Phase II Study in Patients With Operable Breast Cancer

January 14, 2010 updated by: Aptium Oncology Research Network

A Phase II Study of Pre-Operative Pegylated Liposomal Doxorubicin (PLD), Paclitaxel, and Trastuzumab in Patients With Operable Breast Cancer Over-expressing Her2-neu

The study will evaluate the safety and efficacy of the combination PLD, paclitaxel, and trastuzumab in patients with operable breast cancer. Patients will be treated with the combination for 18 weeks, followed by surgery.

Study Overview

Status

Unknown

Conditions

Breast Cancer

Intervention / Treatment

Drug: Pegylated Liposomal Doxorubicin (Doxil)

Study Type

Interventional

Enrollment (Anticipated)

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
- California
  - Burbank, California, United States, 91505
    - Providence St. Joseph Medical Hospital
  - Los Angeles, California, United States, 90048
    - Cedars-Sinai Outpatient Cancer Center
  - Palm Springs, California, United States, 92262
    - Desert Regional Medical Center Comprehensive Cancer Center
- Florida
  - Boca Raton, Florida, United States, 33486
    - Lynn Regional Cancer Center West
- Illinois
  - Chicago, Illinois, United States, 60612
    - John H. Stroger, Jr. Hospital of Cook County
- New York
  - Brooklyn, New York, United States, 11220
    - Maimonides Cancer Center
  - Buffalo, New York, United States, 14263
    - Roswell Park Cancer Institute
  - New York City, New York, United States, 10011
    - St Vincent Comprehensive Cancer Center
- Ohio
  - Cincinnati, Ohio, United States, 45221
    - University of Cincinnati

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

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

Female

Description

Inclusion Criteria:

Dx of clinical T1c-T3, N0-1, M0 breast cancer
Interval between diagnosis and consent of <- 62 days
Life expectancy of 10 years
LVEF by MUGA >= lower limit of normal for the testing facility
Negative serum pregnancy test
Adequate bone marrow, renal, liver function
Negative bone scan
HRT discontinued before study entry
Adequate contraceptive methods

Exclusion Criteria:

Male breast cancer
Less than 21 years of age
Ulceration, infiltration of the skin, complete fixation or severe skin edema
N3 disease in which nodes are matted and fixed
Suspicious palpable supraclavicular nodes
CT evidence of malignant internal mammary nodes
Pregnancy or breast feeding at time of study entry
Prior therapy for breast cancer
Prior anthracycline for any malignancy
Prior breast malignancy of the contralateral breast
Prior non-breast malignancy within 5 years
Non-malignant disease that would preclude follow up
MI within 6 months, NYHA Class II or greater heart failure
Psychiatric disorders or conditions that would preclude provision of informed consent

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	Time Frame
Identify the pCR rate of neoadjuvant chemotherapy using the proposed 18-week regimen of PLD + paclitaxel + trastuzumab Time Frame: within 18 weeks	within 18 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
Identify the complete response rate Time Frame: within 18 weeks	within 18 weeks
Identify the partial response rate Time Frame: within 18 weeks	within 18 weeks
Identify the overall response rate Time Frame: within 18 weeks	within 18 weeks
Evaluate changes in cardiac function Time Frame: within study participation	within study participation
Monitor safety and tolerability of neoadjuvant chemotherapy using the proposed 18 week regimen Time Frame: within study participation	within study participation

Collaborators and Investigators

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

Sponsor

Aptium Oncology Research Network

Collaborators

Ortho Biotech Products, L.P.

Investigators

Study Director: John Macdonald, MD, CMO Aptium Oncology

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

October 1, 2006

Primary Completion (Anticipated)

January 1, 2009

Study Completion (Anticipated)

September 1, 2009

Study Registration Dates

First Submitted

August 16, 2007

First Submitted That Met QC Criteria

August 17, 2007

First Posted (Estimate)

August 20, 2007

Study Record Updates

Last Update Posted (Estimate)

January 15, 2010

Last Update Submitted That Met QC Criteria

January 14, 2010

Last Verified

January 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

06BR01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.