Doxorubicin Hydrochloride Liposome in Treating Women With Ductal Carcinoma in Situ Undergoing Surgery
- Conditions
- Breast Cancer
- Registration Number
- NCT00671476
- Lead Sponsor
- Dr. Susan Love Research Foundation
- Brief Summary
RATIONALE: Drugs used in chemotherapy, such as doxorubicin hydrochloride liposome, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving chemotherapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed.
PURPOSE: This clinical trial is studying the side effects of doxorubicin hydrochloride liposome and to see how well it works in treating women with ductal carcinoma in situ undergoing surgery.
- Detailed Description
OBJECTIVES:
* To demonstrate the efficacy and safety of neoadjuvant intraductal pegylated liposomal doxorubicin hydrochloride in women with ductal breast carcinoma in situ undergoing surgery.
* To demonstrate the ability to identify and cannulate the duct demonstrating precancerous disease in these women.
* To integrate the Humboldt Community Breast Health Project into the planning and execution of this study.
OUTLINE: Patients undergo identification of the intraductal lesions via cannulization. Patients receive pegylated liposomal doxorubicin hydrochloride (PLD) intraductally through the inserted cannula. Some patients are randomized to receive saline instead of PLD. Within 4-6 weeks, all patients undergo surgery.
Patients undergo tissue and ductal fluid sample collection at baseline and at surgery for correlative laboratory studies. Tissue samples are assessed for histomorphology, proliferation (Ki67), cell death (apoptosis index), genetic markers, necrosis, inflammation, and loss of heterozygosity by HE stain, IHC, TUNEL, and PCR. Nipple aspirate and ductal lavage fluid samples are analyzed for cytomorphology (cellular atypia), proliferation (Ki67), cell death (TUNEL), differentiation (G-actin), and genetic markers (FISH) by quantitative fluorescence image analysis. Samples are also analyzed for bFGF and CEA by ELISA, and methylation by PCR.
After completion of study therapy, patients are followed every 6 months for at least 2 years.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- Female
- Target Recruitment
- 30
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Ability to identify and cannulate the duct Efficacy Safety Integration of the Humboldt Community Breast Health Project into the planning and execution of this study
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (2)
Doctor Susan Love Research Foundation
🇺🇸Santa Monica, California, United States
St. Joseph Hospital
🇺🇸Eureka, California, United States