Metastatic Breast CancerPhase 1NCT00367250
Safety Study of Combined Immunotherapy With Trastuzumab and Cetuximab in Patients With Metastatic Breast Cancer
A Phase 1 study testing Cetuximab and Trastuzumab in people with Metastatic Breast Cancer, run by Medical University of Vienna at 1 site in Austria.
Trial summary
One important approach to change the natural history of advanced breast cancer is that of designing new combination chemotherapies in which the best drugs already available are used together with new anticancer agents devoid of clinical cross-resistance. 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?
- Cetuximab and Trastuzumab
- Type of treatment
- Injection or infusion
- How many people
- 32 participants
- Where
- 1 siteAustria
- Study dates
- Jul 2006to Jun 2011
- Phase
- Phase 1
- 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
- diagnosis of metastatic breast cancer
- presence of at least 1 measurable lesion according to modified RECIST criteria
- Evidence (fluorescence in situ hybridization FISH) of
- Her-2 overexpression in tumor tissue:Group A: Her-2 +++, Group B: Her-2 + or ++
- EGFR-expressing disease as assessed by immunohistochemistry
- Recovered from relevant toxicities from other treatment prior to study entry
Who cannot join
- Prior treatment with trastuzumab for metastatic breast cancer (adjuvant therapy is allowed)
- Prior treatment with cetuximab
- Concomitant cytotoxic chemotherapy
- Treatment with any investigational agent(s) within 4 weeks prior to study entry
- Known allergic/hypersensitivity reaction to any of the components of study treatments
- severe dyspnea
- Myocardial infarction within 6 months prior to study entry, uncontrolled congestive heart failure; or any current grade 3 or 4 cardio-vascular disorder despite treatment
- History of significant neurologic or psychiatric disorders
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase I Study Investigating the Combined Immunotherapy With Trastuzumab and Cetuximab in Patients With Metastatic Breast Cancer With High and Moderate HER2 Expression
One important approach to change the natural history of advanced breast cancer is that of designing new combination chemotherapies in which the best drugs already available are used together with new anticancer agents devoid of clinical cross-resistance. The possibility of exploiting the combined use of cetuximab and trastuzumab represents an option of potential great impact on the probability of response and long-term therapeutic results for patients with advanced breast cancer and HER2 overexpression.Therefore, patients with tumors that demonstrate EGFR expression and clear-cut erbB-2 overexpression (3+) or limited erbB-2 overexpression (+ or 2+) will be included in the study. Patients will be treated with trastuzumab and cetuximab to study the pharmacokinetics and potential drug/drug interaction of both antibodies as well as the safety and tolerability of this novel combination treatment.
- Conditions
- Metastatic Breast Cancer
- Being tested
- Cetuximab, Trastuzumab
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CetuximabDrug
weekly i.v.
TrastuzumabDrug
weekly i.v.
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetics and drug/drug interaction of cetuximab and
Measured: repeated PK measurements week 1-13
Secondary outcomes (2)
Safety and tolerability of the combination treatment
Measured: week 1 -13
Response
Measured: week 9 and 13
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2006 (estimated)
- Study startJul 2006
- Primary completionJun 2011 (estimated)
- Study completionJun 2011 (estimated)
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 Medical University of ViennaThe 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 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Investigators
- Christoph Zielinski, MD, Principal investigator, Dept of Internal Medicine, Medical University Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00367250
- Sponsor's protocol ID
- CETRA 01
- Status last verified
- Sep 2010
- First submitted
- 21 Aug 2006
- Last updated
- 28 Sep 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Study Investigating the Combined Immunotherapy With Trastuzumab and Cetuximab in Patients With Metastatic Breast Cancer With High and Moderate HER2 Expression
- ClinicalTrials.gov ID
- NCT00367250
- Acronym / sponsor ID
- CETRA 01
- Conditions
- Metastatic Breast Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- Jul 2006
- Primary completion
- Jun 2011 (estimated)
- Study completion
- Jun 2011 (estimated)
- First posted
- 22 Aug 2006 (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.
One important approach to change the natural history of advanced breast cancer is that of designing new combination chemotherapies in which the best drugs already available are used together with new anticancer agents devoid of clinical cross-resistance. The possibility of exploiting the combined use of cetuximab and trastuzumab represents an option of potential great impact on the probability of response and long-term therapeutic results for patients with advanced breast cancer and HER2 overexpression.Therefore, patients with tumors that demonstrate EGFR expression and clear-cut erbB-2 overexpression (3+) or limited erbB-2 overexpression (+ or 2+) will be included in the study. Patients will be treated with trastuzumab and cetuximab to study the pharmacokinetics and potential drug/drug interaction of both antibodies as well as the safety and tolerability of this novel combination treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- diagnosis of metastatic breast cancer
- presence of at least 1 measurable lesion according to modified RECIST criteria
- Evidence (fluorescence in situ hybridization FISH) of
- Her-2 overexpression in tumor tissue:Group A: Her-2 +++, Group B: Her-2 + or ++
- EGFR-expressing disease as assessed by immunohistochemistry
Key exclusion criteria (8 listed)
- Prior treatment with trastuzumab for metastatic breast cancer (adjuvant therapy is allowed)
- Prior treatment with cetuximab
- Concomitant cytotoxic chemotherapy
- Treatment with any investigational agent(s) within 4 weeks prior to study entry
- Known allergic/hypersensitivity reaction to any of the components of study treatments
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 |
|---|---|---|
| Cetuximabweekly i.v. | Drug | – |
| Trastuzumabweekly i.v. | Drug | – |
Primary outcome
Pharmacokinetics and drug/drug interaction of cetuximab and
Time frame: repeated PK measurements week 1-13
2 secondary outcomes
Safety and tolerability of the combination treatment
Time frame: week 1 -13
Response
Time frame: week 9 and 13
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2010.
- Dept of Oncology, Medical University ViennaLink provided by the sponsor.
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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.
Christoph Zielinski, MD principal investigator
Dept of Internal Medicine, Medical University Vienna
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Cetuximab and Trastuzumab in people with Metastatic Breast Cancer, run by Medical University of Vienna at 1 site in Austria.
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 6 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 28 Sep 2010. 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 Austria. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Christoph Wiltschke, Prof (+43 40400 4445, Christoph.Wiltschke@meduniwien.ac.at), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pharmacokinetics and drug/drug interaction of cetuximab and (time frame: repeated PK measurements week 1-13). 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 28 Sep 2010.