Dose Optimization of Rosuvastatin in Early Stage and Metastatic Estrogen Receptor Positive Breast Cancer Patients on Endocrine Therapy

This is an interventional treatment trial for Breast Cancer focused on measuring Estrogen Receptor Positive Read More

Inclusion Criteria:

• Women with ER+/PR+ HER2-negative breast cancer initiating neoadjuvant endocrine therapy with curative intent OR initiating endocrine therapy for the treatment of metastatic breast cancer with a biopsy accessible primary breast tumor
• The patients may start any FDA approved endocrine therapy (with which they have not been previously treated) at week 4 of the trial except for tamoxifen
• Palbociclib can be started at week 4, if indicated
• Patients with metastatic disease currently on endocrine therapy must be willing to stop endocrine therapy for 2 weeks prior to starting the study and to switch to a new endocrine therapy on the study (at week 4)
• Intact breast tumor present and size measuring at least 1cm at enrollment
• Post-menopausal at enrollment (age ≥ 60, age ≤ 60 and amenorrhea for ≥12 months in the absence of chemotherapy, tamoxifen, ovarian suppression and FSH/estradiol in the post-menopausal range)
• ECOG ≤ 2
• Can be on other endocrine therapy if willing to change a different endocrine therapy agent for the trial
• Must have at least one FDA approved endocrine therapy option with which the patient has not received prior treatment
• Life expectancy > 12 weeks
• Laboratory criteria: normal renal function: creatinine < 1.5 x upper limit of normal (ULN)), liver function: bilirubin < 2 x ULN, transaminases < 2 x ULN and blood counts: WBC ≥ 2.0, Neutrophils ≥1250, platelets ≥50,000, Hemoglobin ≥ 8.
• Age > 18 years
• Patients must have the ability to give informed consent.
• Patients must have a signed informed consent form prior to enrollment on study. -

Exclusion Criteria:

• Statin use in the last 6 months
• Patient has been treated with all FDA approved endocrine therapies or has been treated with all FDA approved endocrine therapies except for tamoxifen (tamoxifen is excluded from the trial)
• Active liver disease with elevated transaminases > 2x ULN
• Known hypersensitivity to rosuvastatin
• Any history of any other cancer (except non-melanoma skin cancer or carcinoma in-situ of the cervix) unless the patient has been in remission and off all other cancer therapy for at least 3 years.
• Patients should have no significant psychiatric illness or medical illness that would preclude the ability to comply with the protocol.
• Patients currently taking medications with known rosuvastatin interactions including cyclosporine, gemfibrozil, lopinavir/ritonavir, atazanavir/ritonavir, coumarin anticoagulants, colchicine, fenofibrates, and niacin.