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Trial record 64 of 125 for:    lapatinib | Recruiting, Active, not recruiting, Completed Studies | Phase 2

6 Weeks Treatment of Locally Advanced Breast Cancer With BIBW 2992 (Afatinib) or Lapatinib or Trastuzumab

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00826267
Recruitment Status : Completed
First Posted : January 22, 2009
Results First Posted : October 17, 2013
Last Update Posted : December 31, 2013
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Breast Neoplasms
Interventions Drug: lapatinib
Drug: BIBW 2992
Drug: trastuzumab
Enrollment 29
Recruitment Details Because of slow enrollment and a high screen-failure rate, recruitment became a challenge and the sponsor chose to terminate the trial prior to reaching the target enrollment of 120 patients.
Pre-assignment Details  
Arm/Group Title Afatinib 50 mg Lapatinib 1500 mg Trastuzumab
Hide Arm/Group Description Patients received continuous daily dosing with Afatinib 50 mg orally from Day 1 to Day 21 of each treatment course. 2 treatment courses were to be given in the trial. Patients received continuous daily dosing with Lapatinib 1500 mg orally from Day 1 to Day 21 of each treatment course. 2 treatment courses were to be given in the trial. Patients received weekly trastuzumab infusions of 2 mg/kg following a loading dose of 4 mg/kg per SPC. 6 infusions were to be given over 2 treatment courses.
Period Title: Overall Study
Started 10 8 11
Completed 9 8 11
Not Completed 1 0 0
Reason Not Completed
Other Adverse Event             1             0             0
Arm/Group Title Afatinib 50 mg Lapatinib 1500 mg Trastuzumab Total
Hide Arm/Group Description Patients received continuous daily dosing with Afatinib 50 mg orally from Day 1 to Day 21 of each treatment course. 2 treatment courses were to be given in the trial. Patients received continuous daily dosing with Lapatinib 1500 mg orally from Day 1 to Day 21 of each treatment course. 2 treatment courses were to be given in the trial. Patients received weekly trastuzumab infusions of 2 mg/kg following a loading dose of 4 mg/kg per SPC. 6 infusions were to be given over 2 treatment courses. Total of all reporting groups
Overall Number of Baseline Participants 10 8 11 29
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 10 participants 8 participants 11 participants 29 participants
50.7  (8.7) 58.5  (13.4) 44.1  (12.2) 50.3  (12.5)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants 8 participants 11 participants 29 participants
Female
10
 100.0%
8
 100.0%
11
 100.0%
29
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1.Primary Outcome
Title Objective Response (OR)
Hide Description Objective response (complete or partial) was assessed according to RECIST 1.0 criteria.
Time Frame Tumour assessments were performed at screening, day 22 and day 43.
Hide Outcome Measure Data
Hide Analysis Population Description
Treated set (TS). TS consisted of all patients who received at least one dose of study medication.
Arm/Group Title Afatinib 50 mg Lapatinib 1500 mg Trastuzumab
Hide Arm/Group Description:
Patients received continuous daily dosing with Afatinib 50 mg orally from Day 1 to Day 21 of each treatment course. 2 treatment courses were to be given in the trial.
Patients received continuous daily dosing with Lapatinib 1500 mg orally from Day 1 to Day 21 of each treatment course. 2 treatment courses were to be given in the trial.
Patients received weekly trastuzumab infusions of 2 mg/kg following a loading dose of 4 mg/kg per SPC. 6 infusions were to be given over 2 treatment courses.
Overall Number of Participants Analyzed 10 8 11
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
80.0
(44.4 to 97.5)
75.0
(34.9 to 96.8)
36.4
(10.9 to 69.2)
2.Secondary Outcome
Title Number of Participants Who Achieved Clinical Benefit (CB)
Hide Description CB was defined as CR, PR or stable disease (SD) and was assessed according to RECIST criteria regardless of treatment status.
Time Frame Tumour assessments were performed at screening, day 22 and day 43.
Hide Outcome Measure Data
Hide Analysis Population Description
TS
Arm/Group Title Afatinib 50 mg Lapatinib 1500 mg Trastuzumab
Hide Arm/Group Description:
Patients received continuous daily dosing with Afatinib 50 mg orally from Day 1 to Day 21 of each treatment course. 2 treatment courses were to be given in the trial.
Patients received continuous daily dosing with Lapatinib 1500 mg orally from Day 1 to Day 21 of each treatment course. 2 treatment courses were to be given in the trial.
