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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


Phase 2
18 Years
N/A
Not Enrolling
Female
Breast Neoplasms

Thank you

Trial Information

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


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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Outcome Measure:

Objective response

Outcome Time Frame:

19 months

Safety Issue:

No

Principal Investigator

Boehringer Ingelheim

Investigator Role:

Study Chair

Investigator Affiliation:

Boehringer Ingelheim Pharmaceuticals

Authority:

Belgium: Federal Agency for Medicines and Health Products, FAMHP

Study ID:

1200.10

NCT ID:

NCT00425854

Start Date:

November 2006

Completion Date:

Related Keywords:

  • Breast Neoplasms
  • Breast Neoplasms
  • Neoplasms

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