Breast NeoplasmsPhase 2SATINNCT00485979
Treatment of Larotaxel/Docetaxel, +/- Trastuzumab, After Anthracycline-cyclophosphamide in Breast Cancer Patients
A Phase 2 study testing larotaxel (XRP9881), docetaxel and trastuzumab in people with Breast Neoplasms, run by Sanofi at 8 sites in 8 countries.
Trial summary
The primary objective of this study is to assess the pathological Complete Response (pCR) rate by treatment arm (according to Chevallier criteria). The secondary objectives are: to assess in each treatment arm the clinical Response Rate (RR), the rate of breast conservation, the Progression-Free Survival (PFS), the… Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Breast Neoplasms
- What is being tested?
- larotaxel (XRP9881), docetaxel and trastuzumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 330 participants
- Where
- 8 sitesin 8 countries
- Study dates
- Jun 2007to Aug 2010
- 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 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically proven invasive breast adenocarcinoma
- Localized breast cancer: stage II and III
- Tumors clinically palpable and ineligible for breast conservative surgery: unifocal tumor with diameter ≥ 3cm (clinical examination) or central unifocal tumor, or whose characteristics make pre-operative chemotherapy mandatory due to high risk factors (i.e. ipsilateral lymph nodes involvement, rapid growth rate)
- After 30 June 2008, known status for Her2neu by immunohistochemistry (IHC) or by fluorescent in situ hybridization (FISH)
Who cannot join
- Bilateral and inflammatory breast cancer
- Abnormal Left Ventricular Ejection Fraction
- Distant metastases or locoregional relapse
- Inadequate organ functions
- The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Trial locations and contacts
8 sites in 8 countries.
8 sites in 8 countries
About this study
Official title: A Randomized, Open-label, Multi-center Study of Larotaxel at 90mg/m2 or Docetaxel Every 3 Weeks, Alone or in Combination With Trastuzumab According to Her2neu Status, Administered After a Combination of Anthracycline and Cyclophosphamide as Pre-operative Therapy in Patients With High Risk Localized Breast Cancer.
The primary objective of this study is to assess the pathological Complete Response (pCR) rate by treatment arm (according to Chevallier criteria).
The secondary objectives are:
- to assess in each treatment arm the clinical Response Rate (RR), the rate of breast conservation, the Progression-Free Survival (PFS), the Overall Survival (OS), the safety and tolerability profile, the pathological Complete Response rate (pCR) according to NSABP and Sataloff criteria,
- to rank docetaxel and larotaxel alone in Her2 -ve patients, or combined with trastuzumab in Her2 +ve patients, according to the pCR rate.
- Conditions
- Breast Neoplasms
- Being tested
- larotaxel (XRP9881), docetaxel, trastuzumab
- Keywords
- Breast Cancer, Neoadjuvant therapy
- Medical subject headings
- Breast 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
docetaxelDrug
intravenous administration
trastuzumabDrug
intravenous administration
| Study group | Role | What they receive |
|---|---|---|
| Arm A1 | Experimental | Cohort 1: Her2-ve breast cancer Receives: Drug: larotaxel (XRP9881) |
| Arm B1 | Active comparator | Cohort 1: Her2-ve breast cancer Receives: Drug: docetaxel |
| Arm A2 | Experimental | Cohort 2: Her2+ve breast cancer Receives: Drug: larotaxel (XRP9881); Drug: trastuzumab |
| Arm B2 | Active comparator | Cohort 2: Her2+ve breast cancer Receives: Drug: docetaxel; Drug: trastuzumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pathological response will be assessed according to Chevallier criteria for patients who underwent surgery.
