Breast CancerPhase 3NCT00171314
The Use of Zoledronic Acid to Prevent Cancer-treatment Bone Loss in Post-menopausal Women Receiving Adjuvant Letrozole for Breast Cancer
A Phase 3 study testing Zoledronic acid and Letrozole in people with Breast Cancer, run by Novartis Pharmaceuticals at 49 sites in 9 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Zoledronic acid and Letrozole
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 527 participants
- Where
- 49 sitesin 9 countries
- Study dates
- Mar 2004to Nov 2010
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Stage I-IIIa breast cancer
- Postmenopausal
- Recent surgery for breast cancer
Who cannot join
- 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 locations and contacts
49 sites in 9 countries.
49 sites in 9 countries
Belgium15 sites
Novartis Investigative Site
Aalst
Novartis Investigative Site
Anderlecht
Novartis Investigative Site
Bonheiden
Novartis Investigative Site
Brasschaat
Novartis Investigative Site
Brussels
Novartis Investigative Site
Edegem
Novartis Investigative Site
Hasselt
Novartis Investigative Site
Leuven
Novartis Investigative Site
Libramont-Chevigny
Novartis Investigative Site
Liège
Novartis Investigative Site
Mons
Novartis Investigative Site
Ottignies
Novartis Investigative Site
Saint Niklaas
Novartis Investigative Site
Wilrijk
Novartis Investigative Site
Yvoir
Italy9 sites
Novartis Investigative Site
Genova
Novartis Investigative Site
Ivrea
Novartis Investigative Site
Lecco
Novartis Investigative Site
Monteforte Irpino (Av)
Novartis Investigative Site
Pietra Ligure
Novartis Investigative Site
Roma
Novartis Investigative Site
Sassari
Novartis Investigative Site
Torino
Novartis Investigative Site
Vicenza
France8 sites
Novartis Investigative Site
Limoges
Novartis Investigative Site
Mougins
Novartis Investigative Site
Périgueux
Novartis Investigative Site
Rennes
Novartis Investigative Site
Saint-Brieuc
Novartis Investigative Site
Saint-Herblain
Novartis Investigative Site
Toulon
Novartis Investigative Site
Vandœuvre-lès-Nancy
Netherlands4 sites
Novartis Investigative Site
Eindhoven
Novartis Investigative Site
Hoogeveen
Novartis Investigative Site
Nijmegen
Novartis Investigative Site
The Hague
Spain4 sites
Novartis Investigative Site
Barcelona
Novartis Investigative Site
Córdoba
Novartis Investigative Site
Madrid
Novartis Investigative Site
Valencia
South Africa3 sites
Novartis Investigative Site
Cape Town
Novartis Investigative Site
Durban
Novartis Investigative Site
Johannesburg
South Korea3 sites
Novartis Investigative Site
Daegu
Novartis Investigative Site
Jeollanam-do
Novartis Investigative Site
Seoul
Argentina2 sites
Novartis Investigative Site
Buenos Aires
Novartis Investigative Site
Rosario - Santa Fe
About this study
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.
- Conditions
- Breast Cancer
- Being tested
- Zoledronic acid, Letrozole
- Keywords
- breast cancer, letrozole, zoledronic acid, adjuvant, postmenopausal
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Zoledronic acidDrug
Also called ZOL446, Zometa®
Zoledronic acid 4 mg Intravenous (IV)15 minute infusion every 6 months.
LetrozoleDrug
Also called Femara®
Letrozole tablets 2.5 mg/day/taken orally for 5 years.
| Study group | Role | What they receive |
|---|---|---|
| Upfront Zoledronic Acid | Experimental | 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 Receives: Drug: Zoledronic acid; Drug: Letrozole |
| Delayed Zoledronic Acid | Experimental | 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 Receives: Drug: Zoledronic acid; Drug: Letrozole |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent Change in Lumbar Spine (L2-L4) BMD After 12 Months of Letrozole Therapy
Bone Mineral Density (BMD)is measured by dual energy x-ray absorptiometry (DXA).Percent Change = [(BMD at Visit - BMD at Baseline) / BMD at Baseline] * 100.
Measured: From Baseline - 12 months
Secondary outcomes (4)
Percent Change in Lumbar Spine (L2-L4) BMD at 2 Years, 3 Years, 4 Years and 5 Years
Bone Mineral Density (BMD)is measured by dual energy x-ray absorptiometry (DXA).Percent Change = [(BMD at Visit - BMD at Baseline) / BMD at Baseline] * 100.
