Doxorubicin Hydrochloride Liposome in Treating Women With Ductal Carcinoma in Situ Undergoing Surgery

Dr. Susan Love Research Foundation

Status: Unknown

Conditions: Breast Cancer

Treatments: Genetic: polymerase chain reaction; Genetic: fluorescence in situ hybridization; Procedure: therapeutic conventional surgery; Procedure: breast duct lavage; Other: laboratory biomarker analysis; Other: immunoenzyme technique; Genetic: loss of heterozygosity analysis; Other: immunohistochemistry staining method; Drug: pegylated liposomal doxorubicin hydrochloride; Procedure: neoadjuvant therapy; Genetic: TdT-mediated dUTP nick end labeling assay; Genetic: DNA methylation analysis

Study type: Interventional

Funder types: Other

Identifiers

NCT00671476

CDR0000594671

DSLRF-SJHCA-00003154

SJHCA-00003154

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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