Conditions: Breast Neoplasms
Keywords: Breast cancer Anti tumor potential Letrozole Zoledronic acid Neoadjuvant treatment Hormone responsive breast cancer
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 168
Healthy volunteers: no

Brief summary:
This study will evaluate the safety/efficacy of zoledronic acid when given by intravenous infusion every 4 weeks in addition to letrozole as endocrine therapy in postmenopausal patients with hormone responsive breast cancer

Detailed description:
Open-label, multicenter, randomized phase II trial over approx 6.5 months of neoadjuvant treatment with letrozole with or without zoledronic acid in postmenopausal patients with primary breast cancer. A total of approximately 850 patients were originally planned to be enrolled; primary study endpoint was the objective response rate (according to modified RECIST criteria) after 6 months of treatment. After the core study, patients willing to participate were followed-up for further 5 years.

Arms:
arm 1: Letrozole 2.5 mg/day oral letrozole for approximately 6.5 months neoadjuvent treatment arm 2: 2.5 mg/day oral letrozole for approximately 6.5 months neoadjuvant treatment plus zoledronic acid 4 mg i.v. q4w

Interventions: intervention 1: Letrozole intervention 2: Zolendronic Acid
Intervention descriptions: intervention 1: 2.5 mg.tablet. intervention 2: 4 mg or an adjusted dose based on renal function in 100 ml physiologic (o.9%) normal saline, (as an intravenous infusion over no less than 15 minutes)

Protocol document: