Clinical trial NCT00482391: Doxorubicin and Cyclophosphamide Followed by Paclitaxel, Trastuzumab, and Lapatinib in Treating Patients With HER2/Neu-Overexpressed Breast Cancer
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Breast Cancer
Keywords: 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
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
name: Dana-Farber Cancer Institute
name: GlaxoSmithKline
First posted: 2007-06-05
Enrollment: 95
Sex: ALL
Minimum age (years): 18
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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


Eligibility criteria: 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

Primary outcomes:
measure: Number of Patients Who Completed All Planned Therapy
timeFrame: 2 years
Secondary outcomes:
measure: Number of Patients Who Were Evaluated for Toxicity
timeFrame: 2 years
Other outcomes:
Locations:
city: Boston
country: United States
facility: Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute
state: Massachusetts
city: New York
country: United States
facility: Memorial Sloan-Kettering Cancer Center
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Chau T. Dang, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Memorial Sloan Kettering Cancer Center
name: Clifford A. Hudis, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.