A phase II, randomized trial with single agent trastuzumab or lapatinib in women with metastatic breast cancer iperexpressing HER2 - ND
- Conditions
- women with metastatic breast cancer iperexpressing HER2MedDRA version: 9.1Level: LLTClassification code 10065430MedDRA version: 9.1Level: LLTClassification code 10055113
- Registration Number
- EUCTR2008-001916-18-IT
- Lead Sponsor
- AZIENDA OSPEDALIERA ORDINE MAURIZIANO
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- Female
- Target Recruitment
- Not specified
age between 18 and 75 years; Histologically o citologically confirmed diagnosis of metastatic disease; HER2 iperexpression assessed by FISH; no prior chemotherapy for metastatic or locally recurrent disease; for patients undergoing hormonal treatment for metastatic disease, confirmation of progression is required and performed according to RECIST criteria; increase in the sum of major diameters of at leasrt 20%, or appearance of new metastatic lesions or progression of existing non-target lesions; at least one monodimensionally measurable lesion; patients with involvement of NCS are admitted if: the lesion(s) has/have been radically resected - radiotherapy on the brain lesion(s) has been performed and complete remission can be documented by TC or RMN; at least 4 week`s interval from end of radiotherapy, hormono- or immuno-therapy and enrollment into the protocol; Performance Status (ECOG)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
prior chemotherapy for metastatic disease; prior treatment with lapatinib; prior therapy with mono- or policlonal antibodies for metastatic disease; bone involvement or pleural effusion/ascites as unique localization of disease; administration of any experimental drug within 4 weeks prior beginning of treatment;
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: - to determine tumor response rate to first line treatment with single agent Trastuzumab or Lapatinib in women with metastatic breast cancer iperexpressing HER2;Secondary Objective: 1) assessment of time to progression (TTP) and duration of response in patients treated with trastuzumab 2) evaluation of biomolecular factors predictive of resistance or susceptibility to treatment with trastuzumab or lapatinib;Primary end point(s): assessment of tumor response rate in terms of proportion of patients who have obtained complete remission )CR), partial remisison (PR) o minimal remission (MR) according to RECIST criteria
- Secondary Outcome Measures
Name Time Method