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Paclitaxel With Trastuzumab and Lapatinib in HER2-Positive Early Stage Breast Cancer

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ClinicalTrials.gov Identifier: NCT01827163
Recruitment Status : Completed
First Posted : April 9, 2013
Results First Posted : December 18, 2019
Last Update Posted : December 18, 2019
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition HER2-Positive Early Stage Breast Cancer
Interventions Drug: Paclitaxel
Drug: Trastuzumab
Drug: Lapatinib
Drug: Pegfilgrastim
Enrollment 20
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Paclitaxel With Trastuzumab and Lapatinib
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Paclitaxel (T) at 175 mg/m2 q 2 weeks x 4 with filgrastim/pegfilgrastim + trastuzumab (H) + daily oral lapatinib (L), followed by trastuzumab q 3 weeks x 15 doses + daily oral lapatinib (HL). Pegfilgrastim 6mg will be given subcutaneously (SQ) on day # 2 of each paclitaxel administration. Filgrastim may be used in lieu of pegfilgrastim at physician's discretion. Trastuzumab will be administered weekly (4 mg/kg bolus followed by 2 mg/kg weekly) starting with paclitaxel treatment cycle # 1. After 4 cycles of paclitaxel, pts will receive trastuzumab on a q 3 weeks x 15 doses (to complete about one year). The q 3 week trastuzumab may be started from 1-3 weeks after the last dose of paclitaxel. A total of 15 infusions of trastuzumab will be given q 3 weeks after the completion of paclitaxel during the HL phase. Lapatinib will be given orally at 1000 mg daily, starting with paclitaxel during the THL phase & continued for the remaining year during the HL phase for about a year.

Paclitaxel

Period Title: Overall Study
Started 20
Completed 9
Not Completed 11
Reason Not Completed
Hypersensitivity reaction to Paclitaxel             2
Adverse Event             9
Arm/Group Title Paclitaxel With Trastuzumab and Lapatinib
Hide Arm/Group Description

Paclitaxel (T) at 175 mg/m2 q 2 weeks x 4 with filgrastim/pegfilgrastim + trastuzumab (H) + daily oral lapatinib (L), followed by trastuzumab q 3 weeks x 15 doses + daily oral lapatinib (HL). Pegfilgrastim 6mg will be given subcutaneously (SQ) on day # 2 of each paclitaxel administration. Filgrastim may be used in lieu of pegfilgrastim at physician's discretion. Trastuzumab will be administered weekly (4 mg/kg bolus followed by 2 mg/kg weekly) starting with paclitaxel treatment cycle # 1. After 4 cycles of paclitaxel, pts will receive trastuzumab on a q 3 weeks x 15 doses (to complete about one year). The q 3 week trastuzumab may be started from 1-3 weeks after the last dose of paclitaxel. A total of 15 infusions of trastuzumab will be given q 3 weeks after the completion of paclitaxel during the HL phase. Lapatinib will be given orally at 1000 mg daily, starting with paclitaxel during the THL phase & continued for the remaining year during the HL phase for about a year.

Paclitaxel

Overall Number of Baseline Participants 20
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 20 participants
49
(33 to 74)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants
Female
20
 100.0%
Male
0
   0.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants
Hispanic or Latino
3
  15.0%
Not Hispanic or Latino
17
  85.0%
Unknown or Not Reported
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants
American Indian or Alaska Native
0
   0.0%
Asian
1
   5.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
2
  10.0%
White
16
  80.0%
More than one race
0
   0.0%
Unknown or Not Reported
1
   5.0%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 20 participants
20
 100.0%
1.Primary Outcome
Title Number of Participants Who Are Able to Complete THL (Paclitaxel, Trastuzumab, and Lapatinib) Without a Dose Delay or Reduction, Grade 3 or Greater QTc Prolongation
Hide Description The primary objective of this trial is to determine the feasibility of this regimen in patients with node-negative HER-2/neu overexpressed /amplified breast cancer with a tumor size of < 3 cm. The regimen is considered feasible if patients are able to complete the paclitaxel, trastuzumab, and lapatinib (THL) portion of the regimen without a dose delay or reduction or grade 3 or greater QTc prolongation.
Time Frame 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Paclitaxel With Trastuzumab and Lapatinib
Hide Arm/Group Description:

Paclitaxel (T) at 175 mg/m2 q 2 weeks x 4 with filgrastim/pegfilgrastim + trastuzumab (H) + daily oral lapatinib (L), followed by trastuzumab q 3 weeks x 15 doses + daily oral lapatinib (HL). Pegfilgrastim 6mg will be given subcutaneously (SQ) on day # 2 of each paclitaxel administration. Filgrastim may be used in lieu of pegfilgrastim at physician's discretion. Trastuzumab will be administered weekly (4 mg/kg bolus followed by 2 mg/kg weekly) starting with paclitaxel treatment cycle # 1. After 4 cycles of paclitaxel, pts will receive trastuzumab on a q 3 weeks x 15 doses (to complete about one year). The q 3 week trastuzumab may be started from 1-3 weeks after the last dose of paclitaxel. A total of 15 infusions of trastuzumab will be given q 3 weeks after the completion of paclitaxel during the HL phase. Lapatinib will be given orally at 1000 mg daily, starting with paclitaxel during the THL phase & continued for the remaining year during the HL phase for about a year.

