Breast CancerNCT00671476
Doxorubicin Hydrochloride Liposome in Treating Women With Ductal Carcinoma in Situ Undergoing Surgery
A study testing pegylated liposomal doxorubicin hydrochloride, DNA methylation analysis and TdT-mediated dUTP nick end labeling assay in people with Breast Cancer, run by Dr. Susan Love Research Foundation at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- pegylated liposomal doxorubicin hydrochloride, DNA methylation analysis and TdT-mediated dUTP nick end labeling assay
- Type of treatment
- Surgery or procedure
- How many people
- 30 participants
- Where
- 2 sitesUnited States
- Study dates
- Feb 2008to Feb 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
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
Trial locations and contacts
2 sites in 1 country.
United States2 sites, 2 recruiting
- Recruiting
St. Joseph Hospital
Eureka, California, 95501
M. Ellen Mahoney, MD, 707-445-8121
- Recruiting
Doctor Susan Love Research Foundation
Santa Monica, California, 90403
Susan Love, MD, MBA, 866-569-0388, info@dslrf.org
About this study
Official title: 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.
Read the 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.
- Conditions
- Breast Cancer
- Being tested
- pegylated liposomal doxorubicin hydrochloride, DNA methylation analysis, TdT-mediated dUTP nick end labeling assay, fluorescence in situ hybridization, loss of heterozygosity analysis
- Keywords
- ductal breast carcinoma in situ
- Medical subject headings
- Breast Neoplasms, Carcinoma, Intraductal, Noninfiltrating
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pegylated liposomal doxorubicin hydrochlorideDrug
DNA methylation analysisGenetic
TdT-mediated dUTP nick end labeling assayGenetic
fluorescence in situ hybridizationGenetic
loss of heterozygosity analysisGenetic
polymerase chain reactionGenetic
immunoenzyme techniqueOther
laboratory biomarker analysisOther
breast duct lavageProcedure or surgery
neoadjuvant therapyProcedure or surgery
therapeutic conventional surgeryProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2008 (estimated)
- Study startFeb 2008
- Primary completionFeb 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Masking
- Single blind
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dr. Susan Love Research Foundation
- Sponsor type
- University, hospital or other
- Investigators
- Susan Love, MD, MBA, Principal investigator, Dr. Susan Love Research Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00671476
- Sponsor's protocol ID
- CDR0000594671
- Other IDs
- DSLRF-SJHCA-00003154, SJHCA-00003154
- Status last verified
- Jun 2009
- First submitted
- 2 May 2008
- Last updated
- 10 Jan 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intraductal Therapy of DCIS: A Presurgery Study
- ClinicalTrials.gov ID
- NCT00671476
- Acronym / sponsor ID
- CDR0000594671
- Conditions
- Breast Cancer
- Keywords
- ductal breast carcinoma in situ
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Dr. Susan Love Research FoundationUniversity, hospital or other
- Study start
- Feb 2008
- Primary completion
- Feb 2011 (estimated)
- First posted
- 5 May 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Masking
- Single blind
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| pegylated liposomal doxorubicin hydrochloride | Drug | – |
| DNA methylation analysis | Genetic | – |
| TdT-mediated dUTP nick end labeling assay | Genetic | – |
| fluorescence in situ hybridization | Genetic | – |
| loss of heterozygosity analysis | Genetic | – |
| polymerase chain reaction | Genetic | – |
| immunoenzyme technique | Other | – |
| immunohistochemistry staining method | Other | – |
| laboratory biomarker analysis | Other | – |
| breast duct lavage | Procedure or surgery | – |
| neoadjuvant therapy | Procedure or surgery | – |
| therapeutic conventional surgery | Procedure or surgery | – |
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Susan Love, MD, MBA principal investigator
Dr. Susan Love Research Foundation
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing pegylated liposomal doxorubicin hydrochloride, DNA methylation analysis and TdT-mediated dUTP nick end labeling assay in people with Breast Cancer, run by Dr. Susan Love Research Foundation at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy. The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jan 2014.