Study Events | Consenting/Screening | Baseline/Randomization | Intervention (12 month (52 ± 4 weeks)) | ||||||||
---|---|---|---|---|---|---|---|---|---|---|---|
Months 1–3 | Month 3 Visit (13 ± 2 weeks) | Months 4–6 | Month 6 Visit (26 ± 4 weeks) | Months 7–9 | Month 9 Visit (39 ± 2 weeks) | Months 10 –12 | Month 12 Visit (52 ± 4 weeks) | Follow up | |||
Consent, med records release form | x | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â |
Medical history, performance status | x | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â |
Anthropometric measurements | x | x | Â | Â | Â | x | Â | Â | Â | x | Â |
Vital signs (Temp, BP, Pulse) | x | x | Â | x | Â | x | Â | x | Â | x | Â |
Concomitant meds | x | x | Â | x | Â | x | Â | x | Â | x | Â |
Breast cancer risk questionnaire | x | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â |
Menstrual pattern/cycle review | x | x | Â | x | Â | x | Â | x | Â | x | Â |
Menstrual cycle diary | x | x | x | x | x | x | x | x | x | x | Â |
Fasting blood (CBC/Diff, CMP, lipids, FSHa, estradiola) | x | Â | Â | Â | Â | Â | Â | Â | Â | x | Â |
Fasting blood for research endpoints | Â | x | Â | Â | Â | x | Â | Â | Â | x | Â |
Urine pregnancy test | x | x | Â | x | Â | x | Â | x | Â | x | Â |
Urine for research endpoints | Â | x | Â | Â | Â | x | Â | Â | Â | x | Â |
AFFQ, AAFQb | Â | x | Â | Â | Â | Â | Â | Â | Â | x | Â |
Nipple aspirate fluid (NAF) collection | Â | x | Â | Â | Â | x | Â | Â | Â | x | Â |
Breast MRIc | Â | x | Â | Â | Â | x | Â | Â | Â | x | Â |
Core biopsy, if consented | Â | x | Â | Â | Â | x | Â | Â | Â | Â | Â |
Final eligibility assessment | Â | x | Â | Â | Â | Â | Â | Â | Â | Â | Â |
Randomization | Â | x | Â | Â | Â | Â | Â | Â | Â | Â | Â |
Dispense study agent | Â | x | Â | Â | Â | x | Â | Â | Â | Â | Â |
Intake calendar | Â | Â | x | x | x | x | x | x | x | x | Â |
Adverse events diary | Â | x | x | x | x | x | x | x | x | x | x |
Adverse events review | Â | x | Â | x | Â | x | Â | x | Â | x | x |
Return study agent | Â | Â | Â | Â | Â | x | Â | Â | Â | x | Â |
Compliance assessment | Â | Â | Â | x | Â | x | Â | x | Â | x | Â |
Case report form completion | x | x | Â | x | Â | x | Â | x | Â | x | x |
Telephone/email contactd | Â | Â | x | Â | x | Â | x | Â | x | Â | Â |