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Trial record 52 of 125 for:    lapatinib | Recruiting, Active, not recruiting, Completed Studies | Phase 2

Lapatinib and Tamoxifen in Treating Patients With Locally Advanced or Metastatic Breast Cancer That Did Not Respond to Previous Tamoxifen

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: NCT00118157
Recruitment Status : Completed
First Posted : July 11, 2005
Results First Posted : December 3, 2014
Last Update Posted : December 4, 2017
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Estrogen Receptor Positive
Male Breast Carcinoma
Progesterone Receptor Positive
Recurrent Breast Carcinoma
Stage IIIB Breast Cancer
Stage IIIC Breast Cancer
Stage IV Breast Cancer
Interventions Other: Laboratory Biomarker Analysis
Drug: Lapatinib Ditosylate
Drug: Tamoxifen Citrate
Enrollment 19
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Arm 1
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Patients receive oral lapatinib and oral tamoxifen once daily on days 1-28.

lapatinib ditosylate: Given orally

tamoxifen citrate: Given orally

Period Title: Overall Study
Started 19
Completed 7
Not Completed 12
Reason Not Completed
Adverse Event             2
Death             8
Withdrawal by Subject             2
Arm/Group Title Arm 1
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Patients receive oral lapatinib and oral tamoxifen once daily on days 1-28.

lapatinib ditosylate: Given orally

tamoxifen citrate: Given orally

Overall Number of Baseline Participants 19
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 19 participants
57
(32 to 84)
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 19 participants
<=18 years
0
   0.0%
Between 18 and 65 years
17
  89.5%
>=65 years
2
  10.5%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 19 participants
Female
19
 100.0%
Male
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 19 participants
19
1.Primary Outcome
Title Tumor Response Rate (Complete and Partial) Assessed by Response Evaluation Criteria in Solid Tumors (RECIST)
Hide Description [Not Specified]
Time Frame 4 weeks
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Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm 1
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Patients receive oral lapatinib and oral tamoxifen once daily on days 1-28.

lapatinib ditosylate: Given orally

tamoxifen citrate: Given orally

Overall Number of Participants Analyzed 17
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: participants
1
(1 to 27)
2.Secondary Outcome
Title Changes in Phosphorylation in Tumor Tissue of Epidermal Growth Factor Receptor (EGFR), HER2, AKT Kinase, MAPK, ER-Ser118, and ER-SER167
Hide Description [Not Specified]
Time Frame Baseline and at 21 days
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Hide Analysis Population Description
Data were not collected due to feasibility.
Arm/Group Title Treatment (Lapatinib, Tamoxifen)
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Patients receive lapatinib ditosylate PO daily and tamoxifen citrate PO daily. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Laboratory Biomarker Analysis: Correlative studies

Lapatinib Ditosylate: Given PO

Tamoxifen Citrate: Given PO

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Arm 1
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Patients receive oral lapatinib and oral tamoxifen once daily on days 1-28.

