Phase II Study in Patients With Operable Breast Cancer

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): 30
• Phase: Phase 2

Contacts and Locations

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

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• 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

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	within 18 weeks

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Aptium Oncology Research Network
• Collaborators: Ortho Biotech Products, L.P.
• Investigators: Study Director: John Macdonald, MD, CMO Aptium Oncology

Study record dates

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: Breast cancer; Over-expressing Her2-neu
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antineoplastic Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Antineoplastic Agents, Phytogenic; Topoisomerase II Inhibitors; Topoisomerase Inhibitors; Antibiotics, Antineoplastic; Paclitaxel; Doxorubicin; Liposomal doxorubicin
• Other Study ID Numbers: 06BR01