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

NCT00171314 | Completed Phase 3 Results

• 1 other identifier: CFEM345D2406
• Study Type: interventional
• Target: 527
• Locations: 9 countries
• Sites: 49

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.

Conditions

Breast Cancer

Keywords

breast cancer; letrozole; zoledronic acid; adjuvant; postmenopausal

Outcome Measures

Primary Outcomes (1)

• 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.

  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

  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

  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

  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

  Year 3

Study Arms (2)

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

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

Drug: Zoledronic acid; Drug: Letrozole

Interventions

Zoledronic acid DRUG

Zoledronic acid 4 mg Intravenous (IV)15 minute infusion every 6 months.

Also known as: ZOL446, Zometa®

Delayed Zoledronic Acid; Upfront Zoledronic Acid

Letrozole DRUG

Letrozole tablets 2.5 mg/day/taken orally for 5 years.

Also known as: Femara®

Delayed Zoledronic Acid; Upfront Zoledronic Acid

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (49)

Novartis Investigative Site

Buenos Aires, Argentina

Location

Novartis Investigative Site

Rosario - Santa Fe, Argentina

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Novartis Investigative Site

Aalst, Belgium

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Novartis Investigative Site

Anderlecht, Belgium

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Novartis Investigative Site

Bonheiden, Belgium

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Novartis Investigative Site

Brasschaat, Belgium

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Novartis Investigative Site

Brussels, Belgium

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Novartis Investigative Site

Edegem, Belgium

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Novartis Investigative Site

Hasselt, Belgium

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Novartis Investigative Site

Leuven, Belgium

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Novartis Investigative Site

Libramont-Chevigny, Belgium

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Novartis Investigative Site

Liège, Belgium

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Novartis Investigative Site

Mons, Belgium

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Novartis Investigative Site

Ottignies, Belgium

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Novartis Investigative Site

Saint Niklaas, Belgium

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Novartis Investigative Site

Wilrijk, Belgium

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Novartis Investigative Site

Yvoir, Belgium

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Novartis Investigative Site

Limoges, France

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Mougins, France

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Novartis Investigative Site

Périgueux, France

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Novartis Investigative Site

Rennes, France

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Novartis Investigative Site

Saint-Brieuc, France

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Novartis Investigative Site

Saint-Herblain, France

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Novartis Investigative Site

Toulon, France

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Novartis Investigative Site

Vandœuvre-lès-Nancy, France

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Novartis Investigative Site

Genova, Italy

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Novartis Investigative Site

Ivrea, Italy

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Novartis Investigative Site

Lecco, Italy

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Novartis Investigative Site

Monteforte Irpino (Av), Italy

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Novartis Investigative Site

Pietra Ligure, Italy

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Novartis Investigative Site

Roma, Italy

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Novartis Investigative Site

Sassari, Italy

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Novartis Investigative Site

Torino, Italy

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Novartis Investigative Site

Vicenza, Italy

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Novartis Investigative Site

Eindhoven, Netherlands

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Novartis Investigative Site

Hoogeveen, Netherlands

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Novartis Investigative Site

Nijmegen, Netherlands

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Novartis Investigative Site

The Hague, Netherlands

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Novartis Investigative Site

Riyadh, Saudi Arabia

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Novartis Investigative Site

Cape Town, South Africa

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Novartis Investigative Site

Durban, South Africa

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Novartis Investigative Site

Johannesburg, South Africa

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Novartis Investigative Site

Daegu, South Korea

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Novartis Investigative Site

Jeollanam-do, South Korea

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Novartis Investigative Site

Seoul, South Korea

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Novartis Investigative Site

Barcelona, Spain

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Novartis Investigative Site

Córdoba, Spain

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Novartis Investigative Site

Madrid, Spain

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Novartis Investigative Site

Valencia, Spain

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Zoledronic Acid; Letrozole

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Diphosphonates; Organophosphonates; Organophosphorus Compounds; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Nitriles; Triazoles

Results Point of Contact

• Title: Novartis Pharmaceuticals
• Organization: Novartis Pharamaceuticals

862-778-8300

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 12, 2005
• First Posted: September 15, 2005
• Study Start: March 1, 2004
• Primary Completion: November 1, 2010
• Last Updated: April 11, 2012
• Results First Posted: April 11, 2012

Record last verified: 2012-03

Locations

FR (8); NL (4); KR (3); ES (4); IT (9); SA (1); ZA (3); AR (2); BE (15)