Doxorubicin Hydrochloride Liposome in Treating Women With Ductal Carcinoma in Situ Undergoing Surgery
| Status: | Recruiting |
|---|---|
| Conditions: | Breast Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/2/2016 |
| Start Date: | February 2008 |
Intraductal Therapy of DCIS: A Presurgery Study
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.
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.
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.
- 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.
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
We found this trial at
2
sites
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