XRP9881 in Combination With Trastuzumab in Metastatic Breast Cancer

Sanofi51 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Breast Neoplasms

Interventions

larotaxel (XRP9881)DRUG

intravenous administration

trastuzumabDRUG

intravenous administration

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * 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 Exclusion Criteria: * More than one previous chemotherapy regimen for metastatic disease * Cardiac dysfunction

Locations (4)

Sanofi-Aventis Administrative Office

Diegem, Belgium

Sanofi-Aventis Administrative Office

Paris, France

Sanofi-Aventis Administrative Office

Bromma, Sweden

Sanofi-Aventis Administrative Office

Geneva, Switzerland

Outcomes

Primary Outcomes

Response rate (best overall response under treatment)

Time frame: study period

Secondary Outcomes

Incidence of grade 3-4 toxicities, pharmacokinetic interaction

Time frame: study period

Data from ClinicalTrials.gov

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