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Completed

NCT Number: NCT00485979

Treatment of Larotaxel/Docetaxel, +/- Trastuzumab, After Anthracycline-cyclophosphamide in Breast Cancer Patients

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.

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Key information

Conditions

Breast Neoplasms Breast Diseases Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year–75 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Sanofi-Aventis Administrative Office, Diegem, Belgium

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Larotaxel (XRP9881)

Drug

intravenous administration

docetaxel

Drug

intravenous administration

Trastuzumab

Drug

intravenous administration

Primary outcomes

  1. Pathological response will be assessed according to Chevallier criteria for patients who underwent surgery.

    Time frame: treatment period

Secondary outcomes

  1. 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

  2. Safety and tolerability profile

    Time frame: treatment period

Sponsors and collaborators

Lead sponsor

Sanofi

Industry

Registry information

Official study 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.

Acronym: SATIN

Important dates

Study start
2007
Primary completion
2010
Study completion
2010
First posted
Jun 13, 2007
Registry last updated
Jun 28, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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