Breast CancerPhase 2NCT00354640
Simvastatin and Anastrozole in Treating Postmenopausal Women With Ductal Carcinoma In Situ or Invasive Breast Cancer
A Phase 2 study testing anastrozole, simvastatin and pharmacological study in people with Breast Cancer, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins at 1 site in United States.
Trial summary
RATIONALE: Chemoprevention is the use of certain drugs to keep cancer from forming, growing, or coming back. The use of simvastatin and anastrozole may stop cancer from forming, growing, or coming back in patients with invasive breast cancer, ductal carcinoma in situ, or a high risk of breast cancer. 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?
- anastrozole, simvastatin and pharmacological study
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2006to Nov 2011
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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:
- Meets any of the following criteria:
- History of invasive breast cancer
- History of ductal carcinoma in situ
- At high risk for breast cancer, defined as being on anastrozole for chemoprevention of breast cancer
- Receiving anastrozole for ≥ 30 days as adjuvant breast cancer treatment or for prevention of breast cancer
- No active breast cancer with known metastatic involvement
- Hormone receptor status not specified
PATIENT CHARACTERISTICS:
- Female
- Postmenopausal
- ECOG performance status 0-2
- AST and ALT ≤ 3 times upper limit of normal
- Creatinine clearance ≥ 30 mL/min
- No active liver disease
- No prior hypersensitivity to any HMG-CoA reductase inhibitor or any of its components
- No daily alcohol use of > 3 standard drinks/day
- A standard drink is defined as 10 g of alcohol, which is equivalent to 285 mL of beer, 530 mL of light beer, 100 mL of wine, or 30 mL of liquor
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- No cholesterol-lowering drug, including a statin, within the past 3 months
- No selective estrogen receptor modulator (SERM) within the past 3 months
- No other hormone therapy within the past 3 months
- No prior estrogen and/or progesterone hormone replacement therapy that lasted for ≥ 5 years
- Vaginal estrogen preparations allowed
- No other concurrent statin or cholesterol-lowering drug
- No other concurrent SERM
- No other concurrent hormone therapy
- No other concurrent investigational drugs
- No concurrent CYP3A4 inhibitors, including itraconazole, ketoconazole, erythromycin, clarithromycin, telithromycin, HIV protease inhibitors, nefazodone, or cyclosporine
- No concurrent chemotherapy or biological agents
- No concurrent daily grapefruit juice > 8 oz/day
- No other concurrent anticancer agents or therapies
Trial locations and contacts
1 site in 1 country.
United States1 site
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, 21231-2410
About this study
Official title: A Trial Assessing the Effect of Simvastatin on the Pharmacokinetics of Anastrozole
RATIONALE: Chemoprevention is the use of certain drugs to keep cancer from forming, growing, or coming back. The use of simvastatin and anastrozole may stop cancer from forming, growing, or coming back in patients with invasive breast cancer, ductal carcinoma in situ, or a high risk of breast cancer.
PURPOSE: This phase II trial is studying how well giving simvastatin together with anastrozole works in treating postmenopausal women with invasive breast cancer, ductal carcinoma in situ, or a high risk of breast cancer.
Read the detailed description
OBJECTIVES:
Primary
- Assess the effects of concurrent anastrozole and simvastatin on anastrozole's steady-state concentration in postmenopausal women with history of invasive breast cancer or ductal carcinoma in situ or at high risk for developing breast cancer.
Secondary
- Study the effect of concurrent simvastatin and anastrozole on estrogen suppression in these patients.
OUTLINE: This is a pilot study.
Patients continue to receive oral anastrozole once daily (as prior to study entry). They also receive oral simvastatin once daily for 14-18 days in the absence of unacceptable toxicity or diagnosis of new or recurrent breast cancer.
Patients undergo blood sample collection at baseline and after study therapy for analysis of anastrozole and hormone (estradiol and estrogen) concentrations.
PROJECTED ACCRUAL: A total of 20 patients will be accrued for this study.
- Conditions
- Breast Cancer
- Being tested
- anastrozole, simvastatin, pharmacological study, adjuvant therapy
- Keywords
- breast cancer, breast cancer in situ, ductal breast carcinoma in situ, stage I breast cancer, stage II breast cancer, stage IIIA breast cancer, stage IIIB breast cancer, stage IIIC 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.
anastrozoleDrug
Also called Arimidex
1 milligram tablet PO QD for 14 days
simvastatinDrug
Also called Zocor
40 milligram tablet PO QD for 14 days
laboratory analysis
adjuvant therapyProcedure or surgery
laboratory analysis
| Study group | Role | What they receive |
|---|---|---|
| Anastrozole and Simvastatin | Experimental | This is a pharmacological study for women on anastrozole as adjuvant therapy for breast cancer to receive concurrent simvastatin for up to 14 days. Receives: Drug: anastrozole; Drug: simvastatin; Other: pharmacological study; Procedure: adjuvant therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Blood Concentrations
The change in blood concentrations of anastrozole at baseline and 14 days was measured.
