Overview

This trial is active, not recruiting.

Condition breast neoplasms
Treatments vinorelbine 25 mg/m2 weekly, afatinib 40mg once daily (od), paclitaxel 80 mg/m2 weekly
Phase phase 2
Sponsor Boehringer Ingelheim
Start date May 2011
End date December 2016
Trial size 74 participants
Trial identifier NCT01271725, 1200.98, 2010-021945-29

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Patient to receive afatinib monotherapy at a dose of 40 mg/d until progression of their disease
afatinib 40mg once daily (od)
Patient to receive afatinib monotherapy at a dose of 40 mg/d until progression of their disease
(Experimental)
Patients to additionally receive paclitaxel at a dose of 80 mg/m2 weekly on disease progression on afatinib monotherapy
paclitaxel 80 mg/m2 weekly
Patients to additionally receive paclitaxel at a dose of 80 mg/m2 weekly on disease progression on afatinib monotherapy
(Experimental)
Patients to additionally receive vinorelbine at a dose of 25 mg/m2 weekly on disease progression on afatinib monotherapy
vinorelbine 25 mg/m2 weekly
Patients to additionally receive vinorelbine at a dose of 25 mg/m2 weekly on disease progression on afatinib monotherapy

Primary Outcomes

Measure
Objective Response (OR) assessed by RECIST 1.1 (Response Evaluation Criteria in Solid Tumours Version 1.1)
time frame: every 6 weeks

Secondary Outcomes

Measure
Best overall response during each treatment period according to RECIST 1.1
time frame: Every 6 weeks
Duration of objective response, defined as the time from first objective response to the time of progression or death.
time frame: Every 6 weeks
Progression Free Survival
time frame: 12 months
Safety assessed by the severity and incidence of adverse event according to Common Terminology Criteria for Adverse Events (CTC s, AE Version 3.0), changes in vital signs and safety laboratory parameters
time frame: 12 months

Eligibility Criteria

Female participants at least 18 years old.

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 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 9. Inadequate hepatic, renal and haematologique organ function

Additional Information

Official title LUX-Breast 2; An Open Label, Phase II Trial of Afatinib (BIBW 2992) in Patients With Metastatic HER2-overexpressing Breast Cancer Failing HER2-targeted Treatment in the Neoadjuvant and/or Adjuvant Treatment Setting
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by Boehringer Ingelheim.