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

Purpose

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

Condition	Intervention	Phase
Breast Neoplasms	Drug: Vinorelbine 25 mg/m2 weekly Drug: Afatinib 40mg once daily (OD) Drug: Paclitaxel 80 mg/m2 weekly	Phase 2

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
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

Resource links provided by NLM:

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer

Drug Information available for: Paclitaxel Vinorelbine Vinorelbine tartrate

U.S. FDA Resources

Further study details as provided by Boehringer Ingelheim Pharmaceuticals:

Primary Outcome Measures:

Objective Response (OR) assessed by RECIST 1.1 (Response Evaluation Criteria in Solid Tumours Version 1.1) [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Best overall response during each treatment period according to RECIST 1.1 [ Time Frame: Every 6 weeks ] [ Designated as safety issue: No ]
Duration of objective response, defined as the time from first objective response to the time of progression or death. [ Time Frame: Every 6 weeks ] [ Designated as safety issue: No ]
Progression Free Survival [ Time Frame: 12 months ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]

Estimated Enrollment:	120
Study Start Date:	May 2011
Estimated Study Completion Date:	June 2015
Estimated Primary Completion Date:	June 2015 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Afatinib 40mg once daily (OD) Patient to receive afatinib monotherapy at a dose of 40 mg/d until progression of their disease	Drug: Afatinib 40mg once daily (OD) Patient to receive afatinib monotherapy at a dose of 40 mg/d until progression of their disease
Experimental: Paclitaxel 80 mg/m2 weekly Patients to additionally receive paclitaxel at a dose of 80 mg/m2 weekly on disease progression on afatinib monotherapy	Drug: 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: Vinorelbine 25 mg/m2 weekly Patients to additionally receive vinorelbine at a dose of 25 mg/m2 weekly on disease progression on afatinib monotherapy	Drug: Vinorelbine 25 mg/m2 weekly Patients to additionally receive vinorelbine at a dose of 25 mg/m2 weekly on disease progression on afatinib monotherapy

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

Inclusion criteria:

Female patients >=18 years with proven diagnosis of HER2-overexpressing, histologically confirmed breast cancer
Stage IV metastatic disease
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
Must have failed or progressed on either trastuzumab or lapatinib or trastuzumab and lapatinib treatment in the neoadjuvant and/or adjuvant setting

Exclusion criteria:

Prior first line therapy for metastatic breast cancer
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 trial treatment.
Cardiac left ventricular function with resting ejection fraction of less than 50%.
Prior treatment with EGFR/HER2-targeted small molecules or antibodies other than trastuzumab and lapatinib in the neoadjuvant or adjuvant setting
Prior treatment with paclitaxel in the past 12 months
Must not have received prior vinorelbine treatment
Inadequate hepatic, renal and haematologique organ function

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01271725

Contacts

Contact: Boehringer Ingelheim Call Center

1-800-243-0127

clintriage.rdg@boehringer-ingelheim.com

Show 45 Study Locations

Sponsors and Collaborators

Boehringer Ingelheim Pharmaceuticals

Investigators

Study Chair:

Boehringer Ingelheim

Boehringer Ingelheim Pharmaceuticals

More Information

No publications provided

Responsible Party:	Boehringer Ingelheim Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT01271725 History of Changes
Other Study ID Numbers:	1200.98, 2010-021945-29
Study First Received:	January 6, 2011
Last Updated:	May 15, 2013
Health Authority:	Hong Kong: Department of Health India: Drugs Controller General of India Poland: Registration Medicinal Product Medical Device Biocidal Product Romania: National Medicines Agency Russia: Pharmacological Committee, Ministry of Health Taiwan: Department of Health United Kingdom: Medicines and Healthcare Products Regulatory Agency

Additional relevant MeSH terms:

Breast Neoplasms
Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Vinorelbine
Paclitaxel
Antineoplastic Agents, Phytogenic

Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 23, 2013