LUX-Breast 1: BIBW 2992 (Afatinib) in HER2-positive Metastatic Breast Cancer Patients After One Prior Herceptin Treatment
- Conditions
- Breast Neoplasms
- Interventions
- Registration Number
- NCT01125566
- Lead Sponsor
- Boehringer Ingelheim
- Brief Summary
To investigate the efficacy and safety of BIBW 2992 in combination with vinorelbine i.v. chemotherapy as treatment in patients with HER2-overexpressing, metastatic breast cancer, who failed one prior trastuzumab (Herceptin®) treatment
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 508
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Arm A: BIBW 2992 with vinorelbine BIBW 2992 patients receive BIBW 2992 tablets once daily combined with weekly intravenous infusion of vinorelbine Arm B: trastuzumab with vinorelbine vinorelbine patients receive weekly intravenous infusion of trastuzumab and vinorelbine Arm B: trastuzumab with vinorelbine trastuzumab patients receive weekly intravenous infusion of trastuzumab and vinorelbine Arm A: BIBW 2992 with vinorelbine vinorelbine patients receive BIBW 2992 tablets once daily combined with weekly intravenous infusion of vinorelbine
- Primary Outcome Measures
Name Time Method Progression-free Survival (PFS) From randomization (07Sep2010) until disease progression, death or data cut-off (08Jun2013); Up to 34 months PFS is defined as time from randomisation to disease progression or death whichever occurs first. Assessed by investigator according to the Response Evaluation Criteria in Solid Tumours (RECIST 1.1). RECIST is a set of published rules that define when tumors in cancer patients improve ("respond"), stay the same ("stabilize") or worsen ("progress") during treatment.
Only data collected until the cut-off date for RECIST 1.1 based endpoints (08Jun2013) were considered.
Progression of disease was determined if at least 1 of the following criteria applied:
* At least a 20% increase in the sum of the diameters (SoD) of target lesions taking as reference the smallest SoD recorded since the treatment started, together with an absolute increase in the SoD of at least 5 mm
* Appearance of 1 or more new lesions
* Unequivocal progression of existing non-target lesions
- Secondary Outcome Measures
Name Time Method Overall Survival (OS) From randomisation (07Sep2010) to database lock (30Jul2018), up to 95 months. OS is defined as time from randomisation to death irrespective of the cause of the death.
For patients who had not died up to the cut-off date (03Sep2013), the date they were last known to be alive was derived from the patient status records, the trial completion record, radiological imaging assessments, the study treatment termination record, and the randomisation date.Best RECIST Assessment From randomization (07Sep2010) until disease progression, death or data cut-off (08Jun2013); Up to 34 months Best RECIST assessment is defined as CR, PR, stable disease (SD), progressive disease (PD) or not evaluable by investigator (RECIST version 1.1).
CR for target lesions (TL): Disappearance of all target lesions.
CR for non-target lesions (NTL): Disappearance of all non-target lesions and normalization of tumour marker level. All lymph nodes must be non-pathological in size (\<10mm short axis).
PR: At least a 30% decrease in the sum of diameters (SoD) of target lesions taking as reference the baseline sum diameters.
SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as references the smallest SoD while on study.
PD: At least a 20% increase in the SoD of target lesions, taking as references the smallest sum on study (this includes the baseline sum if that is the smallest on study). Also, the sum must also demonstrate an absolute increase of a least 5mm. Appearance of one or more new lesions.Objective Response (OR) Post baseline tumour-imaging was performed at Week 8, 16, 24, 32, 40, 48, 56 and then every 12 weeks (Until final data-base lock on 30 Jul 2018; Up to 95 months) OR is defined as complete response (CR) and partial response (PR). Assessed by investigator according to Response Evaluation Criteria in Solid Tumours (RECIST) 1.1. Complete Response (CR) for target lesions (TL): Disappearance of all target lesions.
Complete Response (CR) for non-target lesions (NTL): Disappearance of all non-target lesions and normalization of tumour marker level. All lymph nodes must be non-pathological in size (\<10mm short axis)
Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions taking as reference the baseline sum diameters.
Other factors which add to the overall response of an imaging timepoint as PR are as below:-
* CR in TL, but non-CR/Non-PD in NTL leads to PR
* CR in TL, but not evaluated NTL leads to PR
* PR in TL, but non-PD NTL or not all evaluated NTL leads to PR
Trial Locations
- Locations (206)
Achieve Clinical Research, LLC
🇺🇸Birmingham, Alabama, United States
Ironwood Cancer and Research Centers
🇺🇸Chandler, Arizona, United States
Robert A. Moss MD, FACP, Inc
🇺🇸Fountain Valley, California, United States
St. Jude Heritage Healthcare
🇺🇸Fullerton, California, United States
University of California
🇺🇸Los Angeles, California, United States
Cancer Care Associates Medical Group, Inc
🇺🇸Redondo Beach, California, United States
Santa Barbara Hematology Oncology Medical Group, Inc
🇺🇸Santa Barbara, California, United States
Central Coast Medical Oncology Corporation
🇺🇸Santa Maria, California, United States
North Shore Cancer Research Associates
🇺🇸Skokie, Illinois, United States
Cedar Valley Cancer Center
🇺🇸Waterloo, Iowa, United States
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