Atypical Ductal Breast HyperplasiaPhase 1NCT01372644
Breast Cancer Chemoprevention by SOM230, an IGF-I Action Inhibitor: A Proof of Principle Trial
A Phase 1 study testing SOM 230 / Pasireotide in people with Atypical Ductal Breast Hyperplasia and Lobular Carcinoma in Situ (LCIS), run by NYU Langone Health at 1 site in United States.
Trial summary
Atypical ductal hyperplasia (ADH) and atypical lobular hyperplasia (ALH) increases breast cancer risk. In post menopausal women, SERMS are standard chemopreventive agents. The investigators have previously shown insulin-like growth factor-I (IGF-I) is required to permit estrogen (E2) and progesterone action in the… Read more about this study
- Who is it for?
- Ages 21 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Atypical Ductal Breast Hyperplasia, Lobular Carcinoma in Situ (LCIS), Atypical Lobular Hyperplasia (ALH) of Breast
- What is being tested?
- SOM 230 / Pasireotide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2007to Nov 2013
- Phase
- Phase 1
- 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 21 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Over 21 years of age
- Must sign informed consent, witnessed, and dated prior to entry
- The participant has an increased risk for developing breast cancer which may include; Atypical Ductal Hyperplasia (ADH), Lobular Carcinoma in situ (LCIS), and/or Atypical Lobular Hyperplasia (ALH)
- Performance Status: ECOG 0-1 unless mobility is limited from chronic physical handicap
- No clinical evidence of other malignancies (except Basal Cell carcinoma)
- Complete blood count, differential and platelet count must be within normal limits (WNL) or verified by the study chair to be related to conditions not interfering with normal health status
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- Adequate hepatic and renal function (these must be WNL or verified by study chair to be related to conditions not interfering with normal health status)
- Normal fasting glucose
- No history of diabetes
- Medically and Psychologically able to comply with all study requirements
- Accessible to Follow up
Who cannot join
- Less than 21 years of age
- Known invasive breast cancer of any type
- Bilateral prophylactic mastectomy
- Prior malignancy of any type that occurred less than 5 years previously, except for basal or squamous cell carcinoma of the skin or carcinoma in situ of the cervix
- Existing non-malignant disease that would preclude the administration of SOM230
- Pregnancy: All subjects will have a beta human chorionic gonadotropin (b-hCG) serum pregnancy test to rule out pregnancy, a history will also be taken to make certain that recent sexual exposure does not put them at risk for pregnancy. If so a second serum pregnancy test will be done. Volunteers will be asked to use barrier contraception during study.
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- Tamoxifen or other preventive measures within 6 months
- Serious Psychiatric condition or addictive disorder
- Diabetes or elevated fasting blood sugar
- Inability to inject medication or test for finger stick glucose
- Symptomatic gallstones or known gall bladder disease
- History of cholecystitis without cholecystectomy
- Electrolyte abnormalities (particularly hypokalemia or hypomagnesemia)
- QT related exclusion criteria
- QTcF at screening > 450 msec.
- History of syncope or family history of idiopathic sudden death.
- Sustained or clinically significant cardiac arrhythmias.
- Risk factors for Torsades de Pointes such as hypokalemia, hypomagnesemia, cardiac failure, clinically significant/symptomatic bradycardia, or high-grade AV block.
- Concomitant disease(s) that could prolong QT such as autonomic neuropathy (caused by diabetes, or Parkinson's disease), HIV, cirrhosis, uncontrolled hypothyroidism or cardiac failure
- Concomitant medication(s) known to increase the QT interval.
Trial locations and contacts
1 site in 1 country.
About this study
Atypical ductal hyperplasia (ADH) and atypical lobular hyperplasia (ALH) increases breast cancer risk. In post menopausal women, SERMS are standard chemopreventive agents. The investigators have previously shown insulin-like growth factor-I (IGF-I) is required to permit estrogen (E2) and progesterone action in the mammary gland, and that a novel somatostatin analog, SOM230, that inhibits IGF-I action can prevent E2 action on the mammary gland. It reduces cell proliferation and increases apoptosis (cell death) in the rat mammary gland. This study was designed to determine whether women at high risk for breast cancer respond to SOM230 in the same way that rats do. Methods: Women with atypical ductal hyperplasia or lobular carcinoma in-situ by core biopsy were treated for 9.5 days with SOM230 (600mcg BID). Surgical excision was performed on day 10. Sections were examined before and after SOM230 treatment for cell proliferation (Ki67) and apoptosis (TUNEL). Serum IGF-I, fasting glucose, insulin, and HbA1C were measured in anticipation of changes.
- Conditions
- Atypical Ductal Breast Hyperplasia, Lobular Carcinoma in Situ (LCIS), Atypical Lobular Hyperplasia (ALH) of Breast
- Being tested
- SOM 230 / Pasireotide
- Medical subject headings
- Carcinoma, Intraductal, Noninfiltrating, Breast Carcinoma In Situ
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SOM 230 / PasireotideDrug
| Study group | Role | What they receive |
|---|---|---|
| ADH, ALH, LCIS, SOM 230 | Experimental | Women who meet eligibility criteria. Receives: Drug: SOM 230 / Pasireotide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cell Proliferation and apoptosis
Tissue from initial diagnostic breast biopsies will be compared to the remaining tissue excised after treatment with SOM230. Tissue will be stained to measure cell proliferation and apoptosis (cell death).
