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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-08-01

Study Completion Date

2013-10-01

Brief Summary

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

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Detailed Description

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Conditions

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Breast Neoplasms

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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BIBW 2992 + Trastuzumab

Find maximum tolerated dose of the non-marketed substance:BIBW 2992 given orally with fixed weekly infusion doses of 2mg/kg Herceptin. Escalating doses of BIBW 2992 starting at 20mg daily.

Group Type EXPERIMENTAL

Trastuzumab

Intervention Type DRUG

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

BIBW 2992

Intervention Type DRUG

Increased dose cohorts from low dose to MTD

Interventions

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Trastuzumab

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

Intervention Type DRUG

BIBW 2992

Increased dose cohorts from low dose to MTD

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Female patients aged \>18 years.
2. Advanced or metastatic breast cancer that over-expresses HER2 (immunohistochemistry 3+ or 2+ and gene amplification by FISH). Prior treatment with Herceptin® or Lapatinib® (in the adjuvant or metastatic settings) is permitted but not required.

Exclusion Criteria

Patients with untreated or symptomatic brain metastases. Prior treatment with EGFR targeting therapies or treatment with EGFR- or HER2 inhibiting drugs within the past four weeks before the start of therapy or concomitantly with this study.

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No