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Doxorubicin and Cyclophosphamide Followed by Paclitaxel, Trastuzumab, and Lapatinib in Treating Patients With HER2/Neu-Overexpressed Breast Cancer

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ClinicalTrials.gov Identifier: NCT00482391
Recruitment Status : Completed
First Posted : June 5, 2007
Results First Posted : March 13, 2017
Last Update Posted : May 12, 2017
Sponsor:
Collaborators:
National Cancer Institute (NCI)
Dana-Farber Cancer Institute
GlaxoSmithKline
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Breast Cancer
Interventions Biological: trastuzumab
Drug: cyclophosphamide
Drug: doxorubicin hydrochloride
Drug: lapatinib ditosylate
Drug: paclitaxel
Other: laboratory biomarker analysis
Enrollment 95
Recruitment Details  
Pre-assignment Details  
Arm/Group Title AC, PACLITAXEL , TRASTUZUMAB & LAPATINIB
Hide Arm/Group Description The regimen consists of AC (doxorubicin 60 mg/m2, cyclophosphamide 600 mg/m2) q 14 days x 4 with pegfilgrastim, followed by weekly paclitaxel (80 mg/m2) x 12 + trastuzumab (H) + lapatinib (L). Pegfilgrastim 6mg is given subcutaneously (SQ) on day # 2 of each AC. Filgrastim may be used in lieu of pegfilgrastim at the physician's discretion. Trastuzumab will be administered weekly starting with paclitaxel treatment # 1. Near the completion of all chemotherapy, patients may receive trastuzumab on a q 3-weekly schedule, starting as early as with paclitaxel cycle # 12. The total duration of trastuzumab from beginning to end is 52 weeks. Lapatinib will be given orally at 1000 mg daily, starting with trastuzumab for a total duration of 52 weeks. Hormonal therapy such as tamoxifen or an aromatase inhibitor will be given to patients with hormone receptor positive disease at the physician's discretion. Radiation therapy to the breast or chest is recommended to patients as appropriate.
Period Title: Overall Study
Started 95
Completed 92
Not Completed 3
Reason Not Completed
Withdrawal by Subject             1
Adverse Event             1
Death             1
Arm/Group Title AC, PACLITAXEL , TRASTUZUMAB & LAPATINIB
Hide Arm/Group Description The regimen consists of AC (doxorubicin 60 mg/m2, cyclophosphamide 600 mg/m2) q 14 days x 4 with pegfilgrastim, followed by weekly paclitaxel (80 mg/m2) x 12 + trastuzumab (H) + lapatinib (L). Pegfilgrastim 6mg is given subcutaneously (SQ) on day # 2 of each AC. Filgrastim may be used in lieu of pegfilgrastim at the physician's discretion. Trastuzumab will be administered weekly starting with paclitaxel treatment # 1. Near the completion of all chemotherapy, patients may receive trastuzumab on a q 3-weekly schedule, starting as early as with paclitaxel cycle # 12. The total duration of trastuzumab from beginning to end is 52 weeks. Lapatinib will be given orally at 1000 mg daily, starting with trastuzumab for a total duration of 52 weeks. Hormonal therapy such as tamoxifen or an aromatase inhibitor will be given to patients with hormone receptor positive disease at the physician's discretion. Radiation therapy to the breast or chest is recommended to patients as appropriate.
Overall Number of Baseline Participants 95
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 95 participants
<=18 years
0
   0.0%
Between 18 and 65 years
93
  97.9%
>=65 years
2
   2.1%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 95 participants
Female
94
  98.9%
Male
1
   1.1%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 95 participants
95
1.Primary Outcome
Title Number of Patients Who Completed All Planned Therapy
Hide Description The number of patients who completed all planned therapy (dose-dense adjuvant/ neoadjuvant chemotherapy regimen) in HER-2/neu-overexpressed/ amplified breast cancer patients.
