Clinical trial NCT00671476: Doxorubicin Hydrochloride Liposome in Treating Women With Ductal Carcinoma in Situ Undergoing Surgery
Official title: Intraductal Therapy of DCIS: A Presurgery Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Breast Cancer
Keywords: ductal breast carcinoma in situ
Lead sponsor: National Cancer Institute (NCI)
Sponsor class: NIH
First posted: 2008-05-05
Enrollment: 30
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Efficacy
measure: Safety
measure: Ability to identify and cannulate the duct
measure: Integration of the Humboldt Community Breast Health Project into the planning and execution of this study
Secondary outcomes:
Other outcomes:
Locations:
city: Eureka
country: United States
facility: St. Joseph Hospital
state: California
city: Santa Monica
country: United States
facility: Doctor Susan Love Research Foundation
state: California
Study officials:
affiliation: Dr. Susan Love Research Foundation
name: Susan Love, MD, MBA
role: PRINCIPAL_INVESTIGATOR
References: