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Lapatinib in Women With Metastatic Breast Cancer Who Have Failed Prior Antihormone Therapy

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ClinicalTrials.gov Identifier: NCT00759642
Recruitment Status : Terminated (IRB decision)
First Posted : September 25, 2008
Results First Posted : May 23, 2017
Last Update Posted : July 1, 2019
Sponsor:
Information provided by (Responsible Party):
University of Kansas Medical Center

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Metastatic Breast Cancer
Intervention Drug: lapatinib
Enrollment 33
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Lapatinib
Hide Arm/Group Description

lapatinib + Endocrine therapy (will continue prior antihormone therapy, on which progression was noted)

lapatinib: lapatinib 1500 mg PO daily

Period Title: Overall Study
Started 33
Completed 33
Not Completed 0
Arm/Group Title Lapatinib
Hide Arm/Group Description

lapatinib

lapatinib: lapatinib 1500 mg PO daily

Overall Number of Baseline Participants 33
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 33 participants
<=18 years
0
   0.0%
Between 18 and 65 years
21
  63.6%
>=65 years
12
  36.4%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 33 participants
Female
33
 100.0%
Male
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 33 participants
American Indian or Alaska Native
0
   0.0%
Asian
1
   3.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
1
   3.0%
White
31
  93.9%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 33 participants
33
 100.0%
1.Primary Outcome
Title Progression Free Survival
Hide Description Progression free survival (PFS) will be defined as the interval between the date of study initiation and the earliest date of disease progression, determined by tumor assessment.
Time Frame 12 months
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Hide Analysis Population Description
[Not Specified]
Arm/Group Title Lapatinib
Hide Arm/Group Description:

lapatinib + Endocrine therapy

lapatinib: lapatinib 1500 mg PO daily

Overall Number of Participants Analyzed 33
Median (80% Confidence Interval)
Unit of Measure: months
2.1
(1 to 12)
Time Frame 5 years (2009-2014)
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Lapatinib
Hide Arm/Group Description

lapatinib + Endocrine therapy (will continue prior antihormone therapy, on which progression was noted)