Time Frame 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title AC, PACLITAXEL , TRASTUZUMAB & LAPATINIB
Hide Arm/Group Description:
The regimen consists of AC (doxorubicin 60 mg/m2, cyclophosphamide 600 mg/m2) q 14 days x 4 with pegfilgrastim, followed by weekly paclitaxel (80 mg/m2) x 12 + trastuzumab (H) + lapatinib (L). Pegfilgrastim 6mg is given subcutaneously (SQ) on day # 2 of each AC. Filgrastim may be used in lieu of pegfilgrastim at the physician's discretion. Trastuzumab will be administered weekly starting with paclitaxel treatment # 1. Near the completion of all chemotherapy, patients may receive trastuzumab on a q 3-weekly schedule, starting as early as with paclitaxel cycle # 12. The total duration of trastuzumab from beginning to end is 52 weeks. Lapatinib will be given orally at 1000 mg daily, starting with trastuzumab for a total duration of 52 weeks. Hormonal therapy such as tamoxifen or an aromatase inhibitor will be given to patients with hormone receptor positive disease at the physician's discretion. Radiation therapy to the breast or chest is recommended to patients as appropriate.
Overall Number of Participants Analyzed 92
Measure Type: Number
Unit of Measure: participants
45
2.Secondary Outcome
Title Number of Patients Who Were Evaluated for Toxicity
Hide Description Please see adverse event section in the results. Toxicities were assessed by the National Cancer Institute Common Toxicity Criteria (NCI CTC) version 3.0.
Time Frame 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Dose-dense Adjuvant/ Neoadjuvant Chemotherapy Regimen
Hide Arm/Group Description:
[Not Specified]
Overall Number of Participants Analyzed 95
Measure Type: Count of Participants
Unit of Measure: Participants
95
 100.0%
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title AC, PACLITAXEL , TRASTUZUMAB & LAPATINIB
Hide Arm/Group Description The regimen consists of AC (doxorubicin 60 mg/m2, cyclophosphamide 600 mg/m2) q 14 days x 4 with pegfilgrastim, followed by weekly paclitaxel (80 mg/m2) x 12 + trastuzumab (H) + lapatinib (L). Pegfilgrastim 6mg is given subcutaneously (SQ) on day # 2 of each AC. Filgrastim may be used in lieu of pegfilgrastim at the physician's discretion. Trastuzumab will be administered weekly starting with paclitaxel treatment # 1. Near the completion of all chemotherapy, patients may receive trastuzumab on a q 3-weekly schedule, starting as early as with paclitaxel cycle # 12. The total duration of trastuzumab from beginning to end is 52 weeks. Lapatinib will be given orally at 1000 mg daily, starting with trastuzumab for a total duration of 52 weeks. Hormonal therapy such as tamoxifen or an aromatase inhibitor will be given to patients with hormone receptor positive disease at the physician's discretion. Radiation therapy to the breast or chest is recommended to patients as appropriate.
All-Cause Mortality
AC, PACLITAXEL , TRASTUZUMAB & LAPATINIB
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
AC, PACLITAXEL , TRASTUZUMAB & LAPATINIB
Affected / at Risk (%) # Events
Total   23/95 (24.21%)    
Blood and lymphatic system disorders   
Edema: limb  1  1/95 (1.05%)  1
Hematoma  1  1/95 (1.05%)  1
Hemoglobin  1  2/95 (2.11%)  2
Leukocytes (total WBC)  1  1/95 (1.05%)  1
Cardiac disorders   
Hypertension  1  1/95 (1.05%)  1
Hypotension  1  2/95 (2.11%)  2
Left ventricular diastolic dysfunction  1  1/95 (1.05%)  1
Prolonged QTc interval  1  1/95 (1.05%)  1
Sinus tachycardia  1  1/95 (1.05%)  1
Eye disorders   
Ocular/Visual - Other (specify)  1  1/95 (1.05%)  1
