Trial ID or NCT#

NCT00486668

Status

not recruiting iconNOT RECRUITING

Purpose

The primary purpose of this study is to determine whether breast cancer tumors respond (as measured by pathologic complete response: the absence of microscopic evidence of invasive tumor cells in the breast) to combined chemotherapy of AC(doxorubicin and cyclophosphamide) followed by paclitaxel plus trastuzumab or lapatinib or both given before surgery to patients with HER2-positive breast cancer. Trastuzumab will also be given to all patients after surgery. The study will also evaluate the toxic effects of the chemotherapy combination, including effects on the heart, and will determine survival and progression-free survival 5 years after treatment. Also, the study will look at whether there are gene expression profiles in the tumor tissue that can predict pathologic complete response.

Official Title

A Randomized Phase III Trial of Neoadjuvant Therapy for Patients With Palpable and Operable HER2-Positive Breast Cancer Comparing the Combination of Trastuzumab Plus Lapatinib to Trastuzumab and to Lapatinib Administered With Weekly Paclitaxel Following AC Accompanied by Correlative Science Studies to Identify Predictors of Pathologic Complete Response

Eligibility Criteria

Ages Eligible for Study: Older than 18 Years
Sexes Eligible for Study: Female
Accepts Healthy Volunteers: No

Investigator(s)

Frank E. Stockdale
Frank E. Stockdale
Medical oncologist, Breast specialist
Maureen Lyles D'Ambrogio Professor in the School of Medicine, Emeritus
Robert W. Carlson
Irene Wapnir, MD
Irene Wapnir, MD
Surgical oncologist, Breast surgeon, Breast specialist
Professor of Surgery (General Surgery)

Contact us to find out if this trial is right for you.

CONTACT

Cancer Clinical Trials Office
(650) 498-7061