Phase 2 N=95 Treatment

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

Breast Cancer

Bottom Line

View on ClinicalTrials.gov: NCT00482391 ↗

Enrolled (actual)

Serious AEs

24.2%

Results posted

Mar 2017

Primary outcome: Primary: Number of Patients Who Completed All Planned Therapy — 45 participants

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: trastuzumab (Biological); cyclophosphamide (Drug); doxorubicin hydrochloride (Drug); lapatinib ditosylate (Drug); paclitaxel (Drug); laboratory biomarker analysis (Other)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Memorial Sloan Kettering Cancer Center
Primary completion: Jul 2011

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Patients Who Completed All Planned Therapy	45	—
SECONDARY Number of Patients Who Were Evaluated for Toxicity	95	—

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00482391). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.