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

This study has been completed.
Information provided by (Responsible Party):
Boehringer Ingelheim Identifier:
First received: July 23, 2012
Last updated: June 28, 2016
Last verified: June 2016
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.

Condition Intervention Phase
Breast Neoplasms
Stomach Neoplasms
Drug: Herceptin
Drug: afatinib
Drug: trastuzumab
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase I Trial of Afatinib in Combination With 3 Weekly Trastuzumab in Patients With Tumours Overexpressing HER2. Once the MTD of Afatinib With 3 Weekly Trastuzumab Was Established the Safety of This Dose Will be Assessed Also in Combination With Weekly Trastuzumab.

Resource links provided by NLM:

Further study details as provided by Boehringer Ingelheim:

Primary Outcome Measures:
  • Phase Ib: Objective response according to RECIST criteria version 1.1. [ Time Frame: up to 40 months ]
  • Phase Ia: Determination of Maximum Tolerated Dose (MTD) of afatinib in combination with 3 weekly trastuzumab based on the occurence of DLTs during first treatment course. [ Time Frame: up to 21 days ]

Secondary Outcome Measures:
  • Phase Ib: Progression Free Survival (PFS). Phase Ib: Best Overall Response (Complete Response, Partial Response or stable disease). [ Time Frame: up to 40 months ]
  • Phase Ib: Clinical benefit: Objective Response and Stable disease according to RECIST criteria version 1.1. [ Time Frame: up to 40 months. ]
  • Phase Ia: Objective response according to the RECIST criteria version 1.1. [ Time Frame: up to 40 months. ]
  • Phase Ia: Best overall response according to the Recist criteria version 1.1. [ Time Frame: up to 40 months. ]
  • Phase Ib: Best Overall Response (Complete Response, Partial Response or stable disease) [ Time Frame: up to 40 months ]

Enrollment: 13
Study Start Date: July 2012
Study Completion Date: June 2016
Primary Completion Date: June 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Phase Ia, group 1
afatinib escalating dose with 3-weekly trastuzumab
Drug: Herceptin
Drug: afatinib
escalating dose
Experimental: Phase Ia, group 2
afatinib at MTD dose with weekly trastuzumab
Drug: afatinib
at MTD level
Drug: Herceptin
Experimental: Phase Ib
afatinib at MTD level with 3-weekly trastuzumab
Drug: trastuzumab
Drug: afatinib
at MTD level


Ages Eligible for Study:   18 Years to 99 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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).
  Contacts and Locations
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Please refer to this study by its identifier: NCT01649271

1200.134.33002 Boehringer Ingelheim Investigational Site
Dijon Cedex, France
1200.134.33003 Boehringer Ingelheim Investigational Site
Saint Herblain Cedex, France
1200.134.33001 Boehringer Ingelheim Investigational Site
Toulouse cedex 9, France
Sponsors and Collaborators
Boehringer Ingelheim
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
  More Information

Responsible Party: Boehringer Ingelheim Identifier: NCT01649271     History of Changes
Other Study ID Numbers: 1200.134
2012-001753-10 ( EudraCT Number: EudraCT )
Study First Received: July 23, 2012
Last Updated: June 28, 2016

Additional relevant MeSH terms:
Breast Neoplasms
Stomach Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Gastrointestinal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Antineoplastic Agents processed this record on May 23, 2017