Breast NeoplasmsNCT00146536
Upstaging of ALH/LCIS Found on Core Biopsy Based on Subsequent Excisional Biopsy
An observational study of Breast Neoplasms, run by Dana-Farber Cancer Institute at 2 sites in United States.
Trial summary
The goal of this study is to determine how often patients who have atypical lobular hyperplasia (ALH) or lobular carcinoma in situ (LCIS) on core needle biopsy of an imaging (found by mammogram or breast ultrasound) abnormality will have associated breast cancer at surgical removal of the area. Read more about this study
- Who is it for?
- Ages 20 years and older, women only
- Conditions the study is for
- Breast Neoplasms
- How many people
- 78 participants
- Where
- 2 sitesUnited States
- Study dates
- Nov 2004to Nov 2012
- Phase
- Observational
- 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 20 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Individuals who have ALH/LCIS detected on a needle biospy of the breast
Who may be able to join
- Women 20 years of age or older
- Imaging abnormality necessitating a core needle biopsy
- Core needle biopsy revealing ALH or LCIS
- Patients may have a history of fibroadenoma and/or proliferative breast lesions with atypia
Who cannot join
- History and/or concomitant diagnosis of invasive breast cancer or ductal carcinoma in situ (DCIS)
- A palpable abnormality diagnosed by core needle biopsy to be ALH or LCIS
- Received tamoxifen in the past
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Dana-Farber Cancer Center
Boston, Massachusetts, 02115
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
About this study
Official title: The Incidence of Adjacent Synchronous Ipsilateral Infiltrating Carcinoma, DCIS, or Atypical Ductal Hyperplasia (ADH) in Patients Diagnosed With Lobular Neoplasia of the Breast by Core Needle Biopsy
The goal of this study is to determine how often patients who have atypical lobular hyperplasia (ALH) or lobular carcinoma in situ (LCIS) on core needle biopsy of an imaging (found by mammogram or breast ultrasound) abnormality will have associated breast cancer at surgical removal of the area.
Read the detailed description
Patients will undergo a breast biopsy at which the area found to be ALH or LCIS on core biopsy will be removed surgically through a small incision in the breast.
- The surgical biopsy specimen will be carefully examined by a pathologist, and may be useful in guiding further therapy if needed.
- In the future, tissue from the surgical biopsy may be used to study genetic changes that may be responsible for cancer formation and prevention. The tissue will be kept for future research for up to 10 years.
- Conditions
- Breast Neoplasms
- Keywords
- ALH, LCIS, DCIS, adjacent ipsilateral infiltrating carcinoma, core needle biopsy, Lobular neoplasia of the breast
- Medical subject headings
- Breast Neoplasms, Carcinoma, Intraductal, Noninfiltrating
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of upstaging from Lobular Neoplasia on core biopsy to invasive breast cancer or ductal carcinoma in situ on excisional biopsy
Measured: Concomittant
Secondary outcomes (1)
Factors which predict for upstaging from Lobular Neoplasia on core biopsy to invasive breast carcinoma or ductal carcinoma in situ
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2005 (estimated)
- Study startNov 2004
- Primary completionNov 2012
- Study completionNov 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast NeoplasmsStudies of the same condition, open and under way.
- More trials run by Dana-Farber Cancer InstituteThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 78 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dana-Farber Cancer Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Translational Breast Cancer Research Consortium, Beth Israel Deaconess Medical Center, Brigham and Women's Hospital
- Responsible party
- Principal investigator, Faina Nakhlis, MD, Dana-Farber Cancer Institute
- Investigators
- Faina Nakhlis, MD, Principal investigator, Dana-Farber Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00146536
- Sponsor's protocol ID
- 04-164
- Status last verified
- Nov 2012
- First submitted
- 2 Sep 2005
- Last updated
- 31 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Incidence of Adjacent Synchronous Ipsilateral Infiltrating Carcinoma, DCIS, or Atypical Ductal Hyperplasia (ADH) in Patients Diagnosed With Lobular Neoplasia of the Breast by Core Needle Biopsy
- ClinicalTrials.gov ID
- NCT00146536
- Acronym / sponsor ID
- 04-164
- Conditions
- Breast Neoplasms
- Keywords
- ALH, LCIS, DCIS, adjacent ipsilateral infiltrating carcinoma, core needle biopsy, Lobular neoplasia of the breast
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 78 participants (estimated)
- Lead sponsor
- Dana-Farber Cancer InstituteUniversity, hospital or other
- Collaborators
- Translational Breast Cancer Research Consortium, Beth Israel Deaconess Medical Center, Brigham and Women's Hospital
- Study start
- Nov 2004
- Primary completion
- Nov 2012 (actual)
- Study completion
- Nov 2012 (actual)
- First posted
- 7 Sep 2005 (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.
The goal of this study is to determine how often patients who have atypical lobular hyperplasia (ALH) or lobular carcinoma in situ (LCIS) on core needle biopsy of an imaging (found by mammogram or breast ultrasound) abnormality will have associated breast cancer at surgical removal of the area.
Detailed description
Patients will undergo a breast biopsy at which the area found to be ALH or LCIS on core biopsy will be removed surgically through a small incision in the breast.
- The surgical biopsy specimen will be carefully examined by a pathologist, and may be useful in guiding further therapy if needed.
- In the future, tissue from the surgical biopsy may be used to study genetic changes that may be responsible for cancer formation and prevention. The tissue will be kept for future research for up to 10 years.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 20 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Individuals who have ALH/LCIS detected on a needle biospy of the breast
Key inclusion criteria (4 listed)
- Women 20 years of age or older
- Imaging abnormality necessitating a core needle biopsy
- Core needle biopsy revealing ALH or LCIS
- Patients may have a history of fibroadenoma and/or proliferative breast lesions with atypia
Key exclusion criteria (3 listed)
- History and/or concomitant diagnosis of invasive breast cancer or ductal carcinoma in situ (DCIS)
- A palpable abnormality diagnosed by core needle biopsy to be ALH or LCIS
- Received tamoxifen in the past
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Rate of upstaging from Lobular Neoplasia on core biopsy to invasive breast cancer or ductal carcinoma in situ on excisional biopsy
Time frame: Concomittant
1 secondary outcome
Factors which predict for upstaging from Lobular Neoplasia on core biopsy to invasive breast carcinoma or ductal carcinoma in situ
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2017.
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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.
Faina Nakhlis, MD principal investigator
Dana-Farber Cancer Institute
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Neoplasms, run by Dana-Farber Cancer Institute 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?
The sponsor lists 4 inclusion and 3 exclusion criteria. 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: finished, as of the sponsor's last update on 31 Mar 2017. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of upstaging from Lobular Neoplasia on core biopsy to invasive breast cancer or ductal carcinoma in situ on excisional biopsy (time frame: Concomittant). 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 31 Mar 2017.