Skip to main content
OpenTrials
Completed

NCT Number: NCT00425854

An Open Label Phase II Trial of BIBW 2992 in Patients With HER2-negative Metastatic Breast Cancer

The purpose of this trial is to evaluate the efficacy, safety and pharmacokinetics of BIBW 2992, a dual, irreversible EGFR- and HER2-inhibitor, in two cohorts of patients with HER2-negative breast cancer after failure of no more than three regimen of prior chemotherapy.

Completed

Looking for future studies?

Notify Me

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 2

Primary location

1200.10.3201 Boehringer Ingelheim Investigational Site, Brussels, Belgium

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

Inclusion criteria

  • Female patients age 18 years or older
  • Histologically proven breast cancer after failure or relapse of no more than three lines of chemotherapy including adjuvant, irrespective of prior hormone therapy metastatic disease (stage IV);
  • HER2-negative patients (HER2 1+ or negative, or HER2 2+ and FISH negative)
  • At least one measurable tumour lesion (RECIST);
  • Availability of tumour samples
  • Written informed consent that is consistent with ICH-GCP guidelines and local law
  • Eastern Cooperative Oncology Group (ECOG, R01-0787) performance score 0 - 2.

Exclusion criteria

Exclusion criteria

  • Active infectious disease
  • Gastrointestinal disorders that may interfere with the absorption of the study drug or chronic diarrhoea
  • Serious illness, concomitant non-oncological disease or mental problems considered by the investigator to be incompatible with the protocol
  • Active/symptomatic brain metastases
  • Cardiac left ventricular function with resting ejection fraction < 50% (below upper limit of normal)
  • ANC less than 1500/mm3 platelet count less than 100 000/mm3
  • Bilirubin greater than 1.5 mg /dl (>26 and#61549 mol /L, SI unit equivalent)
  • AST and ALT greater than 2.5 times the upper limit of normal or greater 5 times the upper limit of normal in case of known liver metastases
  • Serum creatinine greater than 1.5 mg/dl (>132 and#61549 mol/L, SI unit equivalent)
  • Patients who are sexually active and unwilling to use a medically acceptable method of contraception
  • Pregnancy or breast-feeding
  • Concomitant treatment with other investigational drugs or other anti-cancer-therapy during this study and/or during the past two/four weeks, prior to the first treatment with the trial drug. Concurrent treatment with biphosphonates is allowed
  • Previous treatment with trastuzumab, EGFR-, or EGFR/HER2-inhibitors patients unable to comply with the protocol
  • Active alcohol or drug abuse
  • Other malignancy within the past 5 years

Treatment and study plan

BIBW 2992

Drug

high dose once daily

Primary outcomes

  1. Objective Response (OR)

    Time frame: Tumour assessments were performed at screening, week 8, week 16, week 24, and every 8 weeks thereafter.

    OR is defined as complete response (CR) and partial response (PR) and was assessed according to the Response Evaluation Criteria in Solid Tumours version 1.0 (RECIST). OR was primary endpoint only for Cohort B.

  2. Clinical Benefit (CB)

    Time frame: Tumour assessments were performed at screening, week 8, week 16, week 24, and every 8 weeks thereafter.

    CB was defined as CR, PR or stable disease (SD) for a minimum of 4 months (modified CB) and was assessed according to RECIST 1.0 criteria. CB was primary endpoint only for Cohort A.

Secondary outcomes

  1. Clinical Benefit (CB)

    Time frame: Tumour assessments were performed at screening, week 8, week 16, week 24, and every 8 weeks thereafter.

    CB was defined as CR, PR or stable disease (SD) for a minimum of 4 months (modified CB) and was assessed according to RECIST 1.0 criteria. CB was secondary endpoint only for Cohort B as it was primary endpoint for Cohort A.

  2. Time to OR

    Time frame: Tumour assessments were performed at screening, week 8, week 16, week 24, and every 8 weeks thereafter.

    The time to OR was the duration from the first treatment to the time when the measurement criteria for CR and/or PR were met according to RECIST 1.0 criteria.

  3. Duration of OR

    Time frame: Tumour assessments were performed at screening, week 8, week 16, week 24, and every 8 weeks thereafter.

    Duration of OR was measured from the time the criteria for CR or PR (whichever was documented first) were first met until the first date that progressive disease or death was objectively documented.

  4. Progression-free Survival (PFS)

    Time frame: Tumour assessments were performed at screening, week 8, week 16, week 24, and every 8 weeks thereafter.

    PFS was defined as the time from the first treatment to the occurrence of tumour progression or death, whichever came first. It was assessed according to RECIST 1.0 criteria as well as by the investigators assessment. Median time results from unstratified Kaplan-Meier estimates.

  5. Overall Survival (OS)

    Time frame: From randomisation to end of follow-up.

    OS is defined as time from randomisation to death.

  6. Significant Change in Cardiac Left Ventricular Ejection Fraction (LVEF)

    Time frame: Baseline and last assessment

    LVEF as measured by echocardiography or Multiple Gated Acquisition (MUGA) scan. MUGA scan is an useful noninvasive tool for assessing the function of the heart. Significant change in LVEF values was defined as >=20 percent decrease from baseline or to below lower limit of normal, which was defined as 50 percent.

  7. Best Change From Baseline in ECOG Performance Status

    Time frame: baseline till end of treatment

    Best change from baseline in ECOG (Eastern Cooperative Oncology Group) performance status. ECOG is measured as score between 0 (fully active) and 5 (dead).

  8. Pre-dose Concentration of Afatinib in Plasma at Steady State on Day 29 (Cpre,ss,29)

    Time frame: day 29

    Cpre,ss,29 represents the pre-dose concentration of afatinib in plasma at steady state on day 29.

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Registry information

Official study title

An Open Label Phase II Trial to Assess the Efficacy and Safety of a Once Daily Oral Dose of 50 mg BIBW 2992 in Two Cohorts of Patients With HER2-negative Metastatic Breast Cancer After Failure of no More Than Two Chemotherapy Regimen

Important dates

Study start
2006
Primary completion
2009
First posted
Jan 23, 2007
Registry last updated
Dec 31, 2013

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

View the official ClinicalTrials.gov record (opens in a new tab)

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.