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Completed

NCT Number: NCT00950742

Phase I Open Label Trial to Assess Safety of BIBW 2992 (Afatinib) in Combination With Herceptin® in Patients With HER2-positive Advanced Breast Cancer.

Study to determine the Maximum Tolerated dose of BIBW 2992 given in combination with Herceptin®

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Key information

Conditions

Breast Neoplasms Breast Diseases Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1

Primary location

1200.68.44001 Boehringer Ingelheim Investigational Site, Brighton, United Kingdom

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Female patients aged >18 years.
  • Advanced or metastatic breast cancer that over-expresses HER2 (immunohistochemistry 3+ or 2+ and gene amplification by FISH). Prior treatment with Herceptin® or Lapatinib® (in the adjuvant or metastatic settings) is permitted but not required.

Exclusion criteria

Patients with untreated or symptomatic brain metastases. Prior treatment with EGFR targeting therapies or treatment with EGFR- or HER2 inhibiting drugs within the past four weeks before the start of therapy or concomitantly with this study.

Treatment and study plan

Trastuzumab

Drug

Load: 4mg/kg-maintain:2mg/kg/week

BIBW 2992

Drug

Increased dose cohorts from low dose to MTD

Primary outcomes

  1. Number of Participants With Dose Limiting Toxicities (DLT)

    Time frame: 28 days

    Number of participants with DLT in the first cycle (28 days) for the determination of the maximum tolerated dose (MTD). Important Limitations and Caveats are provided in the respective section.

  2. Maximum Tolerated Dose (MTD) of Afatinib in Combination With Herceptin(R)

    Time frame: 28 days

    The MTD was defined as the highest dose at which no more than 1 of 6 patients experienced DLT. It was determined using a standard 3 + 3 dose escalation cohort design. To confirm the MTD, the MTD cohort was to be expanded to 18 patients with no more than 3/18 patients experiencing a DLT. Please refer to CAVEATs and Limitations.

Secondary outcomes

  1. Number of Patients With Objective Response (OR)

    Time frame: Tumor assessment was performed at screening and every 2nd cycle until earliest time of progression, death or end of treatment.

    Objective tumor response based on response evaluation criteria in solid tumors (RECIST) version 1.1. OR is defined as complete response (CR) or partial response (PR).

  2. Number of Patients With Best Overall Response

    Time frame: Tumor assessment was performed at screening and every 2nd cycle until earliest time of progression, death or end of treatment.

    Best overall response based on response evaluation criteria in solid tumors (RECIST) version 1.1. Best overall response is defined as complete response (CR), partial response (PR), stable disease (SD), progressive disease (PD) or not evaluable.

  3. Progression Free Survival (PFS)

    Time frame: Baseline until disease progression, death or data cut-off.

    PFS is defined as time from randomisation to disease progression or death whichever occurs first. Assessed by central independent review according to the response evaluation criteria in solid tumors (RECIST 1.1). Median time results from unstratified Kaplan-Meier estimates.

  4. Summary of Concentration of Afatinib in Plasma

    Time frame: 0.05 hours (h) before dosing and 0.5-1h, 2h, 3h, 4h, 5h, 6h, 8h after dosing

    Pre-dose Concentrations of Afatinib in Plasma at Steady State on Days 8, 15 and 29 (Cpre,ss,8, Cpre,ss,15 and Cpre,ss,29) and Maximum Concentration of Afatinib in Plasma at Steady State (Cmax,ss).

  5. Time From Dosing to the Maximum Concentration of Afatinib in Plasma at Steady State (Tmax,ss)

    Time frame: 0.05 hours (h) before dosing and 0.5-1h, 2h, 3h, 4h, 5h, 6h, 8h after dosing

    tmax,ss represents the time from dosing to the maximum concentration of afatinib in plasma at steady state

  6. Summary of Concentration of Herceptin in Plasma

    Time frame: 0.05 hours (h) before dosing and 0.5-1h, 2h, 3h, 4h, 5h, 6h, 8h after dosing

    Pre-dose Concentrations of Herceptin in Plasma on Days 8, 15 and 29 (Cpre,8, Cpre,15 and Cpre,29) and Maximum Concentration of Herceptin in Plasma on Days 1, 15 and 29 (Cmax,1, Cmax,15 and Cmax,29).

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Registry information

Official study title

Phase I Open Label Trial to Assess Safety of BIBW 2992 in Combination With Herceptin® in Patients With HER2-positive Advanced Breast Cancer.

Important dates

Study start
2009
Primary completion
2013
Study completion
2013
First posted
Aug 3, 2009
Registry last updated
Feb 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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