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Single-arm, Open-label, Multicentre Phase II Study Evaluating the Efficacy and Safety of BIBW 2992 (Afatinib) in Combination With Vinorelbine for the Treatment of Patients With Metastatic Breast Cancer With Intermediate HER2 Expression (HER2 2+ by Immunohistochemistry, Fluorescence In-situ Hybridisation (FISH) Negative) After Failure of First-line Therapy in the Metastatic Setting and Having Been Pre-treated With Anthracyclines


Phase 2
18 Years
N/A
Open (Enrolling)
Female
Carcinoma Breast Stage IV

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Trial Information

Single-arm, Open-label, Multicentre Phase II Study Evaluating the Efficacy and Safety of BIBW 2992 (Afatinib) in Combination With Vinorelbine for the Treatment of Patients With Metastatic Breast Cancer With Intermediate HER2 Expression (HER2 2+ by Immunohistochemistry, Fluorescence In-situ Hybridisation (FISH) Negative) After Failure of First-line Therapy in the Metastatic Setting and Having Been Pre-treated With Anthracyclines


Inclusion Criteria:



- Female patients ≥ 18 years

- Histologically confirmed diagnosis of intermediate HER2-overexpressing breast cancer

- Stage IV metastatic disease

- Must have received anthracycline-based chemotherapy for adjuvant treatment of breast
cancer or first-line treatment of metastatic breast cancer

- Must have received one first-line chemotherapy for metastatic breast cancer

- Must have (archived) tumour tissue sample available for central re- assessment of
HER2 status and prove to be intermediate HER2-positive. HER2 intermediate status is
defined as IHC 2+ and FISH-negativity.

- Must have at least one measurable lesion according to RECIST 1.1. Patient with only
skin lesions will not be eligible.

- Eastern Cooperative Oncology Group (ECOG) score of 0 or 1.

- Life expectancy of at least six (6) months.

- Written informed consent that is consistent with ICH-GCP guidelines.

- Must be eligible for treatment with BIBW 2992 and vinorelbine.

Exclusion Criteria:

- 1. Prior treatment with EGFR/HER2-targeted tyrosine kinase inhibitors, i.e. lapatinib

- Prior treatment with vinorelbine

- Known pre-existing interstitial lung disease

- Radiotherapy, chemotherapy, hormone therapy, immunotherapy or surgery (other than
biopsy) within 4 weeks (2 weeks for hormone therapy) prior to start of treatment with
BIBW 2992 and vinorelbine.

- Active brain metastases

- Any other current malignancy or malignancy diagnosed within the past five (5) years
(other than non-melanomatous skin cancer and in situ cervical cancer).

- Significant or recent acute gastrointestinal disorders with diarrhoea as a major
symptom, e.g. Crohn's disease, malabsorption or CTC grade ≥ 2 diarrhoea of any
aetiology.

- History or presence of clinically relevant cardiovascular abnormalities such as
uncontrolled hypertension, congestive heart failure NYHA classification of ≥3,
unstable angina or poorly controlled arrhythmia. Myocardial infarction within 6
months prior to start of study treatment.

- Cardiac left ventricular function with resting ejection fraction of less than 50 %.

- Any other concomitant serious illness or organ system dysfunction which in the
opinion of the investigator would either compromise patient safety or interfere with
the evaluation of the safety of the test drug.

- Laboratory values according to specified ranges.

- Women of childbearing potential, unwilling to use a medically acceptable method of
contraception during the trial.

- Pregnancy or breast-feeding.

- Patients unable to comply with the protocol.

- Known hepatitis B infection, known hepatitis C infection or known HIV carrier.

- Known or suspected active drug or alcohol abuse.

- Requirement for treatment with any of the prohibited concomitant medications

- Any contraindications for therapy with vinorelbine or BIBW 2992.

- Known hypersensitivity to BIBW 2992 or the excipients of any of the trial drugs.

- Use of any investigational drug within 4 weeks of start of treatment.

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Progression-free survival based on tumor imaging according to RECIST 1.1 criteria.

Outcome Description:

The primary objective is to determine the 6-month Progression free survival rate of BIBW 2992 and vinorelbine i.v. in patients with metastatic, HER2 IHC 2+, HER2 FISH-negative breast cancer. The analysis will be based upon the evaluation of tumour imaging. Disease progression will be evaluated according to the RECIST 1.1 criteria.

Outcome Time Frame:

6 months defined as the time from the date of treatment start

Safety Issue:

No

Principal Investigator

Joachim Bischoff, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Otto-von-Guericke-Universität Magdeburg, Germany

Authority:

Germany: Federal Institute for Drugs and Medical Devices

Study ID:

1200.137

NCT ID:

NCT01531764

Start Date:

July 2012

Completion Date:

April 2016

Related Keywords:

  • Carcinoma Breast Stage IV
  • Metastatic breast cancer
  • intermediate HER2 expression
  • Afatinib
  • Breast Neoplasms
  • Carcinoma

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