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Phase I Open Label Trial to Assess Safety of BIBW 2992 (Afatinib) in Combination With Herceptin® in Patients With HER2-positive Advanced Breast Cancer.

NCT00950742 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2025-02-10

Study results available
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Summary

Study to determine the Maximum Tolerated dose of BIBW 2992 given in combination with Herceptin®

Conditions

  • Breast Neoplasms

Interventions

DRUG

Trastuzumab

Load: 4mg/kg-maintain:2mg/kg/week

DRUG

BIBW 2992

Increased dose cohorts from low dose to MTD

Sponsors & Collaborators

Principal Investigators

  • Boehringer Ingelheim · Boehringer Ingelheim

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-08-01
Primary Completion
2013-10-01
Completion
2013-10-01

Countries

  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00950742 on ClinicalTrials.gov