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 -

• Conditions: HER2-negative metastatic breast cancer after failure of no more than two chemotherapy regimen in two cohorts of patients; Two Cohorts: Cohort A: Triple negative metastatic breast cancer, i.e. HER2-negative, estrogen-receptor-negative and progesterone receptor negative; Cohort B:HER2-negative, estrogen-receptor-positive and/or progesterone-receptor positive; MedDRA version: 8.1Level: LLTClassification code 10027475Term: Metastatic breast cancer

• Registration Number: EUCTR2006-002018-36-BE
• Lead Sponsor: SCS Boehringer Ingelheim Comm.V

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-10-20
• Last Update Posted: 7 October 2014

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Female
• Target Recruitment: 60

Inclusion Criteria

Inclusion criteria for both cohorts of HER2-negative patients
1. Female Patients age 18 years or older.
2. Patients with histologically proven breast cancer, who failed or relapsed after no more than two lines of chemotherapy, including adjuvant.
3. HER2-negative patients (HER2 1+ or negative, or Her2 2+ and FISH negative if known).
4. Patients with at least one tumour lesion that can accurately be measured by magnetic resonance imaging (MRI), computed tomography (CT) or X-ray in at least one dimension (longest diameter to be recorded) as = 20 mm with conventional techniques or as = 10 mm with spiral CT scan.
5. Patients must have tumour samples available for EGFR-testing.
6. Life expectancy of at least six (6) months.
7. Written informed consent that is consistent with ICH-GCP guidelines and local law.
8. Eastern Cooperative Oncology Group (ECOG) performance score 0 or 1.
9. Evidence of metastatic breast cancer

Additional inclusion criteria for Cohort A

10. HR-negative patients; ER-status and PgR-status must be assessed by IHC.

Additional inclusion criteria for Cohort B

10. ER-and/or PgR-positive patients; ER-status and PgR-status must be assessed by IHC.

11. Patients must sign informed consent form for pharmakogenetic analyses prior to analysis of EGFR/EGFR-ligand overexpression on mRNA basis.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Active infectious disease.
2. Gastrointestinal disorders that may interfere with the absorption of the study drug or chronic diarrhoea.
3. Serious illness, concomitant non-oncological disease or mental problems 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 cerebral 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/mm3.
7. Platelet count less than 100 000/mm3.
8. Bilirubin greater than 1.5 mg /dl (>26 µmol /L, SI unit equivalent).
9. Aspartate amino transferase (AST) or alanine amino transferase (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.
10. Serum creatinine greater than 1.5 mg/dl (>132 µmol/L, SI unit equivalent).
11. Patients 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; other anti-cancer-therapy, e.g. chemotherapy, immunotherapy, radiotherapy or hormone therapy (including LHRH agonists, or other endocrine therapies/hormones taken for breast cancer), concomitantly with therapy on this study. Previous small field radiation or endocrine therapy during the past two weeks, myelosuppressive chemotherapy within the past four weeks, and therapy with mitomycin C during the past six weeks prior to the first treatment with the trial drug. Concurrent treatment with biphosphonates is allowed.
14. Previous treatment with trastuzumab, EGFR-, or EGFR/HER2-inhibitors.
15. Patients unable to comply with the protocol.
16. Active alcohol or drug abuse.
17. Patients who have not recovered from any therapy-related toxicities of previous chemo-, hormone-, immuno-, or radiotherapies at the time of the first administration of the trial drug.
18. Other malignancy within the past 5 years

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified