Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Memorial Sloan Kettering Cancer Center
With
National Cancer Institute (NCI)
Dana-Farber Cancer Institute
GlaxoSmithKline
Age
18–120
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
Clareo Health | Doxorubicin and Cyclophosphamide Followed by Paclitaxel, Trastuzumab, and Lapatinib in Treating Patients With HER2/Neu-Overexpressed Breast Cancer
