LUX-Breast 1: BIBW 2992 (Afatinib) in HER2-positive Metastatic Breast Cancer Patients After One Prior Herceptin Treatment

Boehringer Ingelheim

Status and phase: Completed; Phase 3

Conditions: Breast Neoplasms

Treatments: Drug: trastuzumab; Drug: BIBW 2992; Drug: vinorelbine

Study type: Interventional

Funder types: Industry

Identifiers

NCT01125566

2009-015476-98 (EudraCT Number)

1200.75

Details and patient eligibility

About

To investigate the efficacy and safety of BIBW 2992 in combination with vinorelbine i.v. chemotherapy as treatment in patients with HER2-overexpressing, metastatic breast cancer, who failed one prior trastuzumab (Herceptin®) treatment

Enrollment: 508 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Histologically confirmed diagnosis of HER2-overexpression breast cancer
• Stage IV metastatic disease
• Must have progressed on one prior trastuzumab treatment
• no more than one prior trastuzumab based therapy regimen (either adjuvant or first-line)
• Must have received anthracycline and/or taxane based chemotherapy for adjuvant treatment of breast cancer or first-line treatment of metastatic breast cancer
• Must have (archived) tumour tissue sample available for central re-assessment of HER2-status
• At least one measurable lesion according to RECIST 1.1.
• Eastern Cooperative Oncology Group (ECOG) score of 0 or 1 .

Exclusion criteria

• Prior treatment with Epidermal Growth Factor Receptor/Human Epidermal Growth Factor Receptor(EGFR/HER2)-targeted small molecules or antibodies other than trastuzumab
• Prior treatment with vinorelbine
• Known pre-existing interstitial lung disease
• Active brain metastases
• 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 randomisation.
• Cardiac left ventricular function with resting ejection fraction of less than 50%.
• Patients unable to comply with the protocol.
• Any contraindications for therapy with vinorelbine or trastuzumab.
• Known hypersensitivity to BIBW 2992 or the excipients of any of the trial drugs.
• Use of any investigational drug within 4 weeks of randomisation.
• Inadequate hepatic, renal and haematologic organ function

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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508 participants in 2 patient groups

Arm B: trastuzumab with vinorelbine

Active Comparator group

Description:

patients receive weekly intravenous infusion of trastuzumab and vinorelbine

Treatment:

Drug: trastuzumab

Drug: vinorelbine

Drug: vinorelbine

Arm A: BIBW 2992 with vinorelbine

Experimental group

Description:

patients receive BIBW 2992 tablets once daily combined with weekly intravenous infusion of vinorelbine

Treatment:

Drug: vinorelbine

Drug: BIBW 2992

Drug: vinorelbine