Treatment of Larotaxel/Docetaxel, +/- Trastuzumab, After Anthracycline-cyclophosphamide in Breast Cancer Patients (SATIN)
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ClinicalTrials.gov Identifier: NCT00485979 |
Recruitment Status :
Completed
First Posted : June 13, 2007
Last Update Posted : June 28, 2011
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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.
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Breast Neoplasms | Drug: larotaxel (XRP9881) Drug: docetaxel Drug: trastuzumab | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 330 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
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. |
Study Start Date : | June 2007 |
Actual Primary Completion Date : | August 2010 |
Actual Study Completion Date : | August 2010 |

Arm | Intervention/treatment |
---|---|
Experimental: Arm A1
Cohort 1: Her2-ve breast cancer
|
Drug: larotaxel (XRP9881)
intravenous administration |
Active Comparator: Arm B1
Cohort 1: Her2-ve breast cancer
|
Drug: docetaxel
intravenous administration |
Experimental: Arm A2
Cohort 2: Her2+ve breast cancer
|
Drug: larotaxel (XRP9881)
intravenous administration Drug: trastuzumab intravenous administration |
Active Comparator: Arm B2
Cohort 2: Her2+ve breast cancer
|
Drug: docetaxel
intravenous administration Drug: trastuzumab intravenous administration |
- Pathological response will be assessed according to Chevallier criteria for patients who underwent surgery. [ Time Frame: treatment period ]
- 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 ]

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Ages Eligible for Study: | 18 Years to 75 Years (Adult, Older Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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)
Exclusion Criteria:
- 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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00485979
Belgium | |
Sanofi-Aventis Administrative Office | |
Diegem, Belgium | |
Brazil | |
Sanofi-Aventis Administrative Office | |
Sao Paulo, Brazil | |
France | |
Sanofi-Aventis Administrative Office | |
Paris, France | |
Germany | |
Sanofi-Aventis Administrative Office | |
Berlin, Germany | |
Poland | |
Sanofi-Aventis Administrative Office | |
Warszawa, Poland | |
Tunisia | |
Sanofi-Aventis Administrative Office | |
Megrine, Tunisia | |
United Kingdom | |
Sanofi-Aventis Administrative Office | |
Guildford, United Kingdom | |
Uruguay | |
Sanofi-Aventis Administrative Office | |
Montevideo, Uruguay |
Principal Investigator: | Michel Marty, MD | Centre for Therapeutic Innovations in Oncology and Haematology / Saint Louis University Hospital |
Responsible Party: | Trial Transparency Team, sanofi-aventis |
ClinicalTrials.gov Identifier: | NCT00485979 |
Other Study ID Numbers: |
EFC10073 EudraCT 2006-006473-24 |
First Posted: | June 13, 2007 Key Record Dates |
Last Update Posted: | June 28, 2011 |
Last Verified: | June 2011 |
Breast Cancer Neoadjuvant therapy |
Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases Docetaxel Trastuzumab |
Antineoplastic Agents Tubulin Modulators Antimitotic Agents Mitosis Modulators Molecular Mechanisms of Pharmacological Action Antineoplastic Agents, Immunological |