Trial · NCT00285857
Phase 2 Study of Lovastatin as Breast Cancer Chemoprevention
NCT00285857, Phase 2, Terminated, Stanford University; results first posted 2017-03-09
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Phase 2 Study of Lovastatin as Breast Cancer Chemoprevention. Trials, record NCT00285857. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00285857
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Phase 2 Study of Lovastatin as Breast Cancer Chemoprevention
- NCT number
- NCT00285857
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 30 participants, actual
- Lead sponsor
- Stanford University
- Conditions
- Breast Cancer
- Interventions
- Lovastatin
- First posted
- 2006-02-02
- Last updated
- 2017-03-09
- Results first posted
- 2017-03-09
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in the Incidence of Abnormal Breast Duct Cytology After Treatment With Lovastatin 80 mg/Day | 6 months | Assessed on that basis of pre- and post-treatment evaluation with RPFNA (random periareolar fine needle aspiration). All subjects received a prescription for lovastatin 80 mg/day, to be taken as 40 mg twice-a-day. Cytology was qualitatively and quantitatively, using the Masood semiquantitative scale to assign a number to each specimen, with higher numbers indicating increasing degrees of abnormality, as follows: 06-10 Non-proliferative breast disease (NPBD) 11-14 Proliferative breast disease without atypia (PBD-A) 15-18 Proliferative breast disease with atypia (PBD+A) 19-24 Carcinoma in situ and invasive cancer (CIS/IC) If no cells could be obtained after multiple RPFNA attempts, the classification was acellular. Change from NPBD to PBD-A was considered Unfavorable. Change from NPBD to Acellular was considered Equivocal. Change from PBD-A to NPBD was considered Favorable. |
| Secondary | Change in Mammographic Density Before and After Treatment With Lovastatin 80 mg/Day | 6 months | Bilateral mammography was performed at study entry (before lovastatin therapy) and at study conclusion (after lovastatin therapy) . Mammograms were assessed for a decline in mean breast density, using the American College of Radiology Breast Imaging Reporting and Data System (BI-RAD) composition system for mammographic density assessment. Category 0 Need additional imaging evaluation 1. Negative 2. Benign 3. Probably benign 4. Suspicious abnormality 5. Highly suggestive of malignancy 6. Known biopsy-proven malignancy |
| Secondary | Change in Total Cholesterol After Treatment With Lovastatin 80 mg/Day | 6 months | |
| Secondary | Change in Low Density Lipoprotein (LDL) After Treatment With Lovastatin 80 mg/Day | 6 months |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change in the Incidence of Abnormal Breast Duct Cytology After Treatment With Lovastatin 80 mg/Day | 6 months | Participants either at least one of the following:~* Deleterious germline mutation in BRCA1, BRCA2, CDH1, or TP53~* Lifetime breast cancer risk of breast cancer of 20 % as estimated by the Claus model~* Personal history of estrogen receptor andprogesterone receptor-negative breast cancer. | participants | NUMBER |
| SECONDARY | Change in Mammographic Density Before and After Treatment With Lovastatin 80 mg/Day | 6 months | Outcome reported as the change in mean mammographic density with standard deviation (SD) of the post-treatment measurements. | BI-RADS | MEAN |
| SECONDARY | Change in Total Cholesterol After Treatment With Lovastatin 80 mg/Day | 6 months | mg/dL | MEAN | |
| SECONDARY | Change in Low Density Lipoprotein (LDL) After Treatment With Lovastatin 80 mg/Day | 6 months | Change in mean of LDL level, with standard deviation of the values at | mg/dL | MEAN |
Source ClinicalTrials.gov
Results by group18
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change in the Incidence of Abnormal Breast Duct Cytology After Treatment With Lovastatin 80 mg/Day | Baseline Non-proliferative Breast Disease (NPBD) | Post-treatment NPBD | 8 | participants | |
| Change in the Incidence of Abnormal Breast Duct Cytology After Treatment With Lovastatin 80 mg/Day | Baseline Proliferative Breast Disease Without Atypia (PBD-A) | Post-treatment NPBD | 5 | participants | |
| Change in the Incidence of Abnormal Breast Duct Cytology After Treatment With Lovastatin 80 mg/Day | Baseline Biopsy Acellular | Post-treatment NPBD | 1 | participants | |
| Change in the Incidence of Abnormal Breast Duct Cytology After Treatment With Lovastatin 80 mg/Day | Baseline Non-proliferative Breast Disease (NPBD) | Post-treatment PBD-A | 2 | participants | |
| Change in the Incidence of Abnormal Breast Duct Cytology After Treatment With Lovastatin 80 mg/Day | Baseline Proliferative Breast Disease Without Atypia (PBD-A) | Post-treatment PBD-A | 7 | participants | |
| Change in the Incidence of Abnormal Breast Duct Cytology After Treatment With Lovastatin 80 mg/Day | Baseline Biopsy Acellular | Post-treatment PBD-A | 0 | participants | |
| Change in the Incidence of Abnormal Breast Duct Cytology After Treatment With Lovastatin 80 mg/Day | Baseline Non-proliferative Breast Disease (NPBD) | Post-treatment PBD+A | 0 | participants | |
| Change in the Incidence of Abnormal Breast Duct Cytology After Treatment With Lovastatin 80 mg/Day | Baseline Proliferative Breast Disease Without Atypia (PBD-A) | Post-treatment PBD+A | 0 | participants | |
| Change in the Incidence of Abnormal Breast Duct Cytology After Treatment With Lovastatin 80 mg/Day | Baseline Biopsy Acellular | Post-treatment PBD+A | 0 | participants | |
| Change in the Incidence of Abnormal Breast Duct Cytology After Treatment With Lovastatin 80 mg/Day | Baseline Non-proliferative Breast Disease (NPBD) | Post-treatment CIS/IC | 0 | participants |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Lovastatin 80 mg/Day | 30 | |
| Overall Study | COMPLETED | Lovastatin 80 mg/Day | 26 | |
| Overall Study | NOT COMPLETED | Lovastatin 80 mg/Day | 4 |
Source ClinicalTrials.gov
Adverse events3
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Myalgia | Musculoskeletal and connective tissue disorders | Lovastatin | 1 | 30 | 1 |
| other | Arthralgia | Musculoskeletal and connective tissue disorders | Lovastatin | 1 | 30 | 1 |
| other | Dyspepsia | Gastrointestinal disorders | Lovastatin | 1 | 30 | 1 |
Source ClinicalTrials.gov
Adverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Lovastatin | ||
| Total, other adverse events | Lovastatin | 3 | 30 |
| Total, serious adverse events | Lovastatin | 0 | 30 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 24166281 | RESULT |
Source PubMed
Grants0
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.
None in this release.
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/NCT00285857
GET https://conductscience.org/api/trials/v1/NCT00285857/registered