NCT00431067

Brief Summary

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.

Trial Health

85
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
41

participants targeted

Target at P25-P50 for phase_2

Geographic Reach
2 countries

12 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2006

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

February 2, 2007

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 5, 2007

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2009

Completed
4.4 years until next milestone

Results Posted

Study results publicly available

December 23, 2013

Completed
Last Updated

June 9, 2014

Status Verified

November 1, 2013

Enrollment Period

2.9 years

First QC Date

February 2, 2007

Results QC Date

August 8, 2013

Last Update Submit

June 3, 2014

Conditions

Breast Neoplasms

Outcome Measures

Primary Outcomes (1)

  • Objective Response (OR)

    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 Outcomes (4)

  • Progression Free Survival (PFS)

    From first dose of study medication to the occurrence of progression or death whichever came first, up to 34 month

  • Overall Survival (OS)

    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

    From first dose of study medication to time when OR measurement was taken.

  • Duration of Confirmed OR

    From first OR to time of progression or death

Study Arms (1)

BIBW 2992

EXPERIMENTAL

BIBW 2992 (Afatinib) once daily until progression

Drug: BIBW 2992

Interventions

BIBW 2992DRUG
Also known as: BIBW 2992 (Afatinib) once daily until progression
BIBW 2992

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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+).
  • 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.
  • Age 18 years or older.
  • Life expectancy of at least four (4) months.
  • Written informed consent that is consistent with ICH-GCP guidelines.
  • Eastern Cooperative Oncology Group (ECOG, R01-0787) performance Score 0, 1 or 2.
  • 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.
  • 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.
  • Patients must have recovered from previous surgery.
  • Patients must have measurable disease as defined by RECIST criteria.

You may not qualify if:

  • Active infectious disease.
  • Gastrointestinal disorders that may interfere with the absorption of the study drug or chronic diarrhea.
  • Serious illness or concomitant non-oncological disease considered by the investigator to be incompatible with the protocol.
  • 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.
  • Cardiac left ventricular function with resting ejection fraction \<50%.
  • Absolute neutrophil count (ANC) less than 1500 cells/mm3.
  • Platelet count less than 100 000 cells/mm3.
  • Bilirubin greater than 1.5 mg/dl (\>26 micromol /L, SI unit equivalent).
  • Aspartate amino transferase (AST) or alanine amino transferase (ALT) greater than three times the upper limit of normal.
  • Serum creatinine greater than 1.5 mg/dl (\>132 micromol/L, SI unit equivalent).
  • Women and men (and their partners) who are sexually active and unwilling to use a medically acceptable method of contraception.
  • Pregnancy or breast-feeding.
  • 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.
  • Prior treatment with an EGFR- or HER2 inhibiting drug (except trastuzumab).
  • Patients unable to comply with the protocol.
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (12)

1200.11.3 Boehringer Ingelheim Investigational Site

Scottsdale, Arizona, United States

Location

1200.11.7 Boehringer Ingelheim Investigational Site

Encinitas, California, United States

Location

1200.11.4 Boehringer Ingelheim Investigational Site

Santa Monica, California, United States

Location

1200.11.2 Boehringer Ingelheim Investigational Site

Tampa, Florida, United States

Location

1200.11.1 Boehringer Ingelheim Investigational Site

Boston, Massachusetts, United States

Location

1200.11.5 Boehringer Ingelheim Investigational Site

Chapel Hill, North Carolina, United States

Location

1200.11.4401 Boehringer Ingelheim Investigational Site

Bournemouth, United Kingdom

Location

1200.11.4402 Boehringer Ingelheim Investigational Site

Crownhill, Plymouth, United Kingdom

Location

1200.11.4406 Boehringer Ingelheim Investigational Site

Guildford, United Kingdom

Location

1200.11.4405 Boehringer Ingelheim Investigational Site

London, United Kingdom

Location

1200.11.4404 Boehringer Ingelheim Investigational Site

Poole, United Kingdom

Location

1200.11.4403 Boehringer Ingelheim Investigational Site

Truro, United Kingdom

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Afatinib

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

AmidesOrganic ChemicalsQuinazolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Results Point of Contact

Title
Boehringer Ingelheim Call Center
Organization
Boehringer Ingelheim Pharmaceuticals
clintriage.rdg@boehringer-ingelheim.com
1-800-243-0127

Study Officials

  • Boehringer Ingelheim

    Boehringer Ingelheim

    STUDY CHAIR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 2, 2007

First Posted

February 5, 2007

Study Start

September 1, 2006

Primary Completion

August 1, 2009

Last Updated

June 9, 2014

Results First Posted

December 23, 2013

Record last verified: 2013-11

Locations

GB(6)US(6)