Measured: Baseline and 14 days
Secondary outcomes (1)
Change in Serum Estradiol Levels
The change in serum concentrations of estradiol at baseline and 14 days was measured.
Measured: Baseline and 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2006 (estimated)
- Study startJun 2006
- Primary completionOct 2008
- Study completionNov 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Vered Stearns, MD, Principal investigator, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00354640
- Sponsor's protocol ID
- J05100, CDR0000485361
- Other IDs
- P30CA006973, JHOC-J05100, JHOC-SKCCC-J05100
- Status last verified
- May 2013
- First submitted
- 19 Jul 2006
- Last updated
- 24 Jun 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Trial Assessing the Effect of Simvastatin on the Pharmacokinetics of Anastrozole
- ClinicalTrials.gov ID
- NCT00354640
- Acronym / sponsor ID
- J05100, CDR0000485361
- Conditions
- Breast Cancer
- Keywords
- breast cancer, breast cancer in situ, ductal breast carcinoma in situ, stage I breast cancer, stage II breast cancer, stage IIIA breast cancer, stage IIIB breast cancer, stage IIIC breast cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Jun 2006
- Primary completion
- Oct 2008 (actual)
- Study completion
- Nov 2011 (actual)
- First posted
- 20 Jul 2006 (estimated)
- Results
- Posted 24 Jun 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
RATIONALE: Chemoprevention is the use of certain drugs to keep cancer from forming, growing, or coming back. The use of simvastatin and anastrozole may stop cancer from forming, growing, or coming back in patients with invasive breast cancer, ductal carcinoma in situ, or a high risk of breast cancer.
PURPOSE: This phase II trial is studying how well giving simvastatin together with anastrozole works in treating postmenopausal women with invasive breast cancer, ductal carcinoma in situ, or a high risk of breast cancer.
Detailed description
OBJECTIVES:
Primary
- Assess the effects of concurrent anastrozole and simvastatin on anastrozole's steady-state concentration in postmenopausal women with history of invasive breast cancer or ductal carcinoma in situ or at high risk for developing breast cancer.
Secondary
- Study the effect of concurrent simvastatin and anastrozole on estrogen suppression in these patients.
OUTLINE: This is a pilot study.
Patients continue to receive oral anastrozole once daily (as prior to study entry). They also receive oral simvastatin once daily for 14-18 days in the absence of unacceptable toxicity or diagnosis of new or recurrent breast cancer.
Patients undergo blood sample collection at baseline and after study therapy for analysis of anastrozole and hormone (estradiol and estrogen) concentrations.
PROJECTED ACCRUAL: A total of 20 patients will be accrued for this study.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Anastrozole and Simvastatin | Experimental | Drug: anastrozole, Drug: simvastatin, Other: pharmacological study, Procedure: adjuvant therapyThis is a pharmacological study for women on anastrozole as adjuvant therapy for breast cancer to receive concurrent simvastatin for up to 14 days. |
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 |
|---|---|---|
| anastrozoleAlso: Arimidex1 milligram tablet PO QD for 14 days | Drug | Anastrozole and Simvastatin |
| simvastatinAlso: Zocor40 milligram tablet PO QD for 14 days | Drug | Anastrozole and Simvastatin |
| pharmacological studylaboratory analysis | Other | Anastrozole and Simvastatin |
| adjuvant therapylaboratory analysis | Procedure or surgery | Anastrozole and Simvastatin |
Primary outcome
Change in Blood Concentrations
Time frame: Baseline and 14 days
The change in blood concentrations of anastrozole at baseline and 14 days was measured.
1 secondary outcome
Change in Serum Estradiol Levels
Time frame: Baseline and 14 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Vered Stearns, MD principal investigator
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing anastrozole, simvastatin and pharmacological study in people with Breast Cancer, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins 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?
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 24 Jun 2013. 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 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?
Yes. Results are posted in the registry (first posted 24 Jun 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 Blood Concentrations (time frame: Baseline and 14 days). 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 24 Jun 2013.