Doxorubicin and Cyclophosphamide Followed By Trastuzumab, Paclitaxel, and Lapatinib in Treating Patients With Early-Stage HER2-Positive Breast Cancer That Has Been Removed By Surgery

Part of paid clinical trials in Rochester, Minnesota.

Sponsor: Mayo Clinic
Study ID: NCT00436566
Phase: PHASE2
Status: Completed

Conditions

Breast Cancer
Cardiac Toxicity

Eligibility Criteria

Sex: ALL
Age: 18 Years - 120 Years
Healthy Volunteers: Not accepted

Interventions

trastuzumab — BIOLOGICAL
cyclophosphamide — DRUG
doxorubicin hydrochloride — DRUG
lapatinib ditosylate — DRUG
paclitaxel — DRUG
gene expression analysis — GENETIC
reverse transcriptase-polymerase chain reaction — GENETIC
fluorophotometry — OTHER
laboratory biomarker analysis — OTHER
mass spectrometry — OTHER
adjuvant therapy — PROCEDURE
quality-of-life assessment — PROCEDURE

Study Details

RATIONALE: Drugs used in chemotherapy, such as doxorubicin, cyclophosphamide, and paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as trastuzumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Lapatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving combination chemotherapy together with trastuzumab and lapatinib after surgery may kill any tumor cells that remain after surgery. PURPOSE: This randomized phase II trial is studying the side effects and how well giving doxorubicin together with cyclophosphamide followed by trastuzumab, paclitaxel, and lapatinib works in treating patients with early-stage HER2-positive breast cancer that has been removed by surgery.