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Phase II Study in Patients With Operable Breast Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00518583
Recruitment Status : Unknown
Verified January 2010 by Aptium Oncology Research Network.
Recruitment status was:  Active, not recruiting
First Posted : August 20, 2007
Last Update Posted : January 15, 2010
Ortho Biotech Products, L.P.
Information provided by:
Aptium Oncology Research Network

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Breast Cancer Drug: Pegylated Liposomal Doxorubicin (Doxil) Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Study of Pre-Operative Pegylated Liposomal Doxorubicin (PLD), Paclitaxel, and Trastuzumab in Patients With Operable Breast Cancer Over-expressing Her2-neu
Study Start Date : October 2006
Estimated Primary Completion Date : January 2009
Estimated Study Completion Date : September 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Intervention Details:
  • Drug: Pegylated Liposomal Doxorubicin (Doxil)
    Doxorubicin administered once every three weeks Taxol administered weekly Herceptin administered weekly
    Other Names:
    • taxol (paclitaxel)
    • herceptin

Primary Outcome Measures :
  1. Identify the pCR rate of neoadjuvant chemotherapy using the proposed 18-week regimen of PLD + paclitaxel + trastuzumab [ Time Frame: within 18 weeks ]

Secondary Outcome Measures :
  1. Identify the complete response rate [ Time Frame: within 18 weeks ]
  2. Identify the partial response rate [ Time Frame: within 18 weeks ]
  3. Identify the overall response rate [ Time Frame: within 18 weeks ]
  4. Evaluate changes in cardiac function [ Time Frame: within study participation ]
  5. Monitor safety and tolerability of neoadjuvant chemotherapy using the proposed 18 week regimen [ Time Frame: within study participation ]

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00518583

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United States, California
Providence St. Joseph Medical Hospital
Burbank, California, United States, 91505
Cedars-Sinai Outpatient Cancer Center
Los Angeles, California, United States, 90048
Desert Regional Medical Center Comprehensive Cancer Center
Palm Springs, California, United States, 92262
United States, Florida
Lynn Regional Cancer Center West
Boca Raton, Florida, United States, 33486
United States, Illinois
John H. Stroger, Jr. Hospital of Cook County
Chicago, Illinois, United States, 60612
United States, New York
Maimonides Cancer Center
Brooklyn, New York, United States, 11220
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263
St Vincent Comprehensive Cancer Center
New York City, New York, United States, 10011
United States, Ohio
University of Cincinnati
Cincinnati, Ohio, United States, 45221
Sponsors and Collaborators
Aptium Oncology Research Network
Ortho Biotech Products, L.P.
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Study Director: John Macdonald, MD CMO Aptium Oncology

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Responsible Party: Marti McKinley, Aptium Oncology Research Network Identifier: NCT00518583     History of Changes
Other Study ID Numbers: 06BR01
First Posted: August 20, 2007    Key Record Dates
Last Update Posted: January 15, 2010
Last Verified: January 2010

Keywords provided by Aptium Oncology Research Network:
Breast cancer
Over-expressing Her2-neu

Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Liposomal doxorubicin
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antibiotics, Antineoplastic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Antineoplastic Agents, Immunological