Overview

LUX-Breast 2; Afatinib in HER2 (Human Epidermal Growth Factor Receptor)-Treatment Failures

Status:
Completed
Trial end date:
2017-03-13
Target enrollment:
0
Participant gender:
Female
Summary
The general aim of this study is to investigate the efficacy and safety of afatinib (BIBW 2992) alone and in combination with weekly paclitaxel or weekly vinorelbine (in patients who progress on afatinib monotherapy within this trial) as treatment in patients with HER2-overexpressing, metastatic breast cancer, who failed HER2-targeted treatment in the neoadjuvant or adjuvant setting
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Boehringer Ingelheim
Treatments:
Afatinib
Albumin-Bound Paclitaxel
Paclitaxel
Vinblastine
Vinorelbine
Criteria
Inclusion criteria:

1. Female patients >=18 years with proven diagnosis of HER2-overexpressing,
histologically confirmed breast cancer

2. Stage IV metastatic disease

3. At least one measurable lesion according to RECIST 1.1 (Response Evaluation Criteria
for Solid Tumours version 1.1). Skin, bone and brain lesions are considered non-target
lesions

4. Must have failed or progressed on either trastuzumab or lapatinib or trastuzumab and
lapatinib treatment in the neoadjuvant and/or adjuvant setting

Exclusion criteria:

1. Prior first line therapy for metastatic breast cancer

2. Known pre-existing interstitial lung disease

3. Active brain metastases

4. 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
trial treatment.

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

6. Prior treatment with Epidermal Growth Factor Receptor (EGFR)/HER2-targeted small
molecules or antibodies other than trastuzumab and lapatinib in the neoadjuvant or
adjuvant setting

7. Prior treatment with paclitaxel in the past 12 months

8. Must not have received prior vinorelbine treatment - Further exclusion criteria apply