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Phase 2 Study of Lovastatin as Breast Cancer Chemoprevention
A Phase 2 Trial of Lovastatin for Modification of Abnormal Breast Duct Cytology and Risk-Associated Biomarkers in Women at High Inherited Risk of Breast Cancer
Studie Overzicht
Gedetailleerde beschrijving
The study evaluates if a 6-month course of oral lovastatin at 80 mg/day (as 40 mg twice-a-day) would decrease abnormal breast duct cytology in women with a high inherited breast cancer risk. Breast duct cytology was assessed as hyperplasia or hyperplasia with atypia, as measured by random periareolar fine needle aspiration (rpFNA), of breast duct cells.
A stratified analysis of this objective will be performed according to BRCA mutation status (absence or presence of an inherited deleterious BRCA1 or BRCA2 mutation).
Additional objectives of the study are to:
- Assess change in mammographic density, which is known to associate with breast cancer risk, before and after treatment with lovastatin
- Asess incidence of breast cancers and new high-risk breast lesions, including atypical hyperplasia, ductal or lobular carcinoma in situ, or radial scar.
Assess change in other breast cancer risk-associated biomarkers in rpFNA specimens, including:
- Ki-67 (a marker of cell proliferation)
- Estrogen receptor (ER)
- Progesterone receptor (PR)
- HER/2-neu over-expression
- Susceptibility to DNA damage
Studietype
Inschrijving (Werkelijk)
Fase
- Fase 2
Contacten en locaties
Studie Locaties
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California
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Stanford, California, Verenigde Staten, 94305
- Stanford University Cancer Center
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
INCLUSION CRITERIA
- Female
Increased inherited risk of breast cancer, as defined by:
- Known deleterious mutation in BRCA1, BRCA2, or other high-risk mutation
- Family history conveying at least a 2-fold increase in breast cancer risk
- ECOG performance status 0
- Normal organ and marrow function, including complete blood count and comprehensive metabolic panel within normal institutional limits
- Subject agreement to limit alcoholic beverage consumption to three alcoholic drinks per week.
EXCLUSION CRITERIA
- Prior history of invasive breast cancer less than 2 years previously (EXCEPTION: stage III or lower breast cancer > 2 years ago)
- Current or history of other cancers (EXCEPTION: non-melanoma skin cancer, or stage III or cancer without evidence of recurrence for 5 years
- Initial mammogram, breast MRI, or clinical breast examination prompts recommendation for biopsy by study investigators.
- Evidence of malignant cytology on initial rpFNA.
- Use of other investigational agents.
- Use of tamoxifen or selective estrogen response modifiers (SERMS), including raloxifene, within the last 2 years.
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to lovastatin.
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection; symptomatic congestive heart failure; unstable angina pectoris; cardiac arrhythmia; or psychiatric illness/social situations that would limit compliance with study requirements.
- Currently receiving lovastatin and cyclosporine, gemfibrozil, erythromycin, fibrates or niacin, (unless discontinued for study participation)
- No evidence of active liver disease, nor elevation of serum transaminases (prior history of liver disease, if not currently active, is not an exclusion)
- No evidence of myopathy or myositis, including symptoms of generalized muscle aches or weakness, muscle tenderness, or elevation in creatine phosphokinase.
- Lactating (breastfeeding)
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: NVT
- Interventioneel model: Opdracht voor een enkele groep
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Experimenteel: Lovastatin 80 mg/day
Lovastatin 80 mg/day as 40 mg orally twice daily, for 6 months.
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Lovastatin 80 mg/day as 40 mg orally twice daily. Lovastatin is approved by FDA as a cholesterol-lowering agent.
Andere namen:
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Change in the Incidence of Abnormal Breast Duct Cytology After Treatment With Lovastatin 80 mg/Day
Tijdsspanne: 6 months
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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. |
6 months
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Change in Mammographic Density Before and After Treatment With Lovastatin 80 mg/Day
Tijdsspanne: 6 months
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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
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6 months
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Change in Total Cholesterol After Treatment With Lovastatin 80 mg/Day
Tijdsspanne: 6 months
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6 months
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Change in Low Density Lipoprotein (LDL) After Treatment With Lovastatin 80 mg/Day
Tijdsspanne: 6 months
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6 months
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Medewerkers en onderzoekers
Sponsor
Onderzoekers
- Hoofdonderzoeker: James Ford, MD, Stanford University
Publicaties en nuttige links
Studie record data
Bestudeer belangrijke data
Studie start
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
- Huidziektes
- Neoplasmata
- Neoplasmata per site
- Borst ziekten
- Borstneoplasmata
- Moleculaire mechanismen van farmacologische werking
- Enzymremmers
- Antimetabolieten
- Middelen tegen cholesterol
- Hypolipidemische middelen
- Vetregulerende middelen
- Hydroxymethylglutaryl-CoA-reductaseremmers
- Lovastatine
- L 647318
- Dihydromevinoline
Andere studie-ID-nummers
- IRB-13732
- BRSNSTU0010 (Andere identificatie: OnCore)
- 95505 (Andere identificatie: Stanford University Alternate IRB Approval Number)
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .
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