Breast CancerPhase 2NCT00416403
Effect of Fluvastatin on Biomarkers in Women Who Are Undergoing Surgery for Ductal Carcinoma In Situ or Stage I Breast Cancer
A Phase 2 study testing fluvastatin sodium and Breast Cancer Surgery Only - Arm III in people with Breast Cancer, run by University of California, San Francisco at 4 sites in United States.
Trial summary
RATIONALE: Collecting samples of blood and tissue from patients with cancer to study in the laboratory may help doctors learn how fluvastatin effects biomarkers related to breast cancer. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- fluvastatin sodium and Breast Cancer Surgery Only - Arm III
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 4 sitesUnited States
- Study dates
- Jul 2006to Jun 2011
- Phase
- Phase 2
- 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
DISEASE CHARACTERISTICS:
- Histologically confirmed ductal carcinoma in situ (DCIS) or stage I breast cancer by stereotactic core or incisional biopsy
- Planning to undergo surgery in 3-6 weeks
- Patients undergoing re-excision due to evidence of tumor present at surgical margins are eligible
- Hormone receptor status not specified
PATIENT CHARACTERISTICS:
- Female
- Menopausal status not specified
- ALT and AST ≤ 10% above upper limit of normal
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- Able to tolerate statins
- Willing to undergo 2 blood draws (separated by approximately 3-4 weeks) during study participation (control arm)
PRIOR CONCURRENT THERAPY:
- No other concurrent statins
- No concurrent chemotherapy
- No concurrent administration of any of the following:
- Niacin
- Propranolol
- Cholestyramine
- Cyclosporine
- Digoxin
- Erythromycin
- Itraconazole
- Gemfibrozil
- Phenytoin
- Diclofenac
- Tolbutamide
- Glyburide
- Losartan
- Cimetidine
- Ranitidine
- Omeprazole
- Rifampin
- Warfarin
- No initiation of new hormonal therapy during study participation
- Concurrent participation in other clinical trials (e.g., for DCIS or prevention) is allowed
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Dana-Farber/Harvard Cancer Center at Dana-Farber Cancer Institute
Boston, Massachusetts, 02115-6084
University of Chicago Cancer Research Center
Chicago, Illinois, 60637-1470
Memorial Sloan-Kettering Cancer Center
New York, New York, 10065
UCSF Helen Diller Family Comprehensive Cancer Center
San Francisco, California, 94115
About this study
Official title: Randomized Phase II Biomarker Pilot Trial of Fluvastatin Use in Women With Ductal Carcinoma in Situ (DCIS) or Stage I Breast Cancer
RATIONALE: Collecting samples of blood and tissue from patients with cancer to study in the laboratory may help doctors learn how fluvastatin effects biomarkers related to breast cancer.
PURPOSE: This randomized phase II trial is studying how fluvastatin effects biomarkers in women undergoing surgery for ductal carcinoma in situ or stage I breast cancer.
Read the detailed description
OBJECTIVES:
Primary
- Determine differences between measures of cell proliferation (Ki-67) in women with ductal carcinoma in situ (DCIS) or stage I breast cancer receiving neoadjuvant fluvastatin sodium.
Secondary
- Determine whether statin use differentially affects specific types of DCIS/early-stage breast cancer (comedo, estrogen receptor [ER]-positive, ER-negative).
- Compare differences between tissue staining of CD68, circulating macrophages, and regulatory T cells in these patients.
- Assess the feasibility of using inherent susceptibility (mRNA polymerase chain reaction testing) to predict response to statins in these patients.
OUTLINE: This is a randomized, controlled, single-blind, multicenter, pilot study. Patients are randomized to 1 of 2 treatment arms (arms I or II). Patients accrued as control participants are assigned to arm III.
- Arm I: Patients receive oral fluvastatin sodium once daily for 3-6 weeks in the absence of disease progression or unacceptable toxicity.
- Arm II: Patients receive oral fluvastatin sodium as in arm I at a higher dose.
- Arm III (control): Patients do not receive fluvastatin sodium. All patients then undergo definitive surgery.
