Phase II Study in Patients With Operable Breast Cancer

NCT ID: NCT00518583

Last Updated: 2010-01-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-10-31

Study Completion Date

2009-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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Breast Cancer

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Pegylated Liposomal Doxorubicin (Doxil)

Doxorubicin administered once every three weeks Taxol administered weekly Herceptin administered weekly

Intervention Type DRUG

Other Intervention Names

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taxol (paclitaxel) herceptin

Eligibility Criteria

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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
Minimum Eligible Age

21 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Ortho Biotech Products, L.P.

INDUSTRY

Sponsor Role collaborator

Aptium Oncology Research Network

NETWORK

Sponsor Role lead

Responsible Party

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Aptium Oncology Research Network

Principal Investigators

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John Macdonald, MD

Role: STUDY_DIRECTOR

CMO Aptium Oncology

Locations

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Providence St. Joseph Medical Hospital

Burbank, California, United States

Site Status

Cedars-Sinai Outpatient Cancer Center

Los Angeles, California, United States

Site Status

Desert Regional Medical Center Comprehensive Cancer Center

Palm Springs, California, United States

Site Status

Lynn Regional Cancer Center West

Boca Raton, Florida, United States

Site Status

John H. Stroger, Jr. Hospital of Cook County

Chicago, Illinois, United States

Site Status

Maimonides Cancer Center

Brooklyn, New York, United States

Site Status

Roswell Park Cancer Institute

Buffalo, New York, United States

Site Status

St Vincent Comprehensive Cancer Center

New York, New York, United States

Site Status

University of Cincinnati

Cincinnati, Ohio, United States

Site Status

Countries

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United States

Other Identifiers

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06BR01

Identifier Type: -

Identifier Source: org_study_id

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