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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
Information provided by (Responsible Party):

Study Description
Brief Summary:
The purpose of this study is to study a new treatment for HER-2/neu (+) breast cancer.

Condition or disease Intervention/treatment Phase
Breast Cancer Biological: trastuzumab Drug: cyclophosphamide Drug: doxorubicin hydrochloride Drug: lapatinib ditosylate Drug: paclitaxel Other: laboratory biomarker analysis Phase 2

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 95 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : March 2007
Primary Completion Date : July 2011
Study Completion Date : July 2011

Arms and Interventions

Arm Intervention/treatment
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.
Biological: trastuzumab Drug: cyclophosphamide Drug: doxorubicin hydrochloride Drug: lapatinib ditosylate Drug: paclitaxel Other: laboratory biomarker analysis

Outcome Measures

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. 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.

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 120 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • 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


  • 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 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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00482391

United States, Massachusetts
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02115
United States, New York
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10021
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center
National Cancer Institute (NCI)
Dana-Farber Cancer Institute
Principal Investigator: Chau T. Dang, MD Memorial Sloan Kettering Cancer Center
Principal Investigator: Clifford A. Hudis, MD Memorial Sloan Kettering Cancer Center
More Information

Responsible Party: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT00482391     History of Changes
Other Study ID Numbers: 07-013
First Posted: June 5, 2007    Key Record Dates
Results First Posted: March 13, 2017
Last Update Posted: May 12, 2017
Last Verified: April 2017

Keywords provided by Memorial Sloan Kettering Cancer Center:
recurrent breast cancer
stage I breast cancer
stage II breast cancer
stage IIIA breast cancer
stage IIIB breast cancer
stage IIIC breast cancer
male breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Liposomal doxorubicin
Albumin-Bound Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Myeloablative Agonists
Antibiotics, Antineoplastic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Protein Kinase Inhibitors