Neoadjuvant Therapy With Herceptin and Taxol for Breast Cancer

February 15, 2013 updated by: Harold J. Burstein, MD, PhD

Neoadjuvant Therapy With Herceptin and Taxol for Stage II/III Breast Cancer

The purpose of this study is to determine the effectiveness and safety of administering Herceptin in combination with Taxol (paclitaxel) in the treatment of women with HER2-positive, early stage breast cancer prior to surgery.

Study Overview

Status

Completed

Conditions

Breast Cancer

Intervention / Treatment

Detailed Description

Patients will receive Herceptin intravenously once weekly for 12 weeks, and Taxol intravenously every 3 weeks (week 1, week 4, week 7 and week 10).

After 12 weeks of treatment, breast surgery will be performed (either a lumpectomy or a mastectomy).

Once patients have recovered from the surgery, they will receive adriamycin and cytoxan every 3 weeks for 4 cycles (12 weeks total).

After Herceptin and Taxol therapy, tumor assessment will be performed along with an echocardiogram and mammogram.

At the time of surgery, re-assessment of the tumor will be done.

Blood work will be performed on day one of each chemotherapy cycle.

Study Type

Interventional

Enrollment (Actual)

Phase

Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

United States
- Massachusetts
  - Boston, Massachusetts, United States, 02115
    - Dana-Farber Cancer Institute
  - Boston, Massachusetts, United States, 02115
    - Massachusetts General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Description

Inclusion Criteria:

Patients must have Stage II or III histologically diagnosed breast cancer
Primary invasive breast cancers that overexpress the HER2/neu oncogene
Age older than 18 years
Eastern Cooperative Oncology Group (ECOG) performance status of < 1
White blood cell (WBC) > 4000/mm3
Platelet count > 100,000/mm3
Bilirubin < 1 x upper limit of normal (ULN)
SGOT < 1 x ULN
Creatinine < 1.5mg/dl
Normal cardiac function and electrocardiogram (EKG) showing absence of ischemic changes or ventricular hypertrophy

Exclusion Criteria:

Excisional biopsy, sentinel node dissection or axillary node dissection.
Prior history of breast cancer unless: diagnosed at least 2 years ago, present cancer is not in a previously irradiated breast, no prior therapy with anthracycline or taxane, no prior high-dose chemotherapy with stem cell or bone marrow transplant.
Pregnant or breast-feeding women
Uncontrolled infection
Active or severe cardiovascular or pulmonary disease
Peripheral neuropathy of any etiology that exceeds grade 1
Prior history of malignancy treated without curative intent
Uncontrolled diabetes

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Interventional Model: Single Group Assignment
Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
To determine the response of HER2-positive breast cancer to treatment with Herceptin and Taxol prior to surgery

Secondary Outcome Measures

Outcome Measure	Time Frame
To examine the safety of Herceptin and Taxol therapy followed by surgery and chemotherapy Time Frame: 3 years	3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Harold J. Burstein, MD, PhD

Collaborators

Bristol-Myers Squibb

Massachusetts General Hospital

Dana-Farber Cancer Institute

Beth Israel Deaconess Medical Center

Genentech, Inc.

Brigham and Women's Hospital

Harvard Vanguard Medical Associates

Investigators

Principal Investigator: Harold Burstein, MD, PhD, Dana-Farber Cancer Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 1999

Primary Completion (Actual)

November 1, 2006

Study Completion (Actual)

March 1, 2012

Study Registration Dates

First Submitted

August 26, 2005

First Submitted That Met QC Criteria