A Phase I Prevention Study of Atorvastatin in Women at Increased Risk for Breast Cancer (NCT00637481) | Clinical Trial Compass
CompletedPhase 1
A Phase I Prevention Study of Atorvastatin in Women at Increased Risk for Breast Cancer
United States66 participantsStarted 2008-03
Plain-language summary
Chemoprevention is the use of certain drugs to keep cancer from forming. The use of atorvastatin (Lipitor) may prevent breast cancer. This randomized phase I trial is studying the best dose of atorvastatin in preventing breast cancer in women at increased risk for breast cancer.
Who can participate
Age range18 Years – 72 Years
SexFEMALE
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Inclusion Criteria:
* Women at increased risk for breast cancer, defined by one of the following:
* 5 year projected Gail risk of greater than 1.67%
* Previous diagnosis of atypical hyperplasia (AH) or lobular carcinoma in situ (LCIS) (per participating institution's pathology review), or ductal carcinoma in situ (participants could have received any type of surgery and radiation as long as they have an intact opposite breast)
* The participant must have been properly informed of the study and must sign an informed consent to be able to be enrolled in the study; the informed consent document must be signed, witnessed, and dated prior to start of the study
* Normal physical exam and bilateral mammogram that shows no evidence of suspicious, malignant disease, or uncharacterized lesions within last 12 months and no evidence of any active other cancer
* Eastern Cooperative Oncology Group (ECOG) performance status =\< 1 (Karnofsky greater than or equal to 70%)
* Leukocytes greater than 3,000/uL
* Platelets greater than 100,000/uL
* Total bilirubin within normal institutional limits
* AST (SGOT)or /ALT (SGPT) =\< 1.5 X institutional ULN
* Creatinine within normal institutional limits
* CPK, PTT, PT within normal institutional limits (up to 1 month prior to randomization)
* The effects of atorvastatin on the developing human fetus at the recommended therapeutic dose are unknown; for this reason, women of child-bearing potential must agree to use adequate contraception (barrier…
What they're measuring
1
Atorvastatin induced changes in proliferation rate measured by Ki-67