Paclitaxel

Overall Number of Participants Analyzed 20
Measure Type: Count of Participants
Unit of Measure: Participants
Did not complete treatment
16
  80.0%
Successfully completed treatment
4
  20.0%
2.Secondary Outcome
Title Participants Toxicity Evaluated While on Study Treatment
Hide Description All toxicities following chemotherapy will be graded using the National Cancer Institute - Common Toxicity Criteria version 4.0.
Time Frame 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Paclitaxel With Trastuzumab and Lapatinib
Hide Arm/Group Description:

Paclitaxel (T) at 175 mg/m2 q 2 weeks x 4 with filgrastim/pegfilgrastim + trastuzumab (H) + daily oral lapatinib (L), followed by trastuzumab q 3 weeks x 15 doses + daily oral lapatinib (HL). Pegfilgrastim 6mg will be given subcutaneously (SQ) on day # 2 of each paclitaxel administration. Filgrastim may be used in lieu of pegfilgrastim at physician's discretion. Trastuzumab will be administered weekly (4 mg/kg bolus followed by 2 mg/kg weekly) starting with paclitaxel treatment cycle # 1. After 4 cycles of paclitaxel, pts will receive trastuzumab on a q 3 weeks x 15 doses (to complete about one year). The q 3 week trastuzumab may be started from 1-3 weeks after the last dose of paclitaxel. A total of 15 infusions of trastuzumab will be given q 3 weeks after the completion of paclitaxel during the HL phase. Lapatinib will be given orally at 1000 mg daily, starting with paclitaxel during the THL phase & continued for the remaining year during the HL phase for about a year.

Paclitaxel

Overall Number of Participants Analyzed 20
Measure Type: Count of Participants
Unit of Measure: Participants
20
 100.0%
Time Frame 1 year
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Paclitaxel With Trastuzumab and Lapatinib
Hide Arm/Group Description

Paclitaxel (T) at 175 mg/m2 q 2 weeks x 4 with filgrastim/pegfilgrastim + trastuzumab (H) + daily oral lapatinib (L), followed by trastuzumab q 3 weeks x 15 doses + daily oral lapatinib (HL). Pegfilgrastim 6mg will be given subcutaneously (SQ) on day # 2 of each paclitaxel administration. Filgrastim may be used in lieu of pegfilgrastim at physician's discretion. Trastuzumab will be administered weekly (4 mg/kg bolus followed by 2 mg/kg weekly) starting with paclitaxel treatment cycle # 1. After 4 cycles of paclitaxel, pts will receive trastuzumab on a q 3 weeks x 15 doses (to complete about one year). The q 3 week trastuzumab may be started from 1-3 weeks after the last dose of paclitaxel. A total of 15 infusions of trastuzumab will be given q 3 weeks after the completion of paclitaxel during the HL phase. Lapatinib will be given orally at 1000 mg daily, starting with paclitaxel during the THL phase & continued for the remaining year during the HL phase for about a year.

