Phase II Study in Patients With Operable Breast Cancer
Status unconfirmed · Phase 2
Conditions studied: Breast Cancer
In brief
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.
Key facts
- Study ID
- NCT00518583
- Run by
- Aptium Oncology Research Network
- People needed
- 30
- Starts
- 2006-10-01
- Expected to finish
- 2009-09-01
- Last updated by the study team
- 2010-01-15
Who can join
Age: 21 and older. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Providence St. Joseph Medical Hospital — Burbank, California, United States
- Cedars-Sinai Outpatient Cancer Center — Los Angeles, California, United States
- Desert Regional Medical Center Comprehensive Cancer Center — Palm Springs, California, United States
- Lynn Regional Cancer Center West — Boca Raton, Florida, United States
- John H. Stroger, Jr. Hospital of Cook County — Chicago, Illinois, United States
- Maimonides Cancer Center — Brooklyn, New York, United States
- Roswell Park Cancer Institute — Buffalo, New York, United States
- St Vincent Comprehensive Cancer Center — New York, New York, United States
- University of Cincinnati — Cincinnati, Ohio, United States
Full record on ClinicalTrials.gov
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