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Intraductal Therapy of DCIS: A Presurgery Study


N/A
18 Years
N/A
Open (Enrolling)
Female
Breast Cancer

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Trial Information

Intraductal Therapy of DCIS: A Presurgery Study


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.

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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Masking: Single Blind, Primary Purpose: Treatment

Outcome Measure:

Efficacy

Safety Issue:

No

Principal Investigator

Susan Love, MD, MBA

Investigator Role:

Principal Investigator

Investigator Affiliation:

Doctor Susan Love Research Foundation

Authority:

Unspecified

Study ID:

CDR0000594671

NCT ID:

NCT00671476

Start Date:

February 2008

Completion Date:

Related Keywords:

  • Breast Cancer
  • ductal breast carcinoma in situ
  • Breast Neoplasms
  • Carcinoma in Situ
  • Carcinoma, Intraductal, Noninfiltrating

Name

Location

St. Joseph HospitalOrange, California  92868
Doctor Susan Love Research FoundationSanta Monica, California  90403