Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Phase I Dose-Finding Trial of Letrozole in Postmenopausal Women at High Risk for Breast Cancer
Brief Summary: This randomized phase I trial studies the side effects and the best dose of letrozole in preventing breast cancer in healthy postmenopausal women at high risk for breast cancer. Chemoprevention is the use of drugs to keep breast cancer from forming or coming back. The use of letrozole may keep cancer from forming in healthy postmenopausal women at high risk for breast cancer.


Options:
A: Arm Label: 1; Type: EXPERIMENTAL; Interventions: Drug: Aspirin, Drug: Vitamin E | Arm Label: 2; Type: EXPERIMENTAL; Interventions: Drug: Vitamin E, Behavioral: Placebo | Arm Label: 3; Type: EXPERIMENTAL; Interventions: Drug: Aspirin, Behavioral: Placebo | Arm Label: 4; Type: PLACEBO_COMPARATOR; Interventions: Behavioral: Placebo | Intervention Type: DRUG; Name: Aspirin; Assigned to Arm(s): 1, 3 | Intervention Type: DRUG; Name: Vitamin E; Assigned to Arm(s): 1, 2 | Intervention Type: BEHAVIORAL; Name: Placebo; Assigned to Arm(s): 2, 3, 4
B: Arm Label: Arm I (2.5 mg letrozole); Type: EXPERIMENTAL; Interventions: Drug: letrozole, Other: quality-of-life assessment, Other: laboratory biomarker analysis | Arm Label: Arm II (1.0 mg letrozole); Type: EXPERIMENTAL; Interventions: Drug: letrozole, Other: quality-of-life assessment, Other: laboratory biomarker analysis | Arm Label: Arm III (0.25 mg letrozole); Type: EXPERIMENTAL; Interventions: Drug: letrozole, Other: quality-of-life assessment, Other: laboratory biomarker analysis | Arm Label: Arm IV (2.5 mg letrozole); Type: EXPERIMENTAL; Interventions: Drug: letrozole, Other: quality-of-life assessment, Other: laboratory biomarker analysis | Intervention Type: DRUG; Name: letrozole; Assigned to Arm(s): Arm I (2.5 mg letrozole), Arm II (1.0 mg letrozole), Arm III (0.25 mg letrozole), Arm IV (2.5 mg letrozole) | Intervention Type: OTHER; Name: quality-of-life assessment; Assigned to Arm(s): Arm I (2.5 mg letrozole), Arm II (1.0 mg letrozole), Arm III (0.25 mg letrozole), Arm IV (2.5 mg letrozole) | Intervention Type: OTHER; Name: laboratory biomarker analysis; Assigned to Arm(s): Arm I (2.5 mg letrozole), Arm II (1.0 mg letrozole), Arm III (0.25 mg letrozole), Arm IV (2.5 mg letrozole)
C: Arm Label: 1; Type: ACTIVE_COMPARATOR; Interventions: Drug: Tibolone | Arm Label: 2; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo | Intervention Type: DRUG; Name: Tibolone; Assigned to Arm(s): 1 | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): 2
D: Intervention Type: DRUG; Name: hormone replacement therapy; Assigned to Arm(s): N/A | Intervention Type: DRUG; Name: estrogens; Assigned to Arm(s): N/A | Intervention Type: DRUG; Name: progestins; Assigned to Arm(s): N/A | Intervention Type: DRUG; Name: estrogen replacement therapy; Assigned to Arm(s): N/A | Intervention Type: BEHAVIORAL; Name: diet, fat-restricted; Assigned to Arm(s): N/A | Intervention Type: DRUG; Name: calcium; Assigned to Arm(s): N/A | Intervention Type: DRUG; Name: vitamin D; Assigned to Arm(s): N/A | Intervention Type: BEHAVIORAL; Name: dietary supplements; Assigned to Arm(s): N/A

Answer: B