess within 6 months of randomization.
- Active infection requiring i.v. antibiotics at randomization.
- Clinically significant malabsorption syndrome or inability to take oral medication.
- Known hypersensitivity to any of the study drugs or excipients.
- Concurrent treatment with any drug interfering with study medication. Concurrent participation in another clinical trial. Prior participation is allowed when the last study medication was applied more than 4 weeks prior to randomization.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Capecitabine and Bevacizumab ± Vinorelbine as 1st Line Treatment in HER-2 Negative Metastatic or Locally Advanced Inoperable Breast Cancer Patients
The aim of the trial is to detect the superiority of the triple combination of capecitabine, bevacizumab and vinorelbine versus the combination of capecitabine and bevacizumab in patients with metastatic breast cancer. 600 patients, 300 in each treatment group, are treated until progression of disease to determine PFS.
- Conditions
- Metastatic Breast Cancer
- Being tested
- capecitabine, bevacizumab, vinorelbine
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
capecitabineDrug
Also called Xeloda®
1000 mg/m2 twice daily, oral, days 1-14. Cycles are repeated every three weeks.
bevacizumabDrug
Also called Avastin®
15 mg/kg i.v., day 1 Cycles are repeated every three weeks.
capecitabineDrug
Also called Xeloda®
1000 mg/m2 twice daily, oral, days 1-14. Cycles are repeated every three weeks.
bevacizumabDrug
Also called Avastin®
15 mg/kg i.v., day 1. Cycles are repeated every three weeks.
vinorelbineDrug
Also called Navirel®
25 mg/m2 i.v., days 1+8. Cycles are repeated every three weeks.
| Study group | Role | What they receive |
|---|---|---|
| A | Active comparator | Capecitabine / Bevacizumab Receives: Drug: capecitabine; Drug: bevacizumab |
| B | Experimental | Capecitabine / Bevacizumab / Vinorelbine Receives: Drug: capecitabine; Drug: bevacizumab; Drug: vinorelbine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression free survival (PFS)
Measured: end of trial
Secondary outcomes (3)
adverse events and serious adverse events
Measured: during the whole time of treatment
Overall Response Rate (ORR = CR +PR)
Measured: end of trial
Overall Survival (OS)
Measured: end of trial
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2009 (estimated)
- Study startFeb 2009
- Primary completionMar 2014
- Study completionOct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Breast CancerStudies of the same condition, open and under way.
- More trials run by iOMEDICO AGThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 600 participants (actual)
Sponsor and investigators
- Lead sponsor
- iOMEDICO AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Arbeitsgemeinschaft fur Internistische Onkologie, Arbeitskreis Klinische Studien, Roche Pharma AG
- Responsible party
- Sponsor
- Investigators
- Susanna Hegewisch-Becker, MD, Principal investigator, Onkologische Schwerpunktpraxis Eppendorf
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00868634
- Sponsor's protocol ID
- IOM-080-2
- Other IDs
- 2008-003779-37, 2008
- Acronym
- CARIN
- Status last verified
- Aug 2016
- First submitted
- 23 Mar 2009
- Last updated
- 31 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Capecitabine and Bevacizumab ± Vinorelbine as 1st Line Treatment in HER-2 Negative Metastatic or Locally Advanced Inoperable Breast Cancer Patients
- ClinicalTrials.gov ID
- NCT00868634
- Acronym / sponsor ID
- CARIN / IOM-080-2
- Conditions
- Metastatic Breast Cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 600 participants (actual)
- Lead sponsor
- iOMEDICO AGIndustry (pharma, biotech, devices)
- Collaborators
- Arbeitsgemeinschaft fur Internistische Onkologie, Arbeitskreis Klinische Studien, Roche Pharma AG
- Study start
- Feb 2009
- Primary completion
- Mar 2014 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 25 Mar 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.
The aim of the trial is to detect the superiority of the triple combination of capecitabine, bevacizumab and vinorelbine versus the combination of capecitabine and bevacizumab in patients with metastatic breast cancer. 600 patients, 300 in each treatment group, are treated until progression of disease to determine PFS.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Active comparator | Drug: capecitabine, Drug: bevacizumabCapecitabine / Bevacizumab |
| B | Experimental | Drug: capecitabine, Drug: bevacizumab, Drug: vinorelbineCapecitabine / Bevacizumab / Vinorelbine |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Written informed consent.
- Able to comply with the protocol.
- ECOG Performance status 0 - 2.
- Life expectancy more than 12 weeks.
- Known ER / PR status.
Key exclusion criteria (13 listed)
- Pregnant or lactating females.
- Previous chemotherapy for metastatic or locally recurrent breast cancer.
- Previous radiotherapy for the treatment of metastatic disease (unless given for the relief of metastatic bone pain)
- Evidence of spinal cord compression or current evidence of central nervous system (CNS) metastases.
- Major surgical procedure, open biopsy or significant traumatic in-jury within 28 days prior to randomization, or anticipation of the need for major surgery during the course of the study treatment.
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 |
|---|---|---|
| capecitabineAlso: Xeloda®1000 mg/m2 twice daily, oral, days 1-14. Cycles are repeated every three weeks. | Drug | A |
| bevacizumabAlso: Avastin®15 mg/kg i.v., day 1 Cycles are repeated every three weeks. | Drug | A |
| capecitabineAlso: Xeloda®1000 mg/m2 twice daily, oral, days 1-14. Cycles are repeated every three weeks. | Drug | B |
| bevacizumabAlso: Avastin®15 mg/kg i.v., day 1. Cycles are repeated every three weeks. | Drug | B |
| vinorelbineAlso: Navirel®25 mg/m2 i.v., days 1+8. Cycles are repeated every three weeks. | Drug | B |
Primary outcome
Progression free survival (PFS)
Time frame: end of trial
3 secondary outcomes
adverse events and serious adverse events
Time frame: during the whole time of treatment
Overall Response Rate (ORR = CR +PR)
Time frame: end of trial
Overall Survival (OS)
Time frame: end of trial
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2016.
- Individual participant dataSharing planned: No
Related trials for Metastatic Breast Cancer
RecruitingPhase 2
Gene Signatures to Guide HR+MBC Therapy in a Diverse Cohort
Invasive Mammary Carcinoma, Metastatic Breast Cancer
Not yet recruiting
Augmented-Reality ICG Fluorescence Second-Look for Residual Nodal Disease After Axillary Dissection in Breast Cancer
Breast Cancer, Breast Neoplasms
RecruitingPhase 2
BrAin Metastasis in tripLe Negateive Breast Cancer: IvoneScimab and Trop2 ADC
Triple-Negative Breast Cancer (TNBC), Brain Metastases
RecruitingPhase 1/2
A Study Evaluating the Efficacy and Safety of Multiple Treatment Combinations in Patients With Metastatic or Locally Advanced Breast Cancer
Metastatic Breast Cancer
RecruitingObservational study
Collection of CSF Samples From Participants With Metastatic Triple Negative Breast Cancer (TNBC) and HER2+ Breast Cancer With no Prior History Nor Active Radiographically Detectable Brain Metastases
Breast Cancer, Breast Carcinoma
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.
Susanna Hegewisch-Becker, MD principal investigator
Onkologische Schwerpunktpraxis Eppendorf
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing capecitabine, bevacizumab and vinorelbine in people with Metastatic Breast Cancer, run by iOMEDICO AG at 1 site in Germany.
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 11 inclusion and 13 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 31 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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: end of trial). 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 31 Aug 2016.