Gastrointestinal disorders   
Dehydration  1  1/95 (1.05%)  1
Diarrhea  1  3/95 (3.16%)  3
Gastrointestinal, other  1  1/95 (1.05%)  1
Nausea  1  1/95 (1.05%)  1
General disorders   
Fatigue (asthenia, lethargy, malaise)  1  1/95 (1.05%)  1
Fever  1  4/95 (4.21%)  4
Flu-like syndrome  1  1/95 (1.05%)  1
Pain - Head/headache  1  1/95 (1.05%)  1
Pain - Muscle  1  1/95 (1.05%)  1
Pain - Other (specify)  1  1/95 (1.05%)  1
Rigors/chills  1  1/95 (1.05%)  1
Hepatobiliary disorders   
Liver dysfunction/failure  1  1/95 (1.05%)  1
Infections and infestations   
Inf norm ANC/gr1/2 neut-Cellulitis(skin)  1  2/95 (2.11%)  2
Inf norm ANC/gr1/2 neut-Gingivitis(oral-gums)  1  1/95 (1.05%)  1
Inf unknown ANC-Cellulitis(skin)  1  1/95 (1.05%)  1
Inf unknown ANC-Pneumonia(lung)  1  1/95 (1.05%)  1
Infection w/ Gr 3/4 neut, Catheter-related  1  1/95 (1.05%)  1
Infection w/ Gr 3/4 neut, Skin (cellulites)  1  1/95 (1.05%)  1
Infection, other  1  2/95 (2.11%)  2
Neutrophils/granulocytes (ANC/AGC)  1  1/95 (1.05%)  1
Metabolism and nutrition disorders   
Cholesterol,high(hypercholestremia)  1  1/95 (1.05%)  1
Respiratory, thoracic and mediastinal disorders   
Cough  1  1/95 (1.05%)  1
Dyspnea (shortness of breath)  1  6/95 (6.32%)  6
Pleural effusion (non-malig)  1  1/95 (1.05%)  1
Pneumonitis/pulm infiltrates  1  1/95 (1.05%)  1
Vascular disorders   
Thrombosis/embolism (vascular access-related)  1  1/95 (1.05%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTC-3.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
AC, PACLITAXEL , TRASTUZUMAB & LAPATINIB
Affected / at Risk (%) # Events
Total   94/95 (98.95%)    
Blood and lymphatic system disorders   
Hemoglobin  1  50/95 (52.63%) 
Leukocytes (total WBC)  1  37/95 (38.95%) 
Lymphopenia  1  38/95 (40.00%) 
Endocrine disorders   
Hot flashes/flushes  1  7/95 (7.37%) 
Gastrointestinal disorders   
Constipation  1  8/95 (8.42%) 
Diarrhea  1  50/95 (52.63%) 
Mucositis (Clin exam)- Oral cavity  1  12/95 (12.63%) 
Nausea  1  18/95 (18.95%) 
Vomiting  1  7/95 (7.37%) 
General disorders   
Fatigue (asthenia, lethargy, malaise)  1  49/95 (51.58%) 
Pain - Head/headache  1  7/95 (7.37%) 
Pain - Other (specify)  1  7/95 (7.37%) 
Infections and infestations   
Infection  1  16/95 (16.84%) 
Neutrophils/granulocytes (ANC/AGC)  1  26/95 (27.37%) 
Metabolism and nutrition disorders   
ALT, SGPT  1  22/95 (23.16%) 
AST, SGOT  1  10/95 (10.53%) 
Bilirubin (hyperbilirubinemia)  1  6/95 (6.32%) 
Glucose, high (hyperglycemia)  1  29/95 (30.53%) 
Nervous system disorders   
Neuropathy: sensory  1  16/95 (16.84%) 
Reproductive system and breast disorders   
Irregular menses (change from baseline)  1  9/95 (9.47%) 
Respiratory, thoracic and mediastinal disorders   
Cough  1  5/95 (5.26%) 
Dyspnea (shortness of breath)  1  6/95 (6.32%) 
Skin and subcutaneous tissue disorders   
Dermatology/Skin, other  1  8/95 (8.42%) 
Hair loss/alopecia (scalp or body)  1  24/95 (25.26%) 
Nail changes  1  7/95 (7.37%) 
Rash/desquamation  1  8/95 (8.42%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTC-3.0
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Dr. Chau Dang
Organization: Memorial Sloan Kettering Cancer Center
Phone: 914-367-7181
Responsible Party: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT00482391     History of Changes
Other Study ID Numbers: 07-013
MSKCC-07013
First Submitted: June 4, 2007
First Posted: June 5, 2007
Results First Submitted: December 22, 2015
Results First Posted: March 13, 2017
Last Update Posted: May 12, 2017