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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


Phase 3
18 Years
N/A
Not Enrolling
Both
Osteoporosis, Postmenopausal

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Trial Information

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


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.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

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

Outcome Description:

Change in bone mineral density (BMD) measured by dual X-ray absorptiometry (DXA) in lumbar spine (L1-L4). Change calculated by (Month 36 BMD-Baseline BMD)/Baseline BMD*100.

Outcome Time Frame:

at 36 months as compared to baseline

Safety Issue:

No

Principal Investigator

Novartis Pharmaceuticals

Investigator Role:

Study Director

Investigator Affiliation:

Novartis Pharmaceuticals

Authority:

Germany: Federal Institute for Drugs and Medical Devices

Study ID:

CFEM345DDE09

NCT ID:

NCT00332709

Start Date:

January 2006

Completion Date:

August 2010

Related Keywords:

  • Osteoporosis
  • Postmenopausal
  • Breast cancer
  • postmenopausal
  • bone mineral density
  • Zoledronic acid
  • Letrozole
  • extended adjuvant treatment.
  • Postmenopausal women with primary hormone receptor positive breast cancer
  • Breast Neoplasms
  • Osteoporosis

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