lapatinib: lapatinib 1500 mg PO daily

All-Cause Mortality
Lapatinib
Affected / at Risk (%)
Total   0/33 (0.00%) 
Hide Serious Adverse Events
Lapatinib
Affected / at Risk (%)
Total   6/33 (18.18%) 
Eye disorders   
Blurred vision * 1  1/33 (3.03%) 
Gastrointestinal disorders   
Anorexia * 1  1/33 (3.03%) 
Diarrhea * 1  1/33 (3.03%) 
Nausea * 1  1/33 (3.03%) 
Vomiting * 1  1/33 (3.03%) 
General disorders   
Neck pain * 1  1/33 (3.03%) 
Hepatobiliary disorders   
Pancreatitis * 1  1/33 (3.03%) 
Infections and infestations   
Skin infection * 1  1/33 (3.03%) 
Musculoskeletal and connective tissue disorders   
Gait abnormal * 1  1/33 (3.03%) 
1
Term from vocabulary, CTCAE (3.0)
*
Indicates events were collected by non-systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Lapatinib
Affected / at Risk (%)
Total   33/33 (100.00%) 
Blood and lymphatic system disorders   
Leukocytes * 1  1/33 (3.03%) 
Neutrophils low * 1  2/33 (6.06%) 
Cardiac disorders   
Left ventricular diastolic dysfunction * 1  1/33 (3.03%) 
Palpitations * 1  1/33 (3.03%) 
Vasovagal episode * 1  1/33 (3.03%) 
Ear and labyrinth disorders   
Auditory/Ear - Other (Specify) * 1 [1]  1/33 (3.03%) 
Hearing (without monitoring program) * 1  1/33 (3.03%) 
Endocrine disorders   
Hot flashes * 1  3/33 (9.09%) 
Eye disorders   
Blurred vision * 1  1/33 (3.03%) 
Diplopia * 1  1/33 (3.03%) 
Ocular - Other (Specify) * 1 [2]  1/33 (3.03%) 
Gastrointestinal disorders   
Ascites * 1  1/33 (3.03%) 
Constipation * 1  3/33 (9.09%) 
Dehydration * 1  5/33 (15.15%) 
Diarrhea * 1  25/33 (75.76%) 
Dry mouth * 1  3/33 (9.09%) 
Ear, nose and throat examination abnormal * 1 [3]  2/33 (6.06%) 
Fecal incontinence * 1  1/33 (3.03%) 
Heartburn * 1  1/33 (3.03%) 
Mucositis oral * 1  1/33 (3.03%) 
Nausea * 1  13/33 (39.39%) 
Oral pain * 1  2/33 (6.06%) 
Vomiting * 1  7/33 (21.21%) 
General disorders   
Abdominal pain * 1  2/33 (6.06%) 
Edema limbs * 1  2/33 (6.06%) 
Facial pain * 1  1/33 (3.03%) 
Fatigue * 1  10/33 (30.30%) 
Fever * 1  2/33 (6.06%) 
Flu-like syndrome * 1  2/33 (6.06%) 
Headache * 1  6/33 (18.18%) 
Pain in extremity * 1  4/33 (12.12%) 
Rigors/chills * 1  1/33 (3.03%) 
Infections and infestations   
Bronchitis * 1  1/33 (3.03%) 
Colitis, infectious (e.g., Clostridium difficile) * 1  1/33 (3.03%) 
Gastric infection * 1  1/33 (3.03%) 
Infection, Upper airway NOS * 1  1/33 (3.03%) 
Mucosal infection * 1  1/33 (3.03%) 
Upper respiratory infection * 1  1/33 (3.03%) 
Urinary tract infection * 1  1/33 (3.03%) 
Injury, poisoning and procedural complications   
Fracture * 1  1/33 (3.03%) 
Investigations   
Weight loss * 1  3/33 (9.09%) 
Metabolism and nutrition disorders   
Alanine aminotransferase increased * 1  1/33 (3.03%) 
Alkaline phosphatase increased * 1  1/33 (3.03%) 
Aspartate aminotransferase increased * 1  1/33 (3.03%) 
Creatinine increased * 1  1/33 (3.03%) 
Hypocalcemia * 1  2/33 (6.06%) 
Hypokalemia * 1  3/33 (9.09%) 
Musculoskeletal and connective tissue disorders   
Back pain * 1  3/33 (9.09%) 
Bone pain * 1  1/33 (3.03%) 
Joint pain * 1  1/33 (3.03%) 
Muscle weakness * 1  2/33 (6.06%) 
Myalgia * 1  1/33 (3.03%) 
Neck pain * 1  1/33 (3.03%) 
Nervous system disorders   
Abducens nerve disorder * 1  1/33 (3.03%) 
Acoustic nerve disorder NOS * 1  1/33 (3.03%) 
Anxiety * 1  1/33 (3.03%) 
Dizziness * 1  4/33 (12.12%) 
Neurology - Other (Specify) * 1 [4]  1/33 (3.03%) 
Peripheral sensory neuropathy * 1  1/33 (3.03%) 
Tremor * 1  1/33 (3.03%) 
Psychiatric disorders   
Anorexia * 1  7/33 (21.21%) 
Confusion * 1  1/33 (3.03%) 
Depression * 1  1/33 (3.03%) 
Insomnia * 1  4/33 (12.12%) 
Memory impairment * 1  1/33 (3.03%) 
Renal and urinary disorders   
Urinary incontinence * 1  1/33 (3.03%) 
Reproductive system and breast disorders   
Breast pain * 1  1/33 (3.03%) 
Perineal pain * 1  1/33 (3.03%) 
Vaginal dryness * 1  1/33 (3.03%) 
Respiratory, thoracic and mediastinal disorders   
Atelectasis * 1  1/33 (3.03%) 
Chest wall pain * 1  1/33 (3.03%) 
Cough * 1  4/33 (12.12%) 
Dyspnea * 1  4/33 (12.12%) 
Hemorrhage nasal * 1  1/33 (3.03%) 
Nasal/paranasal reactions * 1  1/33 (3.03%) 
Pharyngolaryngeal pain * 1  2/33 (6.06%) 
Pleural effusion * 1  1/33 (3.03%) 
Rhinitis * 1  1/33 (3.03%) 
Skin and subcutaneous tissue disorders   
Acne * 1  9/33 (27.27%) 
Dermatology/Skin - Other (Specify) * 1 [5]  1/33 (3.03%) 
Dermatology/Skin - Other (Specify) * 1 [6]  1/33 (3.03%) 
Dry skin * 1  3/33 (9.09%) 
Erythema multiforme * 1  1/33 (3.03%) 
Hand-and-foot syndrome * 1  3/33 (9.09%) 
Pain of skin * 1  1/33 (3.03%) 
Pruritus * 1  4/33 (12.12%) 
Rash * 1  12/33 (36.36%) 
Sweating * 1  1/33 (3.03%) 
Urticaria * 1  1/33 (3.03%) 
1
Term from vocabulary, CTCAE (3.0)
*
Indicates events were collected by non-systematic assessment
[1]
fullness in the right ear without pain
[2]
left eye ptosis
[3]
mouth sores/ulcerations
[4]
feet feel hot but no fever
[5]
scratches on back
[6]
irritation at breast folds
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Priyanka Sharma, MD
Organization: University of Kansas Cancer Center
Phone: 913-945-5059
EMail: PSHARMA2@kumc.edu
Layout table for additonal information
Responsible Party: University of Kansas Medical Center
ClinicalTrials.gov Identifier: NCT00759642    
Other Study ID Numbers: 11495
First Submitted: September 24, 2008
First Posted: September 25, 2008
Results First Submitted: April 17, 2017
Results First Posted: May 23, 2017
Last Update Posted: July 1, 2019