HER2 positive Metastatic Breast Cancer patients MedDRA version: 8.1 Level: LLT Classification code 10055113 Term: Breast cancer metastatic
Conditions
Interventions
Product Name: XRP9881
Product Code: XRP9881 (RPR109881)
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: larotaxel
CAS Number: 192573-38-9
Current Sponsor code: RPR10988
Sponsors
sanofi-aventis recherche & développement
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Histologically or cytologically proven diagnosis of breast adenocarcinoma that is now metastatic or locally recurrent and inoperable for curative intent. - Tumor (primary or metastatic) must show the presence of the HER2 gene amplification by fluorescence in situ hybridation (FISH analysis) or 3+ on the immunohistochemistry assay (IHC). - Prior treatment with trastuzumab, in neo-adjuvant , adjuvant or metastatic setting is allowed provided that no more than one progression under trastuzumab based regimen has been reported. - Patients may have received an anthracycline and/or a taxane (paclitaxel or docetaxel) prior to entry in the protocol provided the dose of anthracycline doesn’t exceed the total cumulative dose of 360 mg/m² of doxorubicin or 750 mg/m² of epirubicin, due to potential increased risk of cardiotoxicity with trastuzumab. - Evidence of measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST). - Asymptomatic brain metastases are allowed (systematic brain CT-scan is mandatory at baseline), provided they were not pre-irradiated. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - History of hypersensitivity grade =3 to taxanes, Polysorbate-80, or to compounds with similar chemical structures. - Cardiac dysfunction with LVEF (echocardiography or MUGA scan) < 50% (due to an increased risk of cardiac toxicity with trastuzumab). The LVEF evaluation should have been performed within one month prior registration. - History of hypersensitivity grade = 3 to trastuzumab. - More than one previous chemotherapy regimen for metastatic disease. - The following breast cancer treatments are not allowed : XRP9881 or any taxane-analogs except for paclitaxel or docetaxel (e.g., epothilones , Abraxane® or experimental preparations of paclitaxel), Anti-oestrogen therapy, Prior treatment with other HER2 antagonist. - Concurrent treatment with strong inhibitors of cytochrome P450 3A4 or patients planning to receive these treatments. For patients who were receiving treatment with such agents, a one-week washout period is required prior to registration. - Any of the following within the 6 months prior to registration: myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft surgery, clinically symptomatic and uncontrolled cardiovascular disease, or clinically significant cardiac arrhythmias (grade 3-4). - History of inflammatory bowel disease or chronic diarrhea.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the antitumor activity of XRP9881 in combination with trastuzumab as assessed by objective response rate (RR) observed during the study period (lasting up to 6 months after the last patient is enrolled);Secondary Objective: - To assess the safety and tolerability of XRP9881 in combination with trastuzumab - To assess any pharmacokinetic interaction of XRP9881 and trastuzumab when given in combination - To evaluate the progression-free survival (PFS), brain metastasis progression, and overall survival. ;Primary end point(s): The primary efficacy endpoint is the objective response that is defined as a confirmed complete response (CR) or a confirmed partial response (PR) during the study period, as defined by the RECIST criteria. | — |
Countries
Sweden
Outcome results
None listed