Patients received weekly trastuzumab infusions of 2 mg/kg following a loading dose of 4 mg/kg per SPC. 6 infusions were to be given over 2 treatment courses.
Overall Number of Participants Analyzed 10 8 11
Measure Type: Number
Unit of Measure: Participants
10 8 11
3.Secondary Outcome
Title Change From Baseline in the Diameter of the Primary Target Lesion.
Hide Description Change was based on the primary lesion only rather that the sum of the target lesions as most patients had only one lesion.
Time Frame 3 weeks or 6 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
TS
Arm/Group Title Afatinib 50 mg Lapatinib 1500 mg Trastuzumab
Hide Arm/Group Description:
Patients received continuous daily dosing with Afatinib 50 mg orally from Day 1 to Day 21 of each treatment course. 2 treatment courses were to be given in the trial.
Patients received continuous daily dosing with Lapatinib 1500 mg orally from Day 1 to Day 21 of each treatment course. 2 treatment courses were to be given in the trial.
Patients received weekly trastuzumab infusions of 2 mg/kg following a loading dose of 4 mg/kg per SPC. 6 infusions were to be given over 2 treatment courses.
Overall Number of Participants Analyzed 10 8 11
Least Squares Mean (Standard Error)
Unit of Measure: millimeters
-27.5  (5.90) -31.0  (6.63) -20.9  (5.63)
4.Secondary Outcome
Title Plasma Concentration of Afatinib
Hide Description Individual drug plasma concentrations of afatinib after multiple oral administrations at day 7
Time Frame Day 7
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Afatinib 50mg
Hide Arm/Group Description:
Patients received Afatinib 50 mg at day 7.
Overall Number of Participants Analyzed 10
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: ng/mL
32.1
(43.0%)
5.Secondary Outcome
Title Changes in Biomarker in Tumour Biopsies
Hide Description Changes in the biomarkers (Phospho-MAP-Kinase (MAPK), Total MAPK expression, EGFR, HER2, Phospho-EGFR and -HER2, Proliferation marker (Ki67 and p27), Apoptotic index (cleaved caspase 3), Phosphate and tensin homolog (PTEN), HER2 homodimerisation by HERmark assay and Phospho AKT) from biopsy tissue.
Time Frame Screening, day 22, day 43
Hide Outcome Measure Data
Hide Analysis Population Description
TS. The small number of available biomarker samples in this study did not allow for a meaningful statistical analysis.
Arm/Group Title Afatinib 50 mg Lapatinib 1500 mg Trastuzumab
Hide Arm/Group Description:
Patients received continuous daily dosing with Afatinib 50 mg orally from Day 1 to Day 21 of each treatment course. 2 treatment courses were to be given in the trial.
Patients received continuous daily dosing with Lapatinib 1500 mg orally from Day 1 to Day 21 of each treatment course. 2 treatment courses were to be given in the trial.
Patients received weekly trastuzumab infusions of 2 mg/kg following a loading dose of 4 mg/kg per SPC. 6 infusions were to be given over 2 treatment courses.
Overall Number of Participants Analyzed 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame Up to 28 days following the end-of-treatment visit.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Afatinib 50 mg Lapatinib 1500 mg Trastuzumab
Hide Arm/Group Description Patients received continuous daily dosing with Afatinib 50 mg orally from Day 1 to Day 21 of each treatment course. 2 treatment courses were to be given in the trial. Patients received continuous daily dosing with Lapatinib 1500 mg orally from Day 1 to Day 21 of each treatment course. 2 treatment courses were to be given in the trial. Patients received weekly trastuzumab infusions of 2 mg/kg following a loading dose of 4 mg/kg per SPC. 6 infusions were to be given over 2 treatment courses.
