Phase II Study in Patients With Operable Breast Cancer

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2010 by Aptium Oncology Research Network.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Ortho Biotech Products, L.P.
Information provided by:
Aptium Oncology Research Network
ClinicalTrials.gov Identifier:
NCT00518583
First received: August 16, 2007
Last updated: January 14, 2010
Last verified: January 2010
  Purpose

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 Intervention Phase
Breast Cancer
Drug: Pegylated Liposomal Doxorubicin (Doxil)
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Aptium Oncology Research Network:

Primary Outcome Measures:
  • Identify the pCR rate of neoadjuvant chemotherapy using the proposed 18-week regimen of PLD + paclitaxel + trastuzumab [ Time Frame: within 18 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Identify the complete response rate [ Time Frame: within 18 weeks ] [ Designated as safety issue: No ]
  • Identify the partial response rate [ Time Frame: within 18 weeks ] [ Designated as safety issue: No ]
  • Identify the overall response rate [ Time Frame: within 18 weeks ] [ Designated as safety issue: No ]
  • Evaluate changes in cardiac function [ Time Frame: within study participation ] [ Designated as safety issue: Yes ]
  • Monitor safety and tolerability of neoadjuvant chemotherapy using the proposed 18 week regimen [ Time Frame: within study participation ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 30
Study Start Date: October 2006
Estimated Study Completion Date: September 2009
Estimated Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Pegylated Liposomal Doxorubicin (Doxil)
    Doxorubicin administered once every three weeks Taxol administered weekly Herceptin administered weekly
    Other Names:
    • taxol (paclitaxel)
    • herceptin
  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00518583

Locations
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.
Investigators
Study Director: John Macdonald, MD CMO Aptium Oncology
  More Information

No publications provided

Responsible Party: Marti McKinley, Aptium Oncology Research Network
ClinicalTrials.gov Identifier: NCT00518583     History of Changes
Other Study ID Numbers: 06BR01
Study First Received: August 16, 2007
Last Updated: January 14, 2010
Health Authority: United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on October 23, 2014