lapatinib ditosylate: Given orally

tamoxifen citrate: Given orally

All-Cause Mortality
Arm 1
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Arm 1
Affected / at Risk (%) # Events
Total   19/19 (100.00%)    
Blood and lymphatic system disorders   
Hemolysis  1  3/19 (15.79%)  3
Cardiac disorders   
Pericardial effusion  1  1/19 (5.26%)  1
Supraventricular tachycardia  1  1/19 (5.26%)  1
Cardiac disorders - Other, specify  1  4/19 (21.05%)  4
Chest pain - cardiac  1  1/19 (5.26%)  1
Gastrointestinal disorders   
Diarrhea  1  19/19 (100.00%)  19
General disorders   
Death NOS  1  10/19 (52.63%)  10
Fatigue  1  13/19 (68.42%)  13
Investigations   
White blood cell decreased  1  3/19 (15.79%)  3
Metabolism and nutrition disorders   
Dehydration  1  1/19 (5.26%)  1
Hypocalcemia  1  2/19 (10.53%)  2
Musculoskeletal and connective tissue disorders   
Musculoskeletal and connective tissue disorder - Other, specify  1  1/19 (5.26%)  1
Respiratory, thoracic and mediastinal disorders   
Dyspnea  1  5/19 (26.32%)  5
Skin and subcutaneous tissue disorders   
Rash maculo-papular  1  3/19 (15.79%)  3
Vascular disorders   
Thromboembolic event  1  1/19 (5.26%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (V. 3.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Arm 1
Affected / at Risk (%) # Events
Total   17/19 (89.47%)    
Blood and lymphatic system disorders   
Anemia  1  7/19 (36.84%)  7
Eye disorders   
Conjunctivitis  1  1/19 (5.26%)  1
Gastrointestinal disorders   
Nausea  1  7/19 (36.84%)  7
Vomiting  1  4/19 (21.05%)  4
Abdominal pain  1  1/19 (5.26%)  1
Dry mouth  1  2/19 (10.53%)  2
Dyspepsia  1  2/19 (10.53%)  2
General disorders   
Gait disturbance  1  1/19 (5.26%)  1
Non-cardiac chest pain  1  1/19 (5.26%)  1
Pain  1  3/19 (15.79%)  3
Infections and infestations   
Infections and infestations - Other, specify  1  2/19 (10.53%)  2
Investigations   
Weight loss  1  4/19 (21.05%)  4
Alanine aminotransferase increased  1  1/19 (5.26%)  1
Alkaline phosphatase increased  1  1/19 (5.26%)  1
Aspartate aminotransferase increased  1  1/19 (5.26%)  1
Creatinine increased  1  3/19 (15.79%)  3
Neutrophil count decreased  1  1/19 (5.26%)  1
Platelet count decreased  1  2/19 (10.53%)  2
Metabolism and nutrition disorders   
Anorexia  1  6/19 (31.58%)  6
Hyperglycemia  1  3/19 (15.79%)  3
Hypoalbuminemia  1  3/19 (15.79%)  3
Hypophosphatemia  1  2/19 (10.53%)  2
Hypoglycemia  1  2/19 (10.53%)  2
Hypokalemia  1  1/19 (5.26%)  1
Musculoskeletal and connective tissue disorders   
Back pain  1  2/19 (10.53%)  2
Generalized muscle weakness  1  1/19 (5.26%)  1
Pain in extremity  1  4/19 (21.05%)  4
Bone pain  1  1/19 (5.26%)  1
Nervous system disorders   
Dizziness  1  5/19 (26.32%)  5
Headache  1  1/19 (5.26%)  1
Peripheral motor neuropathy  1  1/19 (5.26%)  1
Peripheral sensory neuropathy  1  1/19 (5.26%)  1
Psychiatric disorders   
Anxiety  1  1/19 (5.26%)  1
Depression  1  2/19 (10.53%)  2
Insomnia  1  1/19 (5.26%)  1
Reproductive system and breast disorders   
Vaginal discharge  1  1/19 (5.26%)  1
Vaginal dryness  1  1/19 (5.26%)  1
Vaginal hemorrhage  1  1/19 (5.26%)  1
Respiratory, thoracic and mediastinal disorders   
Cough  1  5/19 (26.32%)  5
Sinus disorder  1  2/19 (10.53%)  2
Skin and subcutaneous tissue disorders   
Hirsutism  1  1/19 (5.26%)  1
Rash acneiform  1  2/19 (10.53%)  2
Dry skin  1  1/19 (5.26%)  1
Hyperhidrosis  1  2/19 (10.53%)  2
Pruritus  1  1/19 (5.26%)  1
Vascular disorders   
Hot flashes  1  1/19 (5.26%)  1
Hypertension  1  1/19 (5.26%)  1
Vascular disorders - Other, specify  1  1/19 (5.26%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (V. 3.0)
The main limitation in this study was poor enrollment. The small number of cases makes the interpretation of results difficult.
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.
Results Point of Contact
Name/Title: Sayeh Lavasani, M.D.
Organization: Barbara Ann Karmanos Cancer Institute
Phone: (313) 576-8751
Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00118157     History of Changes
Other Study ID Numbers: NCI-2009-00080
NCI-2009-00080 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
CDR0000433388
C-2876 ( Other Identifier: Wayne State University/Karmanos Cancer Institute )
6724 ( Other Identifier: CTEP )
P30CA022453 ( U.S. NIH Grant/Contract )
U01CA062487 ( U.S. NIH Grant/Contract )
First Submitted: July 8, 2005
First Posted: July 11, 2005
Results First Submitted: November 21, 2014
Results First Posted: December 3, 2014
Last Update Posted: December 4, 2017