Trial · NCT00354640
Simvastatin and Anastrozole in Treating Postmenopausal Women With Ductal Carcinoma In Situ or Invasive Breast Cancer
NCT00354640, Phase 2, Completed, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins; results first posted 2013-06-24
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Simvastatin and Anastrozole in Treating Postmenopausal Women With Ductal Carcinoma In Situ or Invasive Breast Cancer. Trials, record NCT00354640. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00354640
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Simvastatin and Anastrozole in Treating Postmenopausal Women With Ductal Carcinoma In Situ or Invasive Breast Cancer
- NCT number
- NCT00354640
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 11 participants, actual
- Lead sponsor
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
- Conditions
- Breast Cancer
- Interventions
- anastrozole, simvastatin, pharmacological study, adjuvant therapy
- First posted
- 2006-07-20
- Last updated
- 2013-06-24
- Results first posted
- 2013-06-24
- Limitations and caveats
- Small sample size, difficulty in recruiting due to women either already taking a statin or on a different aromatase inhibitor.
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in Blood Concentrations | Baseline and 14 days | The change in blood concentrations of anastrozole at baseline and 14 days was measured. |
| Secondary | Change in Serum Estradiol Levels | Baseline and 14 days | The change in serum concentrations of estradiol at baseline and 14 days was measured. |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change in Blood Concentrations | Baseline and 14 days | Participants with blood samples for trough concentrations were included. | ng/ml | MEDIAN |
| SECONDARY | Change in Serum Estradiol Levels | Baseline and 14 days | Participants with blood samples for trough concentrations were included. | pmol/l | MEDIAN |
Source ClinicalTrials.gov
Results by group3
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change in Blood Concentrations | Anastrozole and Simvastatin | Anastrozole concentration | 4.2 | Full Range -6.2 to 22.1 | ng/ml |
| Change in Blood Concentrations | Anastrozole and Simvastatin | Hydroxyanastrozole concentration | -0.03 | Full Range -0.14 to 0.08 | ng/ml |
| Change in Serum Estradiol Levels | Anastrozole and Simvastatin | -3.0 | Full Range -19.0 to 9.5 | pmol/l |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Anastrozole and Simvastatin | 11 | |
| Overall Study | COMPLETED | Anastrozole and Simvastatin | 11 | |
| Overall Study | NOT COMPLETED | Anastrozole and Simvastatin | 0 |
Source ClinicalTrials.gov
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Anastrozole and Simvastatin | ||
| Total, other adverse events | Anastrozole and Simvastatin | 0 | 11 |
| Total, serious adverse events | Anastrozole and Simvastatin | 0 | 11 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants1
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| P30CA006973 | Regional Oncology Research Center | NELSON, WILLIAM GEORGE | JOHNS HOPKINS UNIVERSITY | NATIONAL CANCER INSTITUTE | 1985 to 2025 |
Source NIH RePORTER
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00354640
GET https://conductscience.org/api/trials/v1/NCT00354640/registered