Organisation for Oncology and Translational Research
Age
18–any
Sex
FEMALE
Healthy volunteers
Not accepted
You may be eligible if
Postmenopausal women
Primary tumor greater than 2 cm in diameter
Histologically proven invasive breast cancer
Positive estrogen receptor
Negative HER-2 receptor
ECOG performance status ≤ 1 or Karnofsky performance status ≥ 70%
Laboratory values must be follows:
Absolute neutrophil count ≥ 1,500/mm3; Platelets ≥ 100,000/mm3; Hemoglobin ≥ 9 g/dL; Bilirubin ≤ 1.5 × institutional upper limit of normal (ULN); Serum Creatinine ≤ 1.5 × ULN; Alkaline phosphatase ≤ 2 × ULN; AST and ALT ≤ 2 × ULN; Normal finding of ECG - QTc ≤ 470 msec (based on the mean value of the triplicate ECGs); Left ventricular ejection fraction (LVEF) ≥ 60%.
Able to give written informed consent form
Able to follow prescription instructions reasonably well
You may not be if
Male
Severe psychiatric disorder
Prior history of other malignancy within 5 years of study entry, aside from basal cell carcinoma or the skin or carcinoma-in-situ of the uterine cervix
Locally advanced breast cancer (T3N1 or Any T4 or Any N2, N3), or distant metastasis
Multifocal or multicentric breast cancer except that the largest lesion is greater than 2cm
Major surgery within 3 weeks of first study treatment
Current use or anticipated need for:
Food or drugs that are known strong CYP3A4 inhibitors; drugs that are known strong CYP3A4 inducers
Severe cardiovascular diseases in the previous 6 months
Active inflammatory bowel disease or chronic diarrhea
Renal Impairment
Poor adrenal function
Hepatitis B and/or hepatitis C carriers (unless with normal hepatic function)
Known human immunodeficiency virus infection
Known hypersensitivity to anti-aromatase drugs or any cell cycle inhibitor
Other severe acute or chronic medical or psychiatric condition, or laboratory abnormality that would impart, in the judgment of the investigator, excess risk associated with study participation or study drug administration, or which, in the judgment of the investigator, would make the patient inappropriate for entry into this study
Clareo Health | Letrozole and CDK 4/6 Inhibitor for ER Positive, HER2 Negative Breast Cancer in Postmenopausal Women
