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

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by Boehringer Ingelheim
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT01271725
First received: January 6, 2011
Last updated: September 3, 2014
Last verified: September 2014
  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:


Further study details as provided by Boehringer Ingelheim:

Primary Outcome Measures:
  • Objective Response (OR) assessed by RECIST 1.1 (Response Evaluation Criteria in Solid Tumours Version 1.1) [ Time Frame: every 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: 74
Study Start Date: May 2011
Estimated Study Completion Date: January 2015
Estimated Primary Completion Date: January 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:

  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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
Hong Kong
1200.98.85202 Boehringer Ingelheim Investigational Site Active, not recruiting
Hong Kong, Hong Kong
1200.98.85201 Boehringer Ingelheim Investigational Site Completed
Shatin, Hong Kong
India
1200.98.91011 Boehringer Ingelheim Investigational Site Recruiting
Amravati, India
1200.98.91009 Boehringer Ingelheim Investigational Site Recruiting
Maharashtra, India
1200.98.91010 Boehringer Ingelheim Investigational Site Recruiting
Maharashtra, India
1200.98.91004 Boehringer Ingelheim Investigational Site Recruiting
Nagpur, India
1200.98.91001 Boehringer Ingelheim Investigational Site Recruiting
Pune, India
1200.98.91005 Boehringer Ingelheim Investigational Site Recruiting
Thiruvananthapuram, India
Poland
1200.98.48002 Boehringer Ingelheim Investigational Site Terminated
Gdansk, Poland
Russian Federation
1200.98.07014 Boehringer Ingelheim Investigational Site Completed
Kazan, Russian Federation
1200.98.07013 Boehringer Ingelheim Investigational Site Completed
Krasnodar, Russian Federation
1200.98.07004 Boehringer Ingelheim Investigational Site Completed
Moscow, Russian Federation
1200.98.07012 Boehringer Ingelheim Investigational Site Completed
Pyatigorsk, Russian Federation
1200.98.07008 Boehringer Ingelheim Investigational Site Active, not recruiting
Samara, Russian Federation
1200.98.07011 Boehringer Ingelheim Investigational Site Completed
Sochi, Russian Federation
1200.98.07003 Boehringer Ingelheim Investigational Site Completed
Stavropol, Russian Federation
1200.98.07006 Boehringer Ingelheim Investigational Site Terminated
Yaroslavl, Russian Federation
Taiwan
1200.98.88607 Boehringer Ingelheim Investigational Site Active, not recruiting
Taichung, Taiwan
1200.98.88603 Boehringer Ingelheim Investigational Site Active, not recruiting
Taichung, Taiwan
1200.98.88601 Boehringer Ingelheim Investigational Site Active, not recruiting
Taipei, Taiwan
1200.98.88604 Boehringer Ingelheim Investigational Site Active, not recruiting
Taipei, Taiwan
1200.98.88602 Boehringer Ingelheim Investigational Site Active, not recruiting
Taipei, Taiwan
1200.98.88605 Boehringer Ingelheim Investigational Site Active, not recruiting
Taipei, Taiwan
United Kingdom
1200.98.44009 Boehringer Ingelheim Investigational Site Completed
Barnstaple, United Kingdom
1200.98.44001 Boehringer Ingelheim Investigational Site Completed
Bournemouth, United Kingdom
1200.98.44004 Boehringer Ingelheim Investigational Site Completed
Exeter, United Kingdom
1200.98.44005 Boehringer Ingelheim Investigational Site Completed
London, United Kingdom
Sponsors and Collaborators
Boehringer Ingelheim
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
  More Information

No publications provided

Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT01271725     History of Changes
Other Study ID Numbers: 1200.98, 2010-021945-29
Study First Received: January 6, 2011
Last Updated: September 3, 2014
Health Authority: Hong Kong: Department of Health
India: Drugs Controller General of India
Poland: Registration Medicinal Product Medical Device Biocidal Product
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 by Site
Neoplasms
Breast Diseases
Skin Diseases
Paclitaxel
Vinorelbine
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 September 16, 2014