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

• Status: Completed
• Trial end date: 2018-07-06
• Target enrollment: 0
• Participant gender: Female

Summary

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Boehringer Ingelheim
• Treatments: Afatinib; Trastuzumab; Vinblastine; Vinorelbine

Criteria

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