Phase 3
N=527
The Use of Zoledronic Acid to Prevent Cancer-treatment Bone Loss in Post-menopausal Women Receiving Adjuvant Letrozole for Breast Cancer
Breast Cancer
Bottom Line
View on ClinicalTrials.gov: NCT00171314 ↗Enrolled (actual)
527
Serious AEs
19.7%
Results posted
Apr 2012
Primary outcome: Primary: Percent Change in Lumbar Spine (L2-L4) BMD After 12 Months of Letrozole Therapy — 2.680; -3.314 Percent Change
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Zoledronic acid (Drug); Letrozole (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Novartis Pharmaceuticals
- Primary completion
- Nov 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent Change in Lumbar Spine (L2-L4) BMD After 12 Months of Letrozole Therapy |
2.680; -3.314 | — |
| SECONDARY Percent Change in Lumbar Spine (L2-L4) BMD at 2 Years, 3 Years, 4 Years and 5 Years |
4.136; -3.924; 4.777; -4.297; 5.462; -4.746 | — |
| SECONDARY Percent Change in Lumbar Spine (L1-L4) BMD at Year 1, Year 2, Year 3, Year 4 and Year 5 |
2.330; -3.532; 3.994; -3.934; 4.523; -4.292 | — |
| SECONDARY Percent Change in Total Hip BMD at Year 1, Year 2, Year 3, Year 4 and Year 5 |
1.637; -1.644; 2.119; -2.628; 1.991; -3.011 | — |
| SECONDARY Percentage of Participants With Radiological (Vertebra) Fractures Which Were Not Present at Baseline But Were Present at Year 3 |
2.8; 3.3 | — |
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT00171314). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.