Dose Escalation Study in Female Subjects With Breast Cancer Receiving Aromatase Inhibitor or Tamoxifen

Inclusion Criteria:

* Be a female of any race between the ages of 30-70 years.
* History of breast cancer and presently taking an aromatase inhibitor or tamoxifen.
* Naturally menopausal: ≥ 12 months spontaneous amenorrhea or \> 6 but \< 12 months amenorrhea with a serum follicle stimulating hormone (FSH) level of \> 40 mIU/mL (Milli-international Units Per Milliliter).
* Surgically menopausal with an FSH level \> 40 mIU/mL.
* Have a minimum of 7 moderate to severe hot flushes/day or 50 moderate to severe hot flushes per week, as verified for both weeks during the 14-day Screening Phase, prior to enrollment into the treatment phase of the study.
* Able to read, understand and complete the required subject diary.
* Willing and able to complete the daily subject diary, attend all study visits, and participate in all study procedures, including PK blood draws.

Exclusion Criteria:

* Childbearing potential, including pregnancy, or lactation.
* Undiagnosed abnormal genital bleeding.
* Significant day-to-day variability in hot flushes.
* Participation in another clinical trial within 30 days prior to screening or during the study.
* Legal incapacity or limited legal capacity.
* Chronic renal (serum creatinine \> 2.0 mg/dL) or hepatic disease \[SGPT (ALT) or SGOT (AST) \> 2X normal limits\].
* Gastrointestinal, liver, kidney or other conditions which could interfere with the absorption, distribution, metabolism or excretion of Q-122.
* Untreated overt hyperthyroidism.
* Use of thyroid medication of less than 12 weeks on a stable dose.
* Any clinically important systemic disease in the judgement of the investigator.
* Inability to complete all study visits and study assessments for scheduling or other reasons.
* Any other reason which in the investigator's opinion makes the subject unsuitable for a clinical trial.
* Abnormal laboratory findings including:

  1. Hematocrit \< 30% or hemoglobin \< 9.5 gm/dL
  2. Fasting blood sugar \> 140 mg/dL
  3. Fasting serum triglycerides \> 300 mg/dL
  4. Fasting SGOT, SGPT, GGT, or bilirubin greater than twice the upper limit of normal (a subject will not be excluded if a second measurement is less than twice the upper limit of normal)
  5. Creatinine \> 2.0 mg/dL