Patients in arms I and II undergo blood collection at baseline and at the time of surgery for biomarker analysis. Patients in arm III undergo blood collection at baseline and then approximately 1 month later. Tissue is collected from patients in all arms at the time of surgery. Blood and tissue samples are examined for biological markers, including Ki-67, C-reactive protein, cleaved caspase 3, HER2, CD68 gene, and estrogen and progesterone receptors by immunohistochemistry. Markers of inflammation (e.g., comedo necrosis macrophages and CD25-positive T cells), low-density lipoprotein, and cholesterol are also analyzed. Serum mRNA is measured by polymerase chain reaction.
PROJECTED ACCRUAL: A total of 60 patients will be accrued for this study.
- Conditions
- Breast Cancer
- Being tested
- fluvastatin sodium, Breast Cancer Surgery Only - Arm III
- Keywords
- breast cancer in situ, ductal breast carcinoma in situ, stage IA breast cancer, stage IB breast cancer
- Medical subject headings
- Breast Neoplasms, Breast Carcinoma In Situ, Carcinoma, Intraductal, Noninfiltrating
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fluvastatin sodiumDrug
Given orally
Breast Cancer Surgery Only - Arm IIIProcedure or surgery
Breast Cancer Surgery
| Study group | Role | What they receive |
|---|---|---|
| Arm I | Experimental | Patients receive oral fluvastatin sodium once daily for 3-6 weeks in the absence of disease progression or unacceptable toxicity. Receives: Drug: fluvastatin sodium |
| Arm II | Experimental | Patients receive oral fluvastatin sodium as in arm I at a higher dose. Receives: Drug: fluvastatin sodium |
| Arm III | Experimental | Patients do not receive fluvastatin sodium. breast Cancer surgery only Receives: Procedure: Breast Cancer Surgery Only - Arm III |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in proliferation after statin exposure, as measured by Ki-67 level
Measured: up to 6 weeks
Secondary outcomes (3)
Blood and serum markers, including C-reactive protein, cleaved caspase 3, HER2, CD68, macrophages and immunoregulatory CD25 T cells, estrogen and progesterone receptors, mRNA, low-density lipoprotein, and cholesterol
Measured: up to 6 weeks
Presence of comedo necrosis
Measured: up to 6 weeks
Safety
Measured: up to 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2006 (estimated)
- Study startJul 2006
- Primary completionSep 2007
- Study completionJun 2011
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 Breast CancerStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Laura J. Esserman, MD, MBA, Study chair, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00416403
- Sponsor's protocol ID
- CDR0000522934
- Other IDs
- UCSF-047522, UCSF-H8409-26206-01, MSKCC-06041
- Status last verified
- Dec 2012
- First submitted
- 27 Dec 2006
- Last updated
- 13 Dec 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Garwood ER, Kumar AS, Baehner FL, Moore DH, Au A, Hylton N, Flowers CI, Garber J, Lesnikoski BA, Hwang ES, Olopade O, Port ER, Campbell M, Esserman LJ. Fluvastatin reduces proliferation and increases apoptosis in women with high grade breast cancer. Breast Cancer Res Treat. 2010 Jan;119(1):137-44. doi: 10.1007/s10549-009-0507-x.
PubMed 19728082
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Phase II Biomarker Pilot Trial of Fluvastatin Use in Women With Ductal Carcinoma in Situ (DCIS) or Stage I Breast Cancer
- ClinicalTrials.gov ID
- NCT00416403
- Acronym / sponsor ID
- CDR0000522934
- Conditions
- Breast Cancer
- Keywords
- breast cancer in situ, ductal breast carcinoma in situ, stage IA breast cancer, stage IB breast cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Jul 2006
- Primary completion
- Sep 2007 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 28 Dec 2006 (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: Collecting samples of blood and tissue from patients with cancer to study in the laboratory may help doctors learn how fluvastatin effects biomarkers related to breast cancer.
PURPOSE: This randomized phase II trial is studying how fluvastatin effects biomarkers in women undergoing surgery for ductal carcinoma in situ or stage I breast cancer.
