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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT00431067
First received: February 2, 2007
Last updated: June 3, 2014
Last verified: November 2013
  Purpose

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.


Condition Intervention Phase
Breast Neoplasms
Drug: BIBW 2992
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Trial of BIBW 2992 in Patients With HER2-positive Metastatic Breast Cancer After Failure of Trastuzumab Therapy

Resource links provided by NLM:


Further study details as provided by Boehringer Ingelheim:

Primary Outcome Measures:
  • Objective Response (OR) [ Time Frame: From first dose of study medication to response measurement, up to 34 month ] [ Designated as safety issue: No ]
    Objective response (OR) including complete response (CR) and partial response (PR) according to the Response Evaluation Criteria in Solid Tumours (RECIST) criteria .


Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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.

  • 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 ] [ Designated as safety issue: No ]
    OS was defined as the time from first treatment to death or to the last date the patient was known to be alive.

  • Time to RECIST Tumour Reponse [ Time Frame: From first dose of study medication to time when OR measurement was taken. ] [ Designated as safety issue: No ]
    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.

  • Duration of Confirmed OR [ Time Frame: From first OR to time of progression or death ] [ Designated as safety issue: No ]
    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).


Enrollment: 41
Study Start Date: September 2006
Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: BIBW 2992
BIBW 2992 (Afatinib) once daily until progression
Drug: BIBW 2992
Other Name: BIBW 2992 (Afatinib) once daily until progression

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00431067

Locations
United States, Arizona
1200.11.3 Boehringer Ingelheim Investigational Site
Scottsdale, Arizona, United States
United States, California
1200.11.7 Boehringer Ingelheim Investigational Site
Encinitas, California, United States
1200.11.4 Boehringer Ingelheim Investigational Site
Santa Monica, California, United States
United States, Florida
1200.11.2 Boehringer Ingelheim Investigational Site
Tampa, Florida, United States
United States, Massachusetts
1200.11.1 Boehringer Ingelheim Investigational Site
Boston, Massachusetts, United States
United States, North Carolina
1200.11.5 Boehringer Ingelheim Investigational Site
Chapel Hill, North Carolina, United States
United Kingdom
1200.11.4401 Boehringer Ingelheim Investigational Site
Bournemouth, United Kingdom
1200.11.4402 Boehringer Ingelheim Investigational Site
Crownhill, Plymouth, United Kingdom
1200.11.4406 Boehringer Ingelheim Investigational Site
Guildford, United Kingdom
1200.11.4405 Boehringer Ingelheim Investigational Site
London, United Kingdom
1200.11.4404 Boehringer Ingelheim Investigational Site
Poole, United Kingdom
1200.11.4403 Boehringer Ingelheim Investigational Site
Truro, United Kingdom
Sponsors and Collaborators
Boehringer Ingelheim
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
  More Information

Additional Information:
No publications provided

Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT00431067     History of Changes
Other Study ID Numbers: 1200.11, 2007-004805-80
Study First Received: February 2, 2007
Results First Received: August 8, 2013
Last Updated: June 3, 2014
Health Authority: Great Britain: EMEA
United States: Food and Drug Administration

Additional relevant MeSH terms:
Breast Neoplasms
Breast Diseases
Neoplasms
Neoplasms by Site
Skin Diseases
Trastuzumab
Antineoplastic Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014