Safety/Efficacy of Letrozole Monotherapy or in Combination With Zoledronic Acid as Extended Adjuvant Treatment of Postmenopausal Patients With Primary Breast Cancer

NCT ID: NCT00332709

Last Updated: 2011-11-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 83 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-01-31
• Study Completion Date: 2010-08-31

Brief Summary

This was a prospective, randomized, open-label, two arm phase III trial designed to evaluate the efficacy and safety of zoledronic acid in preventing bone loss in postmenopausal women with operable breast cancer who had received 4 to 6 years of adjuvant tamoxifen therapy after resection of the tumor. Patients were treated with letrozole 2.5 mg orally per day or letrozole 2.5 mg orally per day in combination with zoledronic acid 4 mg/6 months as an infusion.

This trial did not recruit patients in the United States.

Conditions

Osteoporosis; Postmenopausal

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Letrozole

Letrozole orally 2.5 mg/day for 3 years

Group Type: EXPERIMENTAL

Letrozole

Intervention Type: DRUG

2.5 mg/day for 3 years

Letrozole + Zoledronic Acid

Letrozole orally 2.5mg/day for 3 years; Zoledronic acid 4mg every 6 months by infusion

Group Type: EXPERIMENTAL

Letrozole

Intervention Type: DRUG

2.5 mg/day for 3 years

Zoledronic acid

Intervention Type: DRUG

4 mg every 6 months

Interventions

Letrozole

2.5 mg/day for 3 years

Intervention Type: DRUG

Zoledronic acid

4 mg every 6 months

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Compliant postmenopausal women with primary operable breast cancer after 4 to 6 years of therapy with tamoxifen (end of tamoxifen therapy within last 6 months)
• Performance status 0-2 (Eastern Cooperative Oncology Group)
• Patients without severe osteoporosis at study entry
• No evidence of relapse at the time of randomization
• Adequate function of bone marrow, kidney, and liver

Exclusion Criteria

• Estrogen- and progesterone-receptor status negative or unknown
• Completion of adjuvant tamoxifen therapy more than 6 months prior to study start
• Inflammatory breast cancer
• Current/active dental problems including infection of the teeth or jawbone, dental or fixture trauma, or a current or prior diagnosis of osteonecrosis of the jaw, of exposed bone in the mouth, or of slow healing after dental procedures.
• Recent (within 6 weeks) or planned dental or jaw surgery
• History of diseases with influence on bone metabolism such as Paget's disease and primary overactive parathyroid
• Prior or concomitant therapies: chemotherapy within the last 12 months, intravenous or oral bisphosphonates, systemic corticosteroids, anabolic steroids or growth hormones, Tibolone, parathyroid hormone, systemic sodium fluoride or any drugs known to affect the skeleton (such as calcitonin, mithramycin, or gallium nitrate)
• Patients with previous or concomitant cancers (not breast cancer) within the past 5 years EXCEPT adequately treated basal or squamous cell skin cancers or in situ cancer of the cervix. Patients with previous other cancer(s) must have been disease-free for at least 5 years.
• Patients currently receiving oral bisphosphonates must discontinue these at least 3 weeks prior to study start.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Novartis

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Locations

Novartis Investigative Site

Cologne, , Germany

Novartis Investigative Site

Deggendorf, , Germany

Novartis Investigative Site

Frankfurt am Main, , Germany

Novartis Investigative Site

Freiburg im Breisgau, , Germany

Novartis Investigative Site

Georgsmarienhütte, , Germany

Novartis Investigative Site

Göttingen, , Germany

Novartis Investigative Site

Halle, , Germany

Novaertis Investigative Site

Hamein, , Germany

Novartis Investigative Site

Hanover, , Germany

Novartis Investigative Site

Höxter, , Germany

Novartis Investigative Site

Ilsede, , Germany

Novartis Investigative Site

Jena, , Germany

Novartis Investigative Site

Karlsruhe, , Germany

Novartis Investigative Site

Leer, , Germany

Novartis Investigative Site

Lübeck, , Germany

Novartis Investigative Site

Mannheim, , Germany

Novartis Investigative Site

Münster, , Germany

Novartis Investigative Site

Rostock, , Germany

Novartis Investigative Site

Salzgitter, , Germany

Novartis Investigative Site

Schwenningen, , Germany

Novartis Investigative Site

Stendal, , Germany

Novartis Investigative Site

Völklingen, , Germany

Novartis Investigative Site

Witten, , Germany

Countries

Germany

References

Adams A, Jakob T, Huth A, Monsef I, Ernst M, Kopp M, Caro-Valenzuela J, Wockel A, Skoetz N. Bone-modifying agents for reducing bone loss in women with early and locally advanced breast cancer: a network meta-analysis. Cochrane Database Syst Rev. 2024 Jul 9;7(7):CD013451. doi: 10.1002/14651858.CD013451.pub2.

Reference Type: DERIVED

PMID: 38979716 (View on PubMed)

Other Identifiers

CFEM345DDE09

Identifier Type: -

Identifier Source: org_study_id