Measured: treatment period
Secondary outcomes (2)
Clinical Response Rate, Rate of breast conservation, Progression-Free Survival, Overall Survival, pathological response according to NSABP and Sataloff criteria for patients who underwent surgery
Measured: treatment period
Safety and tolerability profile
Measured: treatment period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2007 (estimated)
- Study startJun 2007
- Primary completionAug 2010
- Study completionAug 2010
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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 330 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Michel Marty, MD, Principal investigator, Centre for Therapeutic Innovations in Oncology and Haematology / Saint Louis University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00485979
- Sponsor's protocol ID
- EFC10073
- Other IDs
- EudraCT 2006-006473-24
- Acronym
- SATIN
- Status last verified
- Jun 2011
- First submitted
- 12 Jun 2007
- Last updated
- 28 Jun 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-label, Multi-center Study of Larotaxel at 90mg/m2 or Docetaxel Every 3 Weeks, Alone or in Combination With Trastuzumab According to Her2neu Status, Administered After a Combination of Anthracycline and Cyclophosphamide as Pre-operative Therapy in Patients With High Risk Localized Breast Cancer.
- ClinicalTrials.gov ID
- NCT00485979
- Acronym / sponsor ID
- SATIN / EFC10073
- Conditions
- Breast Neoplasms
- Keywords
- Breast Cancer, Neoadjuvant therapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 330 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- Jun 2007
- Primary completion
- Aug 2010 (actual)
- Study completion
- Aug 2010 (actual)
- First posted
- 13 Jun 2007 (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 this study is to assess the pathological Complete Response (pCR) rate by treatment arm (according to Chevallier criteria).
The secondary objectives are:
- to assess in each treatment arm the clinical Response Rate (RR), the rate of breast conservation, the Progression-Free Survival (PFS), the Overall Survival (OS), the safety and tolerability profile, the pathological Complete Response rate (pCR) according to NSABP and Sataloff criteria,
- to rank docetaxel and larotaxel alone in Her2 -ve patients, or combined with trastuzumab in Her2 +ve patients, according to the pCR rate.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Arm A1 | Experimental | Drug: larotaxel (XRP9881)Cohort 1: Her2-ve breast cancer |
| Arm B1 | Active comparator | Drug: docetaxelCohort 1: Her2-ve breast cancer |
| Arm A2 | Experimental | Drug: larotaxel (XRP9881), Drug: trastuzumabCohort 2: Her2+ve breast cancer |
| Arm B2 | Active comparator | Drug: docetaxel, Drug: trastuzumabCohort 2: Her2+ve breast cancer |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Histologically proven invasive breast adenocarcinoma
- Localized breast cancer: stage II and III
- Tumors clinically palpable and ineligible for breast conservative surgery: unifocal tumor with diameter ≥ 3cm (clinical examination) or central unifocal tumor, or whose characteristics make pre-operative chemotherapy mandatory due to high risk factors (i.e. ipsilateral lymph nodes involvement, rapid growth rate)
- After 30 June 2008, known status for Her2neu by immunohistochemistry (IHC) or by fluorescent in situ hybridization (FISH)
Key exclusion criteria (5 listed)
- Bilateral and inflammatory breast cancer
- Abnormal Left Ventricular Ejection Fraction
- Distant metastases or locoregional relapse
- Inadequate organ functions
- The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
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 | Arm A1, Arm A2 |
| docetaxelintravenous administration | Drug | Arm B1, Arm B2 |
| trastuzumabintravenous administration | Drug | Arm A2, Arm B2 |
Primary outcome
Pathological response will be assessed according to Chevallier criteria for patients who underwent surgery.
Time frame: treatment period
2 secondary outcomes
Clinical Response Rate, Rate of breast conservation, Progression-Free Survival, Overall Survival, pathological response according to NSABP and Sataloff criteria for patients who underwent surgery
Time frame: treatment period
Safety and tolerability profile
Time frame: treatment 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 28 Jun 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.
Michel Marty, MD principal investigator
Centre for Therapeutic Innovations in Oncology and Haematology / Saint Louis University Hospital
8 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing larotaxel (XRP9881), docetaxel and trastuzumab in people with Breast Neoplasms, run by Sanofi at 8 sites in 8 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 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 28 Jun 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Belgium, Brazil, France, Germany, Poland and 3 more countries. 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?
Pathological response will be assessed according to Chevallier criteria for patients who underwent surgery. (time frame: treatment 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 28 Jun 2011.