Phase I Trial of Afatinib and Trastuzumab in HER2 Overexpressing Cancer.

• Status: Completed
• Trial end date: 2016-06-23
• Target enrollment: 0
• Participant gender: All

Summary

The aim of the study is to determine the Maximum Tolerated Dose (MTD) of afatinib in combination with 3-weekly trastuzumab in HER2 overexpressing cancer and to assess the efficacy of afatinib given at the MTD dosage, with 3-weekly trastuzumab in HER2 overexpressing metastatic breast cancer.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Boehringer Ingelheim
• Treatments: Afatinib; Trastuzumab

Criteria

Inclusion criteria:

1. Patients aged 18 years and older

2. Patients with cancers overexpressing HER2 by Immunohistochemistry test( IHC) 3+ and/or IHC 2+ with positive gene amplification by FISH (confirmation on archived tissue needed)

3. Written informed consent that is consistent with ICH-GCP guidelines.

4. Patients must be eligible for treatment with trastuzumab.

5. Patients must have adequate organ function (kidney, liver, bone marrow, cardiac)

6. Eastern Cooperative Oncology Group (ECOG) = 0 or 1.

7. Measurable disease according to RECIST 1.1 (Phase Ib).

Exclusion criteria:

1. Active brain metastases.

2. Prior treatment with erbB family targeting therapies within the past four weeks before start of therapy or concomitantly with the trial other than trastuzumab and/or lapatinib.

3. Patients having more than 2 lines of chemotherapy for the treatment of metastatic breast cancer (Phase Ib).