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

Information source: Novartis
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Osteoporosis; Postmenopausal

Intervention: Letrozole (Drug); Zoledronic acid (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Novartis

Official(s) and/or principal investigator(s):
Novartis Pharmaceuticals, Study Director, Affiliation: Novartis Pharmaceuticals

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.

Clinical Details

Official title: An Open Phase III Trial With Letrozole Alone or in Combination With Zoledronic Acid as Extended Adjuvant Treatment of Postmenopausal Patients With Primary Breast Cancer

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome:

Change in Bone Mineral Density (BMD) From Baseline to Month 36

Percent Change in Bone Mineral Density (BMD) From Baseline to Month 36

Change in T-score From Baseline to Month 36

Change in Z Score From Baseline to Month 36

Secondary outcome:

Change in Bone Mineral Density From Baseline to 12 Months

Number of Participants With Any Kind of Fractures, by Visit.

Median Disease Free Survival (DFS)

Change in T-Score From Baseline to Month 12

Change in Z-Score From Baseline to Month 12

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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. Additional protocol defined inclusion/exclusion criteria may apply.

Locations and Contacts

Novartis Investigative Site, Deggendorf, Germany

Novartis Investigative Site, Frankfurt/Main, Germany

Novartis Investigative Site, Freiburg, Germany

Novartis Investigative Site, Georgsmarienhutte, Germany

Novartis Investigative Site, Gottingen, Germany

Novartis Investigative Site, Halle, Germany

Novaertis Investigative Site, Hamein, Germany

Novartis Investigative Site, Hannover, Germany

Novartis Investigative Site, Hoxter, Germany

Novartis Investigative Site, Ilsede, Germany

Novartis Investigative Site, Jena, Germany

Novartis Investigative Site, Karlsruhe, Germany

Novartis Investigative Site, Koln, Germany

Novartis Investigative Site, Leer, Germany

Novartis Investigative Site, Lubeck, Germany

Novartis Investigative Site, Mannheim, Germany

Novartis Investigative Site, Munster, Germany

Novartis Investigative Site, Rostock, Germany

Novartis Investigative Site, Salzgitter, Germany

Novartis Investigative Site, Schwenningen, Germany

Novartis Investigative Site, Stendal, Germany

Novartis Investigative Site, Volklingen, Germany

Novartis Investigative Site, Witten, Germany

Additional Information

Starting date: January 2006
Last updated: October 10, 2011

Page last updated: August 23, 2015

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