Phase II Study in Patients With Operable Breast Cancer
Primary Purpose
Breast Cancer
Status
Unknown status
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Pegylated Liposomal Doxorubicin (Doxil)
Sponsored by
About this trial
This is an interventional treatment trial for Breast Cancer focused on measuring Breast cancer, Over-expressing Her2-neu
Eligibility 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
Sites / Locations
- Providence St. Joseph Medical Hospital
- Cedars-Sinai Outpatient Cancer Center
- Desert Regional Medical Center Comprehensive Cancer Center
- Lynn Regional Cancer Center West
- John H. Stroger, Jr. Hospital of Cook County
- Maimonides Cancer Center
- Roswell Park Cancer Institute
- St Vincent Comprehensive Cancer Center
- University of Cincinnati
Outcomes
Primary Outcome Measures
Identify the pCR rate of neoadjuvant chemotherapy using the proposed 18-week regimen of PLD + paclitaxel + trastuzumab
Secondary Outcome Measures
Identify the complete response rate
Identify the partial response rate
Identify the overall response rate
Evaluate changes in cardiac function
Monitor safety and tolerability of neoadjuvant chemotherapy using the proposed 18 week regimen
Full Information
NCT ID
NCT00518583
First Posted
August 16, 2007
Last Updated
January 14, 2010
Sponsor
Aptium Oncology Research Network
Collaborators
Ortho Biotech Products, L.P.
1. Study Identification
Unique Protocol Identification Number
NCT00518583
Brief Title
Phase II Study in Patients With Operable Breast Cancer
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 Type
Interventional
2. Study Status
Record Verification Date
January 2010
Overall Recruitment Status
Unknown status
Study Start Date
October 2006 (undefined)
Primary Completion Date
January 2009 (Anticipated)
Study Completion Date
September 2009 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Aptium Oncology Research Network
Collaborators
Ortho Biotech Products, L.P.
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
Breast cancer, Over-expressing Her2-neu
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Pegylated Liposomal Doxorubicin (Doxil)
Other Intervention Name(s)
taxol (paclitaxel), herceptin
Intervention Description
Doxorubicin administered once every three weeks Taxol administered weekly Herceptin administered weekly
Primary Outcome Measure Information:
Title
Identify the pCR rate of neoadjuvant chemotherapy using the proposed 18-week regimen of PLD + paclitaxel + trastuzumab
Time Frame
within 18 weeks
Secondary Outcome Measure Information:
Title
Identify the complete response rate
Time Frame
within 18 weeks
Title
Identify the partial response rate
Time Frame
within 18 weeks
Title
Identify the overall response rate
Time Frame
within 18 weeks
Title
Evaluate changes in cardiac function
Time Frame
within study participation
Title
Monitor safety and tolerability of neoadjuvant chemotherapy using the proposed 18 week regimen
Time Frame
within study participation
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John Macdonald, MD
Organizational Affiliation
CMO Aptium Oncology
Official's Role
Study Director
Facility Information:
Facility Name
Providence St. Joseph Medical Hospital
City
Burbank
State/Province
California
ZIP/Postal Code
91505
Country
United States
Facility Name
Cedars-Sinai Outpatient Cancer Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Facility Name
Desert Regional Medical Center Comprehensive Cancer Center
City
Palm Springs
State/Province
California
ZIP/Postal Code
92262
Country
United States
Facility Name
Lynn Regional Cancer Center West
City
Boca Raton
State/Province
Florida
ZIP/Postal Code
33486
Country
United States
Facility Name
John H. Stroger, Jr. Hospital of Cook County
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
Maimonides Cancer Center
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11220
Country
United States
Facility Name
Roswell Park Cancer Institute
City
Buffalo
State/Province
New York
ZIP/Postal Code
14263
Country
United States
Facility Name
St Vincent Comprehensive Cancer Center
City
New York City
State/Province
New York
ZIP/Postal Code
10011
Country
United States
Facility Name
University of Cincinnati
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45221
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Phase II Study in Patients With Operable Breast Cancer
We'll reach out to this number within 24 hrs