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

Boehringer Ingelheim

Status and phase: Completed; Phase 1

Conditions: Breast Neoplasms

Treatments: Drug: BIBW 2992; Drug: Trastuzumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT00950742

2009-010003-89 (EudraCT Number)

1200.68

Details and patient eligibility

About

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

Enrollment: 18 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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18 participants in 1 patient group

BIBW 2992 + Trastuzumab

Experimental group

Description:

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.

Treatment:

Drug: Trastuzumab

Drug: BIBW 2992