Conditions: Breast Neoplasms Stomach Neoplasms
Allocation: NON_RANDOMIZED | Intervention model: SINGLE_GROUP
Enrollment: 13
Healthy volunteers: no

Brief 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.

Detailed description:

Arms:
arm 1: afatinib escalating dose with 3-weekly trastuzumab arm 2: afatinib at MTD dose with weekly trastuzumab arm 3: afatinib at MTD level with 3-weekly trastuzumab

Interventions: intervention 1: Herceptin intervention 2: afatinib intervention 3: trastuzumab intervention 4: Herceptin intervention 5: afatinib intervention 6: afatinib
Intervention descriptions: intervention 1: 3-weekly intervention 2: at MTD level intervention 3: 3-weekly intervention 4: weekly intervention 5: at MTD level intervention 6: escalating dose

Protocol document: