Clinical Trials

Inclusion Criteria:

• Age: 25-85 years old.
• Women with a history of invasive breast cancer, DCIS, or LCIS, or are at high risk for developing breast cancer.
• Creatine labs drawn within 90 days as part of Standard of Care.
• Bothersome hot flashes (defined by their occurrence of two or more hot flashes a day and/or of sufficient severity to prompt the patient to seek therapeutic intervention).
• Presence of hot flashes for > 30 days prior to study entry.
• Ability to complete questionnaire(s) by themselves or with assistance.
• Ability to provide informed written consent.
• Life expectancy ≥ 6 months.
• Willing to work with the enrolling institution for follow-up (during the Active Monitoring Phase of the study).
• ECOG Performance Status (PS) = 0, 1.

Exclusion Criteria:

• Pregnancy (Assessed on Intake Questionnaire. Positive Answer exclusionary).
• Any of the following current (≤ 4 weeks prior) or planned therapies:
  • Antineoplastic chemotherapy (anti-HER2 agents allowed);
  • Androgens;
  • Systemic estrogens (topical vaginal estrogen OK);
  • Progestogens;
  • Tamoxifen, raloxifene and aromatase inhibitors are allowed, but patient must have been on a constant dose for at least 28 days and must not be expected to stop the medication during the study period;
  • SSRIs/SNRIs;
  • Gabapentin;
  • Clonidine;
  • Oxybutinin;
  • Stage IV or V renal disease or GFR < 30 in the last 90 days.