Phase II Study in Patients With Operable Breast Cancer
- Conditions
- Breast Cancer
- Registration Number
- NCT00518583
- Lead Sponsor
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- Female
- Target Recruitment
- 30
- 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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Identify the pCR rate of neoadjuvant chemotherapy using the proposed 18-week regimen of PLD + paclitaxel + trastuzumab within 18 weeks
- Secondary Outcome Measures
Name Time Method 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
Trial Locations
- Locations (9)
University of Cincinnati
🇺🇸Cincinnati, Ohio, United States
Providence St. Joseph Medical Hospital
🇺🇸Burbank, California, United States
Lynn Regional Cancer Center West
🇺🇸Boca Raton, Florida, United States
Cedars-Sinai Outpatient Cancer Center
🇺🇸Los Angeles, California, United States
Desert Regional Medical Center Comprehensive Cancer Center
🇺🇸Palm Springs, California, United States
John H. Stroger, Jr. Hospital of Cook County
🇺🇸Chicago, Illinois, United States
Maimonides Cancer Center
🇺🇸Brooklyn, New York, United States
St Vincent Comprehensive Cancer Center
🇺🇸New York City, New York, United States
Roswell Park Cancer Institute
🇺🇸Buffalo, New York, United States