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LUX-Breast 1: BIBW 2992 in HER2 Overexpressing Metastatic Breast Cancer Patients

2014-07-23 21:09:03 | BioPortfolio

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)

View Results

Links

Published on BioPortfolio: 2014-07-23T21:09:03-0400

Clinical Trials [2672 Associated Clinical Trials listed on BioPortfolio]

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...

Phase II Trial of BIBW 2992 in Patients With HER2-Positive Metastatic Breast Cancer After Failure of Trastuzumab Therapy

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.

Trial Exploring BIBW 2992 + Paclitaxel (Part A) and BIBW 2992 + Paclitaxel + Bevacizumab (Part B) in Patients With Advanced Solid Tumours

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 [3563 Associated PubMed Articles listed on BioPortfolio]

Phase I open-label study of afatinib plus vinorelbine in patients with solid tumours overexpressing EGFR and/or HER2.

This phase Ib study evaluated afatinib plus vinorelbine in patients with advanced solid tumours overexpressing epidermal growth factor receptor (EGFR) and/or human EGFR 2 (HER2).

Adjuvant vinorelbine and cisplatin after complete resection of stage II and III non-small cell lung cancer: long-term follow-up of our study of Japanese patients.

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...

MiR-129-5p Sensitizes the Response of Her-2 Positive Breast Cancer to Trastuzumab by Reducing Rps6.

Trastuzumab is an important treatment used for patients with Her-2-positive breast cancer, but an increasing incidence of trastuzumab resistance has been observed clinically during the past decade. Ab...

Survival outcomes for Australian women receiving trastuzumab for HER2-positive metastatic breast cancer following (neo)adjuvant trastuzumab: a national population-based observational study (2006-2014).

Patients treated with (neo)adjuvant trastuzumab who relapse and receive trastuzumab for metastatic breast cancer (MBC) are a growing population with little outcome data given their exclusion from most...

Ado-trastuzumab emtansine (T-DM1) in HER2+ advanced breast cancer patients: does pretreatment with pertuzumab matter?

We evaluated the outcomes of patients treated with ado-trastuzumab emantasine (T-DM1) after first-line pertuzumab/trastuzumab, compared with those receiving a trastuzumab-only-based regimen.

Medical and Biotech [MESH] Definitions

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.

Breast neoplasms that do not express ESTROGEN RECEPTORS; PROGESTERONE RECEPTORS; and do not overexpress the NEU RECEPTOR/HER-2 PROTO-ONCOGENE PROTEIN.

Any neoplasms of the male breast. These occur infrequently in males in developed countries, the incidence being about 1% of that in females.

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.

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.

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