All-Cause Mortality
Afatinib 50 mg Lapatinib 1500 mg Trastuzumab
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Afatinib 50 mg Lapatinib 1500 mg Trastuzumab
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/10 (0.00%)   0/8 (0.00%)   0/11 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Afatinib 50 mg Lapatinib 1500 mg Trastuzumab
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   10/10 (100.00%)   8/8 (100.00%)   8/11 (72.73%) 
Blood and lymphatic system disorders       
Leukopenia  1  0/10 (0.00%)  1/8 (12.50%)  0/11 (0.00%) 
Lymphatic disorder  1  0/10 (0.00%)  0/8 (0.00%)  1/11 (9.09%) 
Neutropenia  1  0/10 (0.00%)  2/8 (25.00%)  0/11 (0.00%) 
Cardiac disorders       
Cyanosis  1  0/10 (0.00%)  0/8 (0.00%)  1/11 (9.09%) 
Palpitations  1  0/10 (0.00%)  0/8 (0.00%)  1/11 (9.09%) 
Ear and labyrinth disorders       
Ear discomfort  1  0/10 (0.00%)  0/8 (0.00%)  1/11 (9.09%) 
Eye disorders       
Vision blurred  1  0/10 (0.00%)  0/8 (0.00%)  1/11 (9.09%) 
Visual acuity reduced  1  0/10 (0.00%)  0/8 (0.00%)  1/11 (9.09%) 
Gastrointestinal disorders       
Abdominal distension  1  0/10 (0.00%)  1/8 (12.50%)  0/11 (0.00%) 
Abdominal pain  1  1/10 (10.00%)  1/8 (12.50%)  1/11 (9.09%) 
Abdominal pain upper  1  0/10 (0.00%)  0/8 (0.00%)  1/11 (9.09%) 
Constipation  1  0/10 (0.00%)  0/8 (0.00%)  2/11 (18.18%) 
Diarrhoea  1  10/10 (100.00%)  3/8 (37.50%)  1/11 (9.09%) 
Dyspepsia  1  0/10 (0.00%)  2/8 (25.00%)  1/11 (9.09%) 
Haemorrhoids  1  0/10 (0.00%)  0/8 (0.00%)  1/11 (9.09%) 
Lip dry  1  1/10 (10.00%)  0/8 (0.00%)  0/11 (0.00%) 
Nausea  1  1/10 (10.00%)  2/8 (25.00%)  3/11 (27.27%) 
Oral discomfort  1  1/10 (10.00%)  0/8 (0.00%)  1/11 (9.09%) 
Oral pain  1  0/10 (0.00%)  0/8 (0.00%)  1/11 (9.09%) 
Stomatitis  1  0/10 (0.00%)  1/8 (12.50%)  0/11 (0.00%) 
Vomiting  1  1/10 (10.00%)  0/8 (0.00%)  2/11 (18.18%) 
General disorders       
Asthenia  1  0/10 (0.00%)  1/8 (12.50%)  0/11 (0.00%) 
Chills  1  0/10 (0.00%)  0/8 (0.00%)  2/11 (18.18%) 
Fatigue  1  0/10 (0.00%)  1/8 (12.50%)  0/11 (0.00%) 
Influenza like illness  1  0/10 (0.00%)  1/8 (12.50%)  0/11 (0.00%) 
Mucosal inflammation  1  4/10 (40.00%)  0/8 (0.00%)  1/11 (9.09%) 
Pain  1  0/10 (0.00%)  0/8 (0.00%)  1/11 (9.09%) 
Pyrexia  1  1/10 (10.00%)  1/8 (12.50%)  0/11 (0.00%) 
Infections and infestations       
Ear infection  1  1/10 (10.00%)  0/8 (0.00%)  0/11 (0.00%) 
Fungal infection  1  1/10 (10.00%)  0/8 (0.00%)  0/11 (0.00%) 
Nasopharyngitis  1  1/10 (10.00%)  0/8 (0.00%)  0/11 (0.00%) 
Oral candidiasis  1  1/10 (10.00%)  0/8 (0.00%)  0/11 (0.00%) 
Paronychia  1  5/10 (50.00%)  0/8 (0.00%)  0/11 (0.00%) 
Rash pustular  1  1/10 (10.00%)  0/8 (0.00%)  0/11 (0.00%) 
Respiratory tract infection  1  1/10 (10.00%)  0/8 (0.00%)  0/11 (0.00%) 
Skin infection  1  1/10 (10.00%)  0/8 (0.00%)  0/11 (0.00%) 
Urinary tract infection  1  1/10 (10.00%)  0/8 (0.00%)  0/11 (0.00%) 
Viral sinusitis  1  1/10 (10.00%)  0/8 (0.00%)  0/11 (0.00%) 
Investigations       
Activated partial thromboplastin time prolonged  1  1/10 (10.00%)  0/8 (0.00%)  0/11 (0.00%) 
Aspartate aminotransferase increased  1  1/10 (10.00%)  0/8 (0.00%)  0/11 (0.00%) 
Blood creatine phosphokinase increased  1  1/10 (10.00%)  0/8 (0.00%)  0/11 (0.00%) 
Weight decreased  1  0/10 (0.00%)  1/8 (12.50%)  0/11 (0.00%) 