Measured: 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2011 (estimated)
- Study startNov 2007
- Primary completionDec 2010
- Study completionNov 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Atypical Ductal Breast HyperplasiaStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe 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
- Interventional
- Phase
- Phase 1
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Collaborators
- United States Department of Defense
- Responsible party
- Sponsor
- Investigators
- David L Kleinberg, MD, Principal investigator, NYU School of MedicineJulia Smith, MD, Study director, NYU School of MedicineDeborah Axelrod, MD, Study director, NYU School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01372644
- Sponsor's protocol ID
- R6-937
- Other IDs
- BC061512
- Status last verified
- Dec 2016
- First submitted
- 9 Jun 2011
- Last updated
- 5 Dec 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
Singh B, Smith JA, Axelrod DM, Ameri P, Levitt H, Danoff A, Lesser M, de Angelis C, Illa-Bochaca I, Lubitz S, Huberman D, Darvishian F, Kleinberg DL. Insulin-like growth factor-I inhibition with pasireotide decreases cell proliferation and increases apoptosis in pre-malignant lesions of the breast: a phase 1 proof of principle trial. Breast Cancer Res. 2014 Nov 11;16(6):463. doi: 10.1186/s13058-014-0463-1.
PubMed 25385439
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Breast Cancer Chemoprevention by SOM230, an IGF-I Action Inhibitor: A Proof of Principle Trial
- ClinicalTrials.gov ID
- NCT01372644
- Acronym / sponsor ID
- R6-937
- Conditions
- Atypical Ductal Breast Hyperplasia, Lobular Carcinoma in Situ (LCIS), Atypical Lobular Hyperplasia (ALH) of Breast
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Collaborators
- United States Department of Defense
- Study start
- Nov 2007
- Primary completion
- Dec 2010 (actual)
- Study completion
- Nov 2013 (actual)
- First posted
- 14 Jun 2011 (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.
Atypical ductal hyperplasia (ADH) and atypical lobular hyperplasia (ALH) increases breast cancer risk. In post menopausal women, SERMS are standard chemopreventive agents. The investigators have previously shown insulin-like growth factor-I (IGF-I) is required to permit estrogen (E2) and progesterone action in the mammary gland, and that a novel somatostatin analog, SOM230, that inhibits IGF-I action can prevent E2 action on the mammary gland. It reduces cell proliferation and increases apoptosis (cell death) in the rat mammary gland. This study was designed to determine whether women at high risk for breast cancer respond to SOM230 in the same way that rats do. Methods: Women with atypical ductal hyperplasia or lobular carcinoma in-situ by core biopsy were treated for 9.5 days with SOM230 (600mcg BID). Surgical excision was performed on day 10. Sections were examined before and after SOM230 treatment for cell proliferation (Ki67) and apoptosis (TUNEL). Serum IGF-I, fasting glucose, insulin, and HbA1C were measured in anticipation of changes.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ADH, ALH, LCIS, SOM 230 | Experimental | Drug: SOM 230 / PasireotideWomen who meet eligibility criteria. |
Who may qualify
- Ages
- 21 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Over 21 years of age
- Must sign informed consent, witnessed, and dated prior to entry
- The participant has an increased risk for developing breast cancer which may include; Atypical Ductal Hyperplasia (ADH), Lobular Carcinoma in situ (LCIS), and/or Atypical Lobular Hyperplasia (ALH)
- Performance Status: ECOG 0-1 unless mobility is limited from chronic physical handicap
- No clinical evidence of other malignancies (except Basal Cell carcinoma)
Key exclusion criteria (20 listed)
- Less than 21 years of age
- Known invasive breast cancer of any type
- Bilateral prophylactic mastectomy
- Prior malignancy of any type that occurred less than 5 years previously, except for basal or squamous cell carcinoma of the skin or carcinoma in situ of the cervix
- Existing non-malignant disease that would preclude the administration of SOM230
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 |
|---|---|---|
| SOM 230 / Pasireotide | Drug | ADH, ALH, LCIS, SOM 230 |
Primary outcome
Cell Proliferation and apoptosis
Time frame: 10 days
Tissue from initial diagnostic breast biopsies will be compared to the remaining tissue excised after treatment with SOM230. Tissue will be stained to measure cell proliferation and apoptosis (cell death).
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 5 Dec 2016.
- Derived from this study: PubMed 25385439Singh B, Smith JA, Axelrod DM, Ameri P, Levitt H, Danoff A, Lesser M, de Angelis C, Illa-Bochaca I, Lubitz S, Huberman D, Darvishian F, Kleinberg DL. Insulin-like growth factor-I inhibition with pasireotide decreases cell proliferation and increases apoptosis in pre-malignant lesions of the breast: a phase 1 proof of principle trial. Breast Cancer Res. 2014 Nov 11;16(6):463. doi: 10.1186/s13058-014-0463-1.
- Individual participant dataSharing planned: Undecided
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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.
David L Kleinberg, MD principal investigator
NYU School of Medicine
Julia Smith, MD study director
NYU School of Medicine
Deborah Axelrod, MD study director
NYU School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing SOM 230 / Pasireotide in people with Atypical Ductal Breast Hyperplasia and Lobular Carcinoma in Situ (LCIS), run by NYU Langone Health at 1 site 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 11 inclusion and 20 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 5 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Cell Proliferation and apoptosis (time frame: 10 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01372644, which also lists 1 linked publication.
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 5 Dec 2016.