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Trial record 83 of 125 for:    lapatinib | Recruiting, Active, not recruiting, Completed Studies | Phase 2

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

Tracking Information
First Submitted Date  ICMJE June 4, 2007
First Posted Date  ICMJE June 5, 2007
Results First Submitted Date  ICMJE December 22, 2015
Results First Posted Date  ICMJE March 13, 2017
Last Update Posted Date May 12, 2017
Study Start Date  ICMJE March 2007
Actual Primary Completion Date July 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 23, 2017)
Number of Patients Who Completed All Planned Therapy [ Time Frame: 2 years ]
The number of patients who completed all planned therapy (dose-dense adjuvant/ neoadjuvant chemotherapy regimen) in HER-2/neu-overexpressed/ amplified breast cancer patients.
Original Primary Outcome Measures  ICMJE
 (submitted: June 4, 2007)
Feasibility
Change History Complete list of historical versions of study NCT00482391 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 6, 2017)
Number of Patients Who Were Evaluated for Toxicity [ Time Frame: 2 years ]
Please see adverse event section in the results. Toxicities were assessed by the National Cancer Institute Common Toxicity Criteria (NCI CTC) version 3.0.
Original Secondary Outcome Measures  ICMJE
 (submitted: June 4, 2007)
  • Toxicity
  • Time to recurrence
  • Overall survival
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Doxorubicin and Cyclophosphamide Followed by Paclitaxel, Trastuzumab, and Lapatinib in Treating Patients With HER2/Neu-Overexpressed Breast Cancer
Official Title  ICMJE Phase II Study of Dose-Dense Doxorubicin and Cyclophosphamide (AC) Followed by Weekly Paclitaxel With Trastuzumab and Lapatinib in HER2/NEU-Overexpressed/Amplified Breast Cancer: Feasibility
Brief Summary The purpose of this study is to study a new treatment for HER-2/neu (+) breast cancer.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Breast Cancer
Intervention  ICMJE
  • Biological: trastuzumab
  • Drug: cyclophosphamide
  • Drug: doxorubicin hydrochloride
  • Drug: lapatinib ditosylate
  • Drug: paclitaxel
  • Other: laboratory biomarker analysis
Study Arms  ICMJE Experimental: AC, PACLITAXEL , TRASTUZUMAB & LAPATINIB
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.
Interventions:
  • Biological: trastuzumab
  • Drug: cyclophosphamide
  • Drug: doxorubicin hydrochloride
  • Drug: lapatinib ditosylate
  • Drug: paclitaxel
  • Other: laboratory biomarker analysis
Publications * Dang C, Lin N, Moy B, Come S, Sugarman S, Morris P, Abbruzzi A, Chen C, Steingart R, Patil S, Norton L, Winer E, Hudis C. Dose-dense doxorubicin and cyclophosphamide followed by weekly paclitaxel with trastuzumab and lapatinib in HER2/neu-overexpressed/amplified breast cancer is not feasible because of excessive diarrhea. J Clin Oncol. 2010 Jun 20;28(18):2982-8. doi: 10.1200/JCO.2009.26.5900. Epub 2010 May 17. Erratum in: J Clin Oncol. 2010 Aug 1;28(22):3670.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 6, 2013)
95
Original Enrollment  ICMJE
 (submitted: June 4, 2007)
100
Actual Study Completion Date  ICMJE July 2011
Actual Primary Completion Date July 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

DISEASE CHARACTERISTICS:

  • Histologically confirmed adenocarcinoma of the breast

    • Bilateral synchronous breast tumors allowed
    • Any nodal status or tumor size allowed

      • No stage IV disease
  • HER2/neu-positive disease

    • 3+ by IHC OR FISH-amplified
  • Hormone receptor status not specified

PATIENT CHARACTERISTICS:

  • Male or female
  • Menopausal status not specified
  • ECOG performance status 0-1
  • Absolute neutrophil count ≥ 1,000/mm³
  • Platelet count ≥ 100,000/mm³
  • Bilirubin ≤ 1.1 mg/dL
  • SGOT or SGPT ≤ 2.5 times upper limit of normal (ULN)
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective barrier contraception during and after completion of study therapy
  • LVEF ≥ 50% by MUGA scan
  • No peripheral neuropathy > grade 1
  • No active second malignancy within the past 5 years except for adequately treated nonmelanoma skin cancer or in situ carcinoma of the cervix
  • No known allergy or hypersensitivity to doxorubicin hydrochloride, cyclophosphamide, paclitaxel, or other drugs formulated in Cremophor EL
  • No psychiatric illness or concurrent medical conditions that would preclude study treatment
  • No other conditions, including any of the following:

    • Unstable angina
    • Congestive heart failure
    • Myocardial infarction within the past 12 months
    • High-risk uncontrolled arrhythmias (e.g., ventricular tachycardia, high-grade AV block, or supraventricular arrhythmias that are not adequately controlled)
  • No QT prolongation (> 500 ms)
  • No active unresolved infections
  • No sensitivity to E. coli derived proteins

PRIOR CONCURRENT THERAPY:

  • Prior hormonal therapy for chemoprevention allowed
  • No prior trastuzumab (Herceptin®)
  • No prior anthracyclines
  • No concurrent hormonal therapy, including hormonal contraception (e.g., birth control pills or ovarian hormonal or replacement therapy)
  • No other concurrent chemotherapy, radiotherapy, immunotherapy, or biotherapy for breast cancer
  • No concurrent drugs that may prolong the QT
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 120 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00482391
Other Study ID Numbers  ICMJE 07-013
MSKCC-07013
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Memorial Sloan Kettering Cancer Center
Study Sponsor  ICMJE Memorial Sloan Kettering Cancer Center
Collaborators  ICMJE
  • National Cancer Institute (NCI)
  • Dana-Farber Cancer Institute
  • GlaxoSmithKline
Investigators  ICMJE
Principal Investigator: Chau T. Dang, MD Memorial Sloan Kettering Cancer Center
Principal Investigator: Clifford A. Hudis, MD Memorial Sloan Kettering Cancer Center
PRS Account Memorial Sloan Kettering Cancer Center
Verification Date April 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP