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Phase I Trial of Afatinib and Trastuzumab in HER2 Overexpressing Cancer. | Clinical Trials | Clareo Health

COMPLETEDPHASE1

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

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.

NCT01649271•Boehringer Ingelheim

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - 99 years

Sex

ALL

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).

Locations (3)

CTR Georges-François Leclerc

Dijon, France

CTR René Gauducheau

Saint-Herblain, France

INS Claudius Regaud

Toulouse, France

Key Dates

Start Date

July 23, 2012

Primary Completion Date

June 23, 2016

Completion Date

June 23, 2016

Last Updated

February 11, 2025

Enrollment

ACTUAL participants

Conditions

Breast NeoplasmsStomach Neoplasms

Interventions

Herceptin

DRUG

afatinib

DRUG

trastuzumab

DRUG

Herceptin

DRUG

afatinib

DRUG

afatinib

DRUG

ML Score Prediction of Cardiotoxicity in Cancer Patients Receiving Anthracycline Chemotherapy or HER2-Targeted Therapies

NCT07191730

CardiotoxicityHeart Failure+2 more

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RECRUITINGPHASE3

A Study of Sacituzumab Tirumotecan (MK-2870) as a Single Agent and in Combination With Pembrolizumab (MK-3475) Versus Treatment of Physician's Choice in Participants With HR+/HER2- Unresectable Locally Advanced or Metastatic Breast Cancer (MK-2870-010)

NCT06312176

Breast Neoplasms

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 11, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

ML Score Prediction of Cardiotoxicity in Cancer Patients Receiving Anthracycline Chemotherapy or HER2-Targeted Therapies

A Study of Sacituzumab Tirumotecan (MK-2870) as a Single Agent and in Combination With Pembrolizumab (MK-3475) Versus Treatment of Physician's Choice in Participants With HR+/HER2- Unresectable Locally Advanced or Metastatic Breast Cancer (MK-2870-010)

Study of Patritumab Deruxtecan Plus Pembrolizumab With Other Anticancer Agents in Participants With High-Risk Early-Stage Triple-Negative or Hormone Receptor-Low Positive/HER-2 Negative Breast Cancer (MK-1022-010, HERTHENA-Breast-03)

Evaluation of Clinical Efficacy of Augmented Reality (AR)-Based Breast Cancer Medical Imaging Solution (SKIA-Breast) Localization Method in Breast Cancer Patients

Anti-Mesothelin TNaive/SCM hYP218 (TNhYP218) CAR T Cells in Participants With Mesothelin-Expressing Solid Tumors Including Mesothelioma

Dissemination of BREASTChoice AIM1-B