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

Boehringer Ingelheim

Status and phase: Completed; Phase 1

Conditions: Breast Neoplasms; Stomach Neoplasms

Treatments: Drug: afatinib; Drug: trastuzumab; Drug: Herceptin

Study type: Interventional

Funder types: Industry

Identifiers

NCT01649271

2012-001753-10 (EudraCT Number)

1200.134

Details and patient eligibility

About

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.

Enrollment: 13 patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

---

13 participants in 3 patient groups

Phase Ia, group 1

Experimental group

Description:

afatinib escalating dose with 3-weekly trastuzumab

Treatment:

Drug: Herceptin

Drug: afatinib

Drug: Herceptin

Drug: afatinib

Drug: afatinib

Phase Ia, group 2

Experimental group

Description:

afatinib at MTD dose with weekly trastuzumab

Treatment:

Drug: Herceptin

Drug: afatinib

Drug: Herceptin

Drug: afatinib

Drug: afatinib

Phase Ib

Experimental group

Description:

afatinib at MTD level with 3-weekly trastuzumab

Treatment:

Drug: trastuzumab

Drug: afatinib

Drug: afatinib

Drug: afatinib