Measured: From Baseline to Year 2, Year 3, Year 4, Year 5
Percent Change in Lumbar Spine (L1-L4) BMD at Year 1, Year 2, Year 3, Year 4 and Year 5
Bone Mineral Density (BMD)is measured by dual energy x-ray absorptiometry (DXA).Percent Change = [(BMD at Visit - BMD at Baseline) / BMD at Baseline] * 100.
Measured: From Baseline to Year 1, Year 2, Year 3, Year 4, Year 5
Percent Change in Total Hip BMD at Year 1, Year 2, Year 3, Year 4 and Year 5
Bone Mineral Density (BMD)is measured by dual energy x-ray absorptiometry (DXA).Percent Change = [(BMD at Visit - BMD at Baseline) / BMD at Baseline] * 100.
Measured: From baseline to Year 1, Year 2, Year 3, Year 4, Year 5
Percentage of Participants With Radiological (Vertebra) Fractures Which Were Not Present at Baseline But Were Present at Year 3
Radiological Fracture at 36 months which was not present at baseline = (new fracture/number participant analyzed)*100. Evaluation of radiological fractures were based on central lab X-ray data. A subject with multiple fractures at the same time or multiple fractures with the same grade is counted only once for that treatment.
Measured: Year 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2005 (estimated)
- Study startMar 2004
- Primary completionNov 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 527 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00171314
- Sponsor's protocol ID
- CFEM345D2406
- Status last verified
- Mar 2012
- First submitted
- 12 Sep 2005
- Last updated
- 11 Apr 2012
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Zoledronic Acid to Prevent Cancer-treatment Bone Loss in Post-menopausal Women Receiving Adjuvant Letrozole for Breast Cancer
- ClinicalTrials.gov ID
- NCT00171314
- Acronym / sponsor ID
- CFEM345D2406
- Conditions
- Breast Cancer
- Keywords
- breast cancer, letrozole, zoledronic acid, adjuvant, postmenopausal
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 527 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Mar 2004
- Primary completion
- Nov 2010 (actual)
- First posted
- 15 Sep 2005 (estimated)
- Results
- Posted 11 Apr 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Upfront Zoledronic Acid | Experimental | Drug: Zoledronic acid, Drug: LetrozoleZoledronic 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 |
| Delayed Zoledronic Acid | Experimental | Drug: Zoledronic acid, Drug: LetrozoleZoledronic 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Stage I-IIIa breast cancer
- Postmenopausal
- Recent surgery for breast cancer
Key exclusion criteria (4 listed)
- Metastatic disease
- Invasive bilateral disease
- Clinical or radiological evidence of existing fracture in spine or hip
- Other protocol-defined inclusion / exclusion criteria may apply.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Zoledronic acidAlso: ZOL446, Zometa®Zoledronic acid 4 mg Intravenous (IV)15 minute infusion every 6 months. | Drug | Delayed Zoledronic Acid, Upfront Zoledronic Acid |
| LetrozoleAlso: Femara®Letrozole tablets 2.5 mg/day/taken orally for 5 years. | Drug | Delayed Zoledronic Acid, Upfront Zoledronic Acid |
Primary outcome
Percent Change in Lumbar Spine (L2-L4) BMD After 12 Months of Letrozole Therapy
Time frame: From Baseline - 12 months
Bone Mineral Density (BMD)is measured by dual energy x-ray absorptiometry (DXA).Percent Change = [(BMD at Visit - BMD at Baseline) / BMD at Baseline] * 100.
4 secondary outcomes
Percent Change in Lumbar Spine (L2-L4) BMD at 2 Years, 3 Years, 4 Years and 5 Years
Time frame: From Baseline to Year 2, Year 3, Year 4, Year 5
Percent Change in Lumbar Spine (L1-L4) BMD at Year 1, Year 2, Year 3, Year 4 and Year 5
Time frame: From Baseline to Year 1, Year 2, Year 3, Year 4, Year 5
Percent Change in Total Hip BMD at Year 1, Year 2, Year 3, Year 4 and Year 5
Time frame: From baseline to Year 1, Year 2, Year 3, Year 4, Year 5
Percentage of Participants With Radiological (Vertebra) Fractures Which Were Not Present at Baseline But Were Present at Year 3
Time frame: Year 3
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
49 sites in 9 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Zoledronic acid and Letrozole in people with Breast Cancer, run by Novartis Pharmaceuticals at 49 sites in 9 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Apr 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 49 sites in Belgium, Italy, France, Netherlands, Spain and 4 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 11 Apr 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent Change in Lumbar Spine (L2-L4) BMD After 12 Months of Letrozole Therapy (time frame: From Baseline - 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Apr 2012.