LUX-Breast 1: BIBW 2992 in HER2 Overexpressing Metastatic Breast Cancer Patients
Summary
The main objective of the trial is to assess the efficacy of BIBW 2992 in combination with vinorelbine (Arm A) over trastuzumab, which is continued beyond progression in combination with vinorelbine (Arm B) in first and second line metastatic breast cancer patients
Study Design
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Conditions
Breast Neoplasms
Intervention
BIBW 2992, trastuzumab, vinorelbine, vinorelbine
Location
1200.75.32004 Boehringer Ingelheim Investigational Site
Antwerpen
Belgium
Status
Not yet recruiting
Source
Boehringer Ingelheim Pharmaceuticals
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT01125566
- Information obtained from ClinicalTrials.gov on July 15, 2010
Published on BioPortfolio: 2014-07-23T21:09:03-0400
Clinical Trials
6 Weeks Treatment of Locally Advanced Breast Cancer With BIBW 2992 or Lapatinib or Trastuzumab
An open-label, randomized three-arm Phase II trial to explore the efficacy of BIBW 2992 as a single agent versus lapatinib versus trastuzumab in patients with HER2-positive treatment-naïv...
The primary objective of this trial is to explore the efficacy of BIBW 2992 in HER2 positive metastatic breast cancer patients after failure of trastuzumab containing regimens.
The main purpose of this study is to assess the optimum dose of the following medications when they are given together: - BIBW 2992 and paclitaxel (Taxol) - BIBW 2992 and p...
BIBW 2992 and Letrozole in Hormonoresistant Metastatic Breast Cancer
Progression-free rate after 16 weeks of BIBW 2992 administration in association with letrozole
Vinorelbine With or Without Trastuzumab in Treating Women With Progressive Metastatic Breast Cancer
RATIONALE: Drugs used in chemotherapy, such as vinorelbine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclo...
PubMed Articles
The aim of this study was to record the opinions of Italian oncologists about the use of oral vinorelbine administered metronomically in patients with advanced breast cancer.
We reported previously a phase II study of adjuvant chemotherapy consisting of four cycles of vinorelbine (25 mg/m) and cisplatin (40 mg/m), given on days 1 and 8, every 4 weeks, to Japanese patien...
LMO4 mediates trastuzumab resistance in HER2 positive breast cancer cells.
Breast cancer is the leading cause of cancer-related mortality in women worldwide. Trastuzumab (Herceptin) is an effective antibody drug for HER2 positive breast cancer; or acquired trastuzumab resis...
For human epidermal growth factor receptor 2 (HER2)-positive metastatic breast cancer (MBC) with progression on trastuzumab-based therapy, continuing trastuzumab beyond progression and switching to la...
Cardiac toxicity with a decrease of the left ventricular ejection fraction (LVEF) is the main side effect induced by trastuzumab. This study reports the fluctuation of LVEF over the 12 months of adjuv...
Medical and Biotech [MESH] Definitions
Trastuzumab
A humanized monoclonal antibody against the ERBB-2 RECEPTOR (HER2). As an ANTINEOPLASTIC AGENT, it is used to treat BREAST CANCER where HER2 is overexpressed.
Triple Negative Breast Neoplasms
Breast neoplasms that do not express ESTROGEN RECEPTORS; PROGESTERONE RECEPTORS; and do not overexpress the NEU RECEPTOR/HER-2 PROTO-ONCOGENE PROTEIN.
Breast Neoplasms, Male
Any neoplasms of the male breast. These occur infrequently in males in developed countries, the incidence being about 1% of that in females.
Neoplasms, Ductal, Lobular, And Medullary
Neoplasms, usually carcinoma, located within the center of an organ or within small lobes, and in the case of the breast, intraductally. The emphasis of the name is on the location of the neoplastic tissue rather than on its histological type. Most cancers of this type are located in the breast.
Inflammatory Breast Neoplasms
Metastatic breast cancer characterized by EDEMA and ERYTHEMA of the affected breast due to LYMPHATIC METASTASIS and eventual obstruction of LYMPHATIC VESSELS by the cancer cells.
