The Use of Zoledronic Acid to Prevent Cancer-treatment Bone Loss in Post-menopausal Women Receiving Adjuvant Letrozole for Breast Cancer

Novartis

Status and phase: Completed; Phase 3

Conditions: Breast Cancer

Treatments: Drug: Letrozole; Drug: Zoledronic acid

Study type: Interventional

Funder types: Industry

Identifiers

NCT00171314

CFEM345D2406

Details and patient eligibility

About

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.

Enrollment: 527 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Stage I-IIIa breast cancer
• Postmenopausal
• Recent surgery for breast cancer

Exclusion criteria

• Metastatic disease
• Invasive bilateral disease
• Clinical or radiological evidence of existing fracture in spine or hip

Other protocol-defined inclusion / exclusion criteria may apply.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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527 participants in 2 patient groups

Upfront Zoledronic Acid

Experimental group

Description:

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

Treatment:

Drug: Zoledronic acid

Drug: Letrozole

Delayed Zoledronic Acid

Experimental group

Description:

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

Treatment:

Drug: Zoledronic acid

Drug: Letrozole