Breast Cancer
Conditions
Keywords
ductal breast carcinoma in situ
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.
Interventions
DRUGpegylated liposomal doxorubicin hydrochloride
GENETICDNA methylation analysis
GENETICfluorescence in situ hybridization
GENETICpolymerase chain reaction
OTHERimmunoenzyme technique
OTHERimmunohistochemistry staining method
OTHERlaboratory biomarker analysis
PROCEDUREbreast duct lavage
PROCEDUREneoadjuvant therapy
PROCEDUREtherapeutic conventional surgery
Sponsors
Dr. Susan Love Research Foundation
Study design
Allocation
RANDOMIZED
Primary purpose
TREATMENT
Masking
SINGLE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
DISEASE CHARACTERISTICS: * Diagnosis of ductal breast carcinoma in situ by core needle biopsy * No pathological invasive or microinvasive disease in the affected breast * Mammographic microcalcifications are limited to one ductal system or one quadrant of breast * Hormone receptor status not specified PATIENT CHARACTERISTICS: * Menopausal status not specified * Must be able to undergo necessary surgery * Not pregnant PRIOR CONCURRENT THERAPY: * No prior surgery or radiotherapy to the recently diagnosed breast * More than 12 months since prior chemotherapy * No prior subareolar breast surgery to the affected breast * Not concurrently involved in a research protocol for unapproved new drug evaluation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Efficacy | — |
| Safety | — |
| Ability to identify and cannulate the duct | — |
| Integration of the Humboldt Community Breast Health Project into the planning and execution of this study | — |
Countries
United States
Outcome results
None listed