Paclitaxel

All-Cause Mortality
Paclitaxel With Trastuzumab and Lapatinib
Affected / at Risk (%)
Total   0/20 (0.00%) 
Hide Serious Adverse Events
Paclitaxel With Trastuzumab and Lapatinib
Affected / at Risk (%)
Total   4/20 (20.00%) 
General disorders   
Fatigue   1/20 (5.00%) 
Fever   1/20 (5.00%) 
Hepatobiliary disorders   
Hepatic failure   1/20 (5.00%) 
Infections and infestations   
Breast infection   1/20 (5.00%) 
Investigations   
Alanine aminotransferase increased   1/20 (5.00%) 
Aspartate aminotransferase increased   1/20 (5.00%) 
Creatinine increased   1/20 (5.00%) 
Metabolism and nutrition disorders   
Dehydration   1/20 (5.00%) 
Nervous system disorders   
Transient ischemic attacks   1/20 (5.00%) 
Vascular disorders   
Hypertension   1/20 (5.00%) 
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Paclitaxel With Trastuzumab and Lapatinib
Affected / at Risk (%)
Total   20/20 (100.00%) 
Blood and lymphatic system disorders   
Anemia   7/20 (35.00%) 
Eye disorders   
Dry eye   2/20 (10.00%) 
Blurred vision   1/20 (5.00%) 
Conjunctivitis   1/20 (5.00%) 
Watering eyes   1/20 (5.00%) 
Gastrointestinal disorders   
Diarrhea   16/20 (80.00%) 
Mucositis oral   8/20 (40.00%) 
Nausea   7/20 (35.00%) 
Dyspepsia   6/20 (30.00%) 
Constipation   4/20 (20.00%) 
Dysphagia   2/20 (10.00%) 
Gastrointestinal disorders - Other, specify   2/20 (10.00%) 
Vomiting   2/20 (10.00%) 
Anal hemorrhage   1/20 (5.00%) 
General disorders   
Fatigue   16/20 (80.00%) 
Pain   8/20 (40.00%) 
Fever   6/20 (30.00%) 
Chills   3/20 (15.00%) 
Edema limbs   3/20 (15.00%) 
Immune system disorders   
Allergic reaction   1/20 (5.00%) 
Infections and infestations   
Nail infection   1/20 (5.00%) 
Paronychia   1/20 (5.00%) 
Rash pustular   1/20 (5.00%) 
Rhinitis infective   1/20 (5.00%) 
Skin infection   1/20 (5.00%) 
Investigations   
Alanine aminotransferase increased   8/20 (40.00%) 
Alkaline phosphatase increased   6/20 (30.00%) 
Aspartate aminotransferase increased   4/20 (20.00%) 
Blood bilirubin increased   3/20 (15.00%) 
Weight loss   3/20 (15.00%) 
White blood cell decreased   2/20 (10.00%) 
Creatinine increased   1/20 (5.00%) 
INR increased   1/20 (5.00%) 
Lymphocyte count decreased   1/20 (5.00%) 
Weight gain   1/20 (5.00%) 
Metabolism and nutrition disorders   
Hyperglycemia   4/20 (20.00%) 
Hypoalbuminemia   4/20 (20.00%) 
Anorexia   3/20 (15.00%) 
Hypocalcemia   3/20 (15.00%) 
Dehydration   2/20 (10.00%) 
Hyperkalemia   2/20 (10.00%) 
Hypoglycemia   2/20 (10.00%) 
Hypernatremia   1/20 (5.00%) 
Hypokalemia   1/20 (5.00%) 
Metabolism and nutrition disorders-Other   1/20 (5.00%) 
Musculoskeletal and connective tissue disorders   
Bone pain   8/20 (40.00%) 
Arthralgia   4/20 (20.00%) 
Musculoskeletal & conn tissue disorder Other, spec   4/20 (20.00%) 
Joint range of motion decreased   2/20 (10.00%) 
Arthritis   1/20 (5.00%) 
Muscle weakness lower limb   1/20 (5.00%) 
Nervous system disorders   
Peripheral sensory neuropathy   12/20 (60.00%) 
Dizziness   6/20 (30.00%) 
Headache   3/20 (15.00%) 
Memory impairment   3/20 (15.00%) 
Nervous system disorders - Other, specify   3/20 (15.00%) 
Dysgeusia   2/20 (10.00%) 
Ataxia   1/20 (5.00%) 
Peripheral motor neuropathy   1/20 (5.00%) 
Transient ischemic attacks   1/20 (5.00%) 
Psychiatric disorders   
Anxiety   1/20 (5.00%) 
Psychiatric disorders - Other, specify   1/20 (5.00%) 
Renal and urinary disorders   
Urinary frequency   2/20 (10.00%) 
Renal and urinary disorders - Other   1/20 (5.00%) 
Reproductive system and breast disorders   
Irregular menstruation   5/20 (25.00%) 
Vaginal dryness   2/20 (10.00%) 
Breast pain   1/20 (5.00%) 
Respiratory, thoracic and mediastinal disorders   
Cough   3/20 (15.00%) 
Dyspnea   3/20 (15.00%) 
Postnasal drip   3/20 (15.00%) 
Epistaxis   2/20 (10.00%) 
Allergic rhinitis   1/20 (5.00%) 
Resp, thoracic & mediastinal disorder - Other   1/20 (5.00%) 
Skin and subcutaneous tissue disorders   
Skin & subcutaneous tissue disorders Other, spec   16/20 (80.00%) 
Alopecia   11/20 (55.00%) 
Rash acneiform   9/20 (45.00%) 
Pruritus   5/20 (25.00%) 
Dry skin   4/20 (20.00%) 
Rash maculo-papular   3/20 (15.00%) 
Nail loss   2/20 (10.00%) 
Palmar-plantar erythrodysesthesia syndrome   2/20 (10.00%) 
Nail ridging   1/20 (5.00%) 
Urticaria   1/20 (5.00%) 
Vascular disorders   
Hot flashes   8/20 (40.00%) 
Hypertension   2/20 (10.00%) 
Indicates events were collected by systematic assessment
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Chau Dang, MD
Organization: Memorial Sloan Kettering Cancer Center
Phone: 914-367-7181
EMail: dangc@mskcc.org
Layout table for additonal information
Responsible Party: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT01827163    
Other Study ID Numbers: 13-002
First Submitted: April 2, 2013
First Posted: April 9, 2013
Results First Submitted: December 4, 2019
Results First Posted: December 18, 2019
Last Update Posted: December 18, 2019