Phase II Trial of BIBW 2992 in Patients With HER2-positive Metastatic Breast Cancer After Failure of Trastuzumab Therapy

June 3, 2014 updated by: Boehringer Ingelheim
The primary objective of this trial is to explore the efficacy of BIBW 2992 in HER2 positive metastatic breast cancer patients after failure of trastuzumab containing regimens.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

41

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • Bournemouth, United Kingdom
        • 1200.11.4401 Boehringer Ingelheim Investigational Site
      • Crownhill, Plymouth, United Kingdom
        • 1200.11.4402 Boehringer Ingelheim Investigational Site
      • Guildford, United Kingdom
        • 1200.11.4406 Boehringer Ingelheim Investigational Site
      • London, United Kingdom
        • 1200.11.4405 Boehringer Ingelheim Investigational Site
      • Poole, United Kingdom
        • 1200.11.4404 Boehringer Ingelheim Investigational Site
      • Truro, United Kingdom
        • 1200.11.4403 Boehringer Ingelheim Investigational Site
  • United States
    • Arizona
      • Scottsdale, Arizona, United States
        • 1200.11.3 Boehringer Ingelheim Investigational Site
    • California
      • Encinitas, California, United States
        • 1200.11.7 Boehringer Ingelheim Investigational Site
      • Santa Monica, California, United States
        • 1200.11.4 Boehringer Ingelheim Investigational Site
    • Florida
      • Tampa, Florida, United States
        • 1200.11.2 Boehringer Ingelheim Investigational Site
    • Massachusetts
      • Boston, Massachusetts, United States
        • 1200.11.1 Boehringer Ingelheim Investigational Site
    • North Carolina
      • Chapel Hill, North Carolina, United States
        • 1200.11.5 Boehringer Ingelheim Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion criteria:

Inclusion Criteria:

  1. Male or female patients with confirmed diagnosis of Stage IIIB or IV HER2-positive metastatic breast cancer(HER2 2+ and FISH positive or HER2 3+).
  2. Patients must have progressed following receipt of prior standard trastuzumab treatment or standard chemotherapy in conjunction with trastuzumab. Patients with visceral disease or rapid progression should not be included if they have not had previous chemotherapy in addition to trastuzumab. Patients who are intolerant to trastuzumab and who have received adequate chemotherapy and/or hormone therapy are eligible upon progression.
  3. Age 18 years or older.
  4. Life expectancy of at least four (4) months.
  5. Written informed consent that is consistent with ICH-GCP guidelines.
  6. Eastern Cooperative Oncology Group (ECOG, R01-0787) performance Score 0, 1 or 2.
  7. Patients should not have received treatment with chemotherapy or immune therapy within the last 4 weeks (2 weeks for trastuzumab). Patients should not have received treatment with hormone therapy within the last 2 weeks.
  8. Patients must have recovered from any therapy-related toxicities from previous chemo-, hormone-, immuno-, or radiotherapies to CTC less than or equal to Grade 1.
  9. Patients must have recovered from previous surgery.
  10. Patients must have measurable disease as defined by RECIST criteria.

Exclusion criteria:

Exclusion Criteria:

  1. Active infectious disease.
  2. Gastrointestinal disorders that may interfere with the absorption of the study drug or chronic diarrhea.
  3. Serious illness or concomitant non-oncological disease considered by the investigator to be incompatible with the protocol.
  4. Patients with active/symptomatic brain metastases. Patients with a history of treated brain metastases must have stable or normal MRI scan at screening and be at least three months post-radiation or surgery.
  5. Cardiac left ventricular function with resting ejection fraction <50%.
  6. Absolute neutrophil count (ANC) less than 1500 cells/mm3.
  7. Platelet count less than 100 000 cells/mm3.
  8. Bilirubin greater than 1.5 mg/dl (>26 micromol /L, SI unit equivalent).
  9. Aspartate amino transferase (AST) or alanine amino transferase (ALT) greater than three times the upper limit of normal.
  10. Serum creatinine greater than 1.5 mg/dl (>132 micromol/L, SI unit equivalent).
  11. Women and men (and their partners) who are sexually active and unwilling to use a medically acceptable method of contraception.
  12. Pregnancy or breast-feeding.
  13. Treatment with other investigational drugs; chemotherapy, immunotherapy, radiotherapy or hormone therapy (including LHRH agonists, or other hormones taken for breast cancer), or participation in another clinical study within the past 4 weeks before start of therapy or concomitantly with this study. Treatment with bisphosphonates is allowed.
  14. Prior treatment with an EGFR- or HER2 inhibiting drug (except trastuzumab).
  15. Patients unable to comply with the protocol.
  16. Active alcohol or drug abuse.
  17. Patients with history of other malignancy (except for appropriately treated superficial basal cell skin cancer and surgically cured cervical cancer in situ) unless free of disease for at least 3 years.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: BIBW 2992
BIBW 2992 (Afatinib) once daily until progression
Drug: BIBW 2992
Other Names:
  • BIBW 2992 (Afatinib) once daily until progression

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Objective Response (OR)
Time Frame: From first dose of study medication to response measurement, up to 34 month
Objective response (OR) including complete response (CR) and partial response (PR) according to the Response Evaluation Criteria in Solid Tumours (RECIST) criteria .
From first dose of study medication to response measurement, up to 34 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression Free Survival (PFS)
Time Frame: From first dose of study medication to the occurrence of progression or death whichever came first, up to 34 month
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 criteria.
From first dose of study medication to the occurrence of progression or death whichever came first, up to 34 month
Overall Survival (OS)
Time Frame: From first dose of study medication to death or to the last date the patient was known to be alive, up to 34 month
OS was defined as the time from first treatment to death or to the last date the patient was known to be alive.
From first dose of study medication to death or to the last date the patient was known to be alive, up to 34 month
Time to RECIST Tumour Reponse
Time Frame: From first dose of study medication to time when OR measurement was taken.
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 criteria.
From first dose of study medication to time when OR measurement was taken.
Duration of Confirmed OR
Time Frame: From first OR to time of progression or death
Duration of confirmed OR is measured from the time of first OR to the time of progression or death (or date of censoring for progression free survival).
From first OR to time of progression or death

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Boehringer Ingelheim

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2006

Primary Completion (Actual)

August 1, 2009

Study Registration Dates

First Submitted

February 2, 2007

First Submitted That Met QC Criteria

February 2, 2007

First Posted (Estimate)

February 5, 2007

Study Record Updates

Last Update Posted (Estimate)

June 9, 2014

Last Update Submitted That Met QC Criteria

June 3, 2014

Last Verified

November 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1200.11
  • 2007-004805-80 (EudraCT Number: EudraCT)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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