Detailed description
OBJECTIVES:
Primary
- Determine differences between measures of cell proliferation (Ki-67) in women with ductal carcinoma in situ (DCIS) or stage I breast cancer receiving neoadjuvant fluvastatin sodium.
Secondary
- Determine whether statin use differentially affects specific types of DCIS/early-stage breast cancer (comedo, estrogen receptor [ER]-positive, ER-negative).
- Compare differences between tissue staining of CD68, circulating macrophages, and regulatory T cells in these patients.
- Assess the feasibility of using inherent susceptibility (mRNA polymerase chain reaction testing) to predict response to statins in these patients.
OUTLINE: This is a randomized, controlled, single-blind, multicenter, pilot study. Patients are randomized to 1 of 2 treatment arms (arms I or II). Patients accrued as control participants are assigned to arm III.
- Arm I: Patients receive oral fluvastatin sodium once daily for 3-6 weeks in the absence of disease progression or unacceptable toxicity.
- Arm II: Patients receive oral fluvastatin sodium as in arm I at a higher dose.
- Arm III (control): Patients do not receive fluvastatin sodium. All patients then undergo definitive surgery.
Patients in arms I and II undergo blood collection at baseline and at the time of surgery for biomarker analysis. Patients in arm III undergo blood collection at baseline and then approximately 1 month later. Tissue is collected from patients in all arms at the time of surgery. Blood and tissue samples are examined for biological markers, including Ki-67, C-reactive protein, cleaved caspase 3, HER2, CD68 gene, and estrogen and progesterone receptors by immunohistochemistry. Markers of inflammation (e.g., comedo necrosis macrophages and CD25-positive T cells), low-density lipoprotein, and cholesterol are also analyzed. Serum mRNA is measured by polymerase chain reaction.
PROJECTED ACCRUAL: A total of 60 patients will be accrued for this study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Arm I | Experimental | Drug: fluvastatin sodiumPatients receive oral fluvastatin sodium once daily for 3-6 weeks in the absence of disease progression or unacceptable toxicity. |
| Arm II | Experimental | Drug: fluvastatin sodiumPatients receive oral fluvastatin sodium as in arm I at a higher dose. |
| Arm III | Experimental | Procedure: Breast Cancer Surgery Only - Arm IIIPatients do not receive fluvastatin sodium. breast Cancer surgery only |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, 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 |
|---|---|---|
| fluvastatin sodiumGiven orally | Drug | Arm I, Arm II |
| Breast Cancer Surgery Only - Arm IIIBreast Cancer Surgery | Procedure or surgery | Arm III |
Primary outcome
Change in proliferation after statin exposure, as measured by Ki-67 level
Time frame: up to 6 weeks
3 secondary outcomes
Blood and serum markers, including C-reactive protein, cleaved caspase 3, HER2, CD68, macrophages and immunoregulatory CD25 T cells, estrogen and progesterone receptors, mRNA, low-density lipoprotein, and cholesterol
Time frame: up to 6 weeks
Presence of comedo necrosis
Time frame: up to 6 weeks
Safety
Time frame: up to 6 weeks
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 13 Dec 2012.
- Results publication: PubMed 19728082Garwood ER, Kumar AS, Baehner FL, Moore DH, Au A, Hylton N, Flowers CI, Garber J, Lesnikoski BA, Hwang ES, Olopade O, Port ER, Campbell M, Esserman LJ. Fluvastatin reduces proliferation and increases apoptosis in women with high grade breast cancer. Breast Cancer Res Treat. 2010 Jan;119(1):137-44. doi: 10.1007/s10549-009-0507-x.
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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.
Laura J. Esserman, MD, MBA study chair
University of California, San Francisco
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing fluvastatin sodium and Breast Cancer Surgery Only - Arm III in people with Breast Cancer, run by University of California, San Francisco at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Dec 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Change in proliferation after statin exposure, as measured by Ki-67 level (time frame: up to 6 weeks). 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 NCT00416403, 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 13 Dec 2012.