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

Boehringer Ingelheim

Status and phase: Completed; Phase 2

Conditions: Breast Neoplasms

Treatments: Drug: Paclitaxel 80 mg/m2 weekly; Drug: Vinorelbine 25 mg/m2 weekly; Drug: Afatinib 40mg once daily (OD)

Study type: Interventional

Funder types: Industry

Identifiers

NCT01271725

2010-021945-29 (EudraCT Number)

1200.98

Details and patient eligibility

About

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

Enrollment: 74 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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74 participants in 3 patient groups

Afatinib 40mg once daily (OD)

Experimental group

Description:

Patient to receive afatinib monotherapy at a dose of 40 mg/d until progression of their disease

Treatment:

Drug: Afatinib 40mg once daily (OD)

Paclitaxel 80 mg/m2 weekly

Experimental group

Description:

Patients to additionally receive paclitaxel at a dose of 80 mg/m2 weekly on disease progression on afatinib monotherapy

Treatment:

Drug: Paclitaxel 80 mg/m2 weekly

Vinorelbine 25 mg/m2 weekly

Experimental group

Description:

Patients to additionally receive vinorelbine at a dose of 25 mg/m2 weekly on disease progression on afatinib monotherapy

Treatment:

Drug: Vinorelbine 25 mg/m2 weekly