Breast NeoplasmsPhase 2NCT00386685
XRP9881 in Combination With Trastuzumab in Metastatic Breast Cancer
A Phase 2 study testing larotaxel (XRP9881) and trastuzumab in people with Breast Neoplasms, run by Sanofi at 4 sites in 4 countries.
Trial summary
The primary objective of the study is to assess the activity of XRP9881 in combination with trastuzumab. The secondary objectives are safety and pharmacokinetic interaction Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Neoplasms
- What is being tested?
- larotaxel (XRP9881) and trastuzumab
- Type of treatment
- Injection or infusion
- How many people
- 51 participants
- Where
- 4 sitesin 4 countries
- Study dates
- Jul 2006to Jan 2011
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Metastatic breast cancer (MBC)
- HER2 (Human Epidermal Growth Factor Receptor 2) positive: FISH (Fluorescent In Situ Hybridization) positive or IHC (Immunohistochemistry) 3+
- Measurable disease according to Response Evaluation Criteria In Solid Tumors (RECIST)
- Adequate organs functions
Who cannot join
- More than one previous chemotherapy regimen for metastatic disease
- Cardiac dysfunction
Trial locations and contacts
4 sites in 4 countries.
4 sites in 4 countries
About this study
Official title: Open Label, Uncontrolled Study of XRP9881 in Combination With Trastuzumab (Herceptin®) in Patients With HER2 Positive Metastatic Breast Cancer (MBC)
The primary objective of the study is to assess the activity of XRP9881 in combination with trastuzumab.
The secondary objectives are safety and pharmacokinetic interaction
- Conditions
- Breast Neoplasms
- Being tested
- larotaxel (XRP9881), trastuzumab
- Keywords
- Cancer, Breast, metastatic breast cancer
- Medical subject headings
- Breast Neoplasms, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
larotaxel (XRP9881)Drug
intravenous administration
trastuzumabDrug
intravenous administration
What is being measured
The primary outcome is the main question the study is designed to answer.
Response rate (best overall response under treatment)
Measured: study period
Secondary outcomes (1)
Incidence of grade 3-4 toxicities, pharmacokinetic interaction
Measured: study period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2006 (estimated)
- Study startJul 2006
- Primary completionOct 2008
- Study completionJan 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast NeoplasmsStudies of the same condition, open and under way.
- More trials run by SanofiThe 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
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Henri Roche, PhD, Principal investigator, Institut Claudius Regaud - Toulouse - France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00386685
- Sponsor's protocol ID
- TCD6595
- Other IDs
- XRP9881
- Status last verified
- Apr 2011
- First submitted
- 10 Oct 2006
- Last updated
- 12 Apr 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open Label, Uncontrolled Study of XRP9881 in Combination With Trastuzumab (Herceptin®) in Patients With HER2 Positive Metastatic Breast Cancer (MBC)
- ClinicalTrials.gov ID
- NCT00386685
- Acronym / sponsor ID
- TCD6595
- Conditions
- Breast Neoplasms
- Keywords
- Cancer, Breast, metastatic breast cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- Jul 2006
- Primary completion
- Oct 2008 (actual)
- Study completion
- Jan 2011 (actual)
- First posted
- 11 Oct 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.
The primary objective of the study is to assess the activity of XRP9881 in combination with trastuzumab.
The secondary objectives are safety and pharmacokinetic interaction
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- 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 (4 listed)
- Metastatic breast cancer (MBC)
- HER2 (Human Epidermal Growth Factor Receptor 2) positive: FISH (Fluorescent In Situ Hybridization) positive or IHC (Immunohistochemistry) 3+
- Measurable disease according to Response Evaluation Criteria In Solid Tumors (RECIST)
- Adequate organs functions
Key exclusion criteria (2 listed)
- More than one previous chemotherapy regimen for metastatic disease
- Cardiac dysfunction
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 |
|---|---|---|
| larotaxel (XRP9881)intravenous administration | Drug | – |
| trastuzumabintravenous administration | Drug | – |
Primary outcome
Response rate (best overall response under treatment)
Time frame: study period
1 secondary outcome
Incidence of grade 3-4 toxicities, pharmacokinetic interaction
Time frame: study period
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 12 Apr 2011.
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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.
Henri Roche, PhD principal investigator
Institut Claudius Regaud - Toulouse - France
4 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing larotaxel (XRP9881) and trastuzumab in people with Breast Neoplasms, run by Sanofi at 4 sites in 4 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 2 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 12 Apr 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Belgium, France, Sweden, Switzerland. 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?
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?
Response rate (best overall response under treatment) (time frame: study period). 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 12 Apr 2011.