Metabolism and nutrition disorders       
Hypocalcaemia  1  2/10 (20.00%)  0/8 (0.00%)  0/11 (0.00%) 
Musculoskeletal and connective tissue disorders       
Arthralgia  1  0/10 (0.00%)  0/8 (0.00%)  4/11 (36.36%) 
Musculoskeletal pain  1  0/10 (0.00%)  0/8 (0.00%)  1/11 (9.09%) 
Myalgia  1  0/10 (0.00%)  0/8 (0.00%)  2/11 (18.18%) 
Neck pain  1  0/10 (0.00%)  0/8 (0.00%)  2/11 (18.18%) 
Pain in extremity  1  0/10 (0.00%)  0/8 (0.00%)  1/11 (9.09%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Tumour pain  1  0/10 (0.00%)  1/8 (12.50%)  0/11 (0.00%) 
Nervous system disorders       
Headache  1  2/10 (20.00%)  1/8 (12.50%)  4/11 (36.36%) 
Tremor  1  0/10 (0.00%)  0/8 (0.00%)  1/11 (9.09%) 
Renal and urinary disorders       
Dysuria  1  1/10 (10.00%)  0/8 (0.00%)  0/11 (0.00%) 
Haematuria  1  1/10 (10.00%)  0/8 (0.00%)  0/11 (0.00%) 
Urinary retention  1  1/10 (10.00%)  0/8 (0.00%)  0/11 (0.00%) 
Urinary tract disorder  1  0/10 (0.00%)  1/8 (12.50%)  0/11 (0.00%) 
Reproductive system and breast disorders       
Breast mass  1  0/10 (0.00%)  0/8 (0.00%)  1/11 (9.09%) 
Breast pain  1  0/10 (0.00%)  1/8 (12.50%)  1/11 (9.09%) 
Dysmenorrhoea  1  0/10 (0.00%)  1/8 (12.50%)  0/11 (0.00%) 
Vulvovaginal pruritus  1  1/10 (10.00%)  0/8 (0.00%)  0/11 (0.00%) 
Respiratory, thoracic and mediastinal disorders       
Nasal dryness  1  1/10 (10.00%)  0/8 (0.00%)  0/11 (0.00%) 
Oropharyngeal pain  1  0/10 (0.00%)  0/8 (0.00%)  1/11 (9.09%) 
Rhinorrhoea  1  0/10 (0.00%)  0/8 (0.00%)  1/11 (9.09%) 
Skin and subcutaneous tissue disorders       
Dermatitis  1  0/10 (0.00%)  0/8 (0.00%)  1/11 (9.09%) 
Dermatitis acneiform  1  6/10 (60.00%)  0/8 (0.00%)  0/11 (0.00%) 
Erythema  1  1/10 (10.00%)  0/8 (0.00%)  1/11 (9.09%) 
Excessive granulation tissue  1  1/10 (10.00%)  0/8 (0.00%)  0/11 (0.00%) 
Pruritus  1  1/10 (10.00%)  0/8 (0.00%)  0/11 (0.00%) 
Rash  1  3/10 (30.00%)  1/8 (12.50%)  0/11 (0.00%) 
Rash erythematous  1  1/10 (10.00%)  0/8 (0.00%)  0/11 (0.00%) 
Rash follicular  1  1/10 (10.00%)  0/8 (0.00%)  0/11 (0.00%) 
Skin ulcer  1  1/10 (10.00%)  0/8 (0.00%)  0/11 (0.00%) 
Urticaria  1  0/10 (0.00%)  0/8 (0.00%)  1/11 (9.09%) 
Vascular disorders       
Hypertension  1  0/10 (0.00%)  0/8 (0.00%)  1/11 (9.09%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 14.0
Because of slow enrollment and a high screen-failure rate, recruitment became a challenge and the sponsor chose to terminate the trial prior to reaching the target enrollment of 120 pat. Small number of subjects lead to some shortcomings in analyses.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Any publication of the result of this trial must be consistent with the Boehringer Ingelheim publication policy. The rights of the investigator and of the sponsor with regard to publication of the results of this trial are described in the investigator contract.
Results Point of Contact
Name/Title: Boehringer Ingelheim Call Center
Organization: Boehringer Ingelheim Pharmaceuticals
Phone: 1-800-243-0127
Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT00826267     History of Changes
Other Study ID Numbers: 1200.44
First Submitted: January 20, 2009
First Posted: January 22, 2009
Results First Submitted: August 8, 2013
Results First Posted: October 17, 2013
Last Update Posted: December 31, 2013