Conditions: Breast Cancer
Keywords: breast cancer letrozole zoledronic acid adjuvant postmenopausal
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 527
Healthy volunteers: no

Brief summary:
Post-menopausal breast cancer patients will receive letrozole 2.5 mg daily for the treatment of breast cancer and will be randomized to a treatment group to receive either upfront zoledronic acid 4 mg IV 15-minute infusion every 6 months or delayed start zoledronic acid 4 mg IV 15-minute infusion every 6 months. Delayed start zoledronic acid will be initiated when either the Bone Mineral Density T-score is below -2 Standard Deviations at either the lumbar spine or hip or any clinical fracture unrelated to trauma or an asymptomatic fracture discovered at the month 36 scheduled visit. Letrozole 2.5 mg will be given daily for 5 years.

Detailed description:

Arms:
arm 1: Zoledronic acid 4 mg Intravenous (IV) 15 minute infusion every 6 months for 5 years beginning on Day 1. All participants took Letrozole tablets 2.5 mg/day for 5 years beginning on Day 1 arm 2: Zoledronic acid 4 mg Intravenous (IV) 15 minute infusion every 6 months beginning when one of the following occurred: BMD T-score \<= -2.0 SD at either the lumbar spine or total hip, any clinical fracture unrelated to trauma or an asymptomatic fracture discovered at the Month 36 visit. All participants took Letrozole tablets 2.5 mg/day for 5 years beginning on Day 1

Interventions: intervention 1: Zoledronic acid intervention 2: Letrozole
Intervention descriptions: intervention 1: Zoledronic acid 4 mg Intravenous (IV)15 minute infusion every 6 months. intervention 2: Letrozole tablets 2.5 mg/day/taken orally for 5 years.

Protocol document: