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An Open-Label, Randomized, Multicenter Study to Evaluate the Use of Zoledronic Acid in the Prevention of Cancer Treatment-Related Bone Loss in Postmenopausal Women With Estrogen Receptor Positive and/or Progesterone Receptor Positive Breast Cancer Receiving Letrozole as Adjuvant Therapy


Phase 3
18 Years
85 Years
Not Enrolling
Female
Breast Neoplasms, Osteoporosis

Thank you

Trial Information

An Open-Label, Randomized, Multicenter Study to Evaluate the Use of Zoledronic Acid in the Prevention of Cancer Treatment-Related Bone Loss in Postmenopausal Women With Estrogen Receptor Positive and/or Progesterone Receptor Positive Breast Cancer Receiving Letrozole as Adjuvant Therapy


Inclusion Criteria:



1. Signed informed consent

2. Postmenopausal status defined by one of the following :

- women equal to or greater than 55 years with cessation of menses

- spontaneous cessation of menses within the past 1 year, but amenorrheic in women
less than or equal to 55 years (e.g., spontaneous or secondary to
hysterectomy), and with postmenopausal gonadotrophin levels (follicle
stimulating hormone levels >40 IU/L) or postmenopausal estradiol levels (< 5
ng/dL) or according to the definition of "postmenopausal range" for the
laboratory involved

- bilateral oophorectomy (prior to the diagnosis of breast cancer).

3. Adequately diagnosed and treated breast cancer defined as:

- Patients with breast cancer whose tumor can be removed by an appropriate
surgical procedure such as mastectomy or breast conserving surgery and who
receive appropriate additional local treatments such as radiotherapy according
to best practice.

- Patients must be at the end of their local treatment without evidence of local
residual disease.

- Patients must have no clinical or radiological evidence of distant metastasis.

4. Hormone receptor positive defined as:

- ER and/or PR greater than or equal to1 0 fmol/mg cytosol protein; or greater
than or equal to 10% of the tumor cells positive by

- immunohistochemical evaluation.

5. Patients with a baseline lumbar spine and total hip BMD T-score at or above -2.0 SD
are eligible.

6. Patients who will receive adjuvant chemotherapy are eligible for participation.
Adjuvant chemotherapy must be completed prior to randomization.

7. The date of randomization must not be more than the following:

- 12 weeks from completion of surgery;

- 12 weeks after completion of adjuvant chemotherapy;

- 12 weeks after completion of surgery and radiation therapy; however the patient
may be randomized while receiving radiation therapy - this decision is at the
Investigator's discretion.

- 12 weeks after completion of chemotherapy and radiation therapy; however, the
patient may be randomized while receiving radiation therapy - this decision is
at the Investigator's discretion.

8. Patients who have undergone neoadjuvant chemotherapy are eligible.

9. No prior treatment with Femara.

Exclusion criteria:

1. Patients with any clinical or radiological evidence of distant spread of their
disease at any point before randomization.

2. Patients with clinical or radiological evidence of existing fracture in the lumbar
spine and/or total hip.

3. Patients with a history of fracture with low-intensity or no associated trauma.

4. Patients who have started adjuvant hormonal therapy or who have completed adjuvant
hormonal therapy prior to randomization.

5. Patients who have received any endocrine therapy within the past 12 months (other
than neoadjuvant tamoxifen or toremifene, insulin and/or oral anti-diabetic
medications, and thyroid hormone replacement). Hormone replacement therapy must be
discontinued prior to randomization.

6. Patients who have received prior treatment with intravenous bisphosphonates within
the past 12 months.

7. Patients currently receiving oral bisphosphonates. Oral bisphosphonates must be
discontinued within 3 weeks of baseline evaluations.

8. Patients who have received prior treatment with systemic corticosteroids within the
past 12 months (short term corticosteroid therapy, e.g. to prevent/treat
chemotherapy-induced nausea/vomiting, is acceptable).

9. Patients with prior exposure to anabolic steroids or growth hormone within the past 6
months.

10. Patients with prior use of Tibolone within the last 6 months.

11. Any prior use of PTH for more than 1 week.

12. Prior use of systemic sodium fluoride for > 3 months during the past 2 years.

13. Patients currently treated with any drugs known to affect the skeleton (e.g.,
calcitonin, mithramycin, or gallium nitrate) within 2 weeks prior to randomization.

14. Patients with previous or concomitant malignancy (not breast cancer) within the past
5 years EXCEPT adequately treated basal or squamous cell carcinoma of the skin or in
situ carcinoma of the cervix. Patients who have had a previous other malignancy must
have been disease free for five years.

15. Patients with other non-malignant systemic diseases including uncontrolled
infections, uncontrolled type 2 diabetes mellitus, uncontrolled thyroid dysfunction,
cardiovascular, renal, hepatic, and lung diseases which would prevent prolonged
follow-up. Patients with previous history of thrombosis or thromboembolism can be
included only if medically suitable. Patients with a known history of HIV are
excluded.

16. Uncontrolled seizure disorders associated with falls.

17. Patients with abnormal renal function as evidenced by a serum creatinine equal to or
greater than 3 mg/dL (265.2 mmol/L).

18. History of diseases with influence on bone metabolism, such as Paget's disease,
Osteogenesis Imperfecta, and primary or secondary hyperthyroidism within 12 months
prior to study entry.

19. Patients with baseline lumber spine or total hip BMD T-score below -2.0 SD.

20. Patients treated with systemic investigational drug(s) and/or device(s) within the
past 30 days or topical investigational drugs within the past 7 days.

Additional Exclusion Criteria: (for Spine DXA)

- History of surgery at the lumbosacral spine, with or without implantable devices.

- Scoliosis with a Cobb angle >15 degree at the lumbar spine.

- Immobility, hyperostosis or sclerotic changes at the lumbar spine, or evidence of
sclerotic abdominal aorta sufficient to interfere with DXA scan.

- Any disease of the spine that would preclude the proper acquisition of a lumbar spine
DXA.

Additional protocol-defined inclusion/exclusion criteria may apply.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Outcome Measure:

Percent change in lumbar spine (L1-L4) bone mineral density (BMD) at 2 years, 3 years and 5 years

Outcome Time Frame:

2 years, 3 years & 5 years

Safety Issue:

No

Principal Investigator

Novartis Pharmaceuticals, MD

Investigator Role:

Study Director

Investigator Affiliation:

Novartis Pharmaceuticals

Authority:

United States: Food and Drug Administration

Study ID:

CZOL446EUS32

NCT ID:

NCT00050011

Start Date:

September 2002

Completion Date:

January 2009

Related Keywords:

  • Breast Neoplasms
  • Osteoporosis
  • cancer-treatment related bone loss
  • postmenopausal women
  • breast cancer
  • hormone receptor positive breast cancer
  • adjuvant therapy
  • hormonal therapy
  • bone loss
  • bisphosphonates
  • ZFAST
  • Letrozole
  • Zoledronic Acid
  • US32
  • Breast Neoplasms
  • Neoplasms
  • Osteoporosis

Name

Location

St. Joseph Regional Cancer CenterBryan, Texas  77802
Swedish Cancer InstituteSeattle, Washington  98104
Ocala Oncology CenterOcala, Florida  34474
Pacific Shores Medical GroupLong Beach, California  90813
Highlands Oncology GroupSpringdale, Arkansas  72764
Frederick Memorial Hospital Regional Cancer Therapy CenterFrederick, Maryland  21701
Cancer Research Network, Inc.Plantation, Florida  33324
Northern Virginia Oncology GroupFairfax, Virginia  22031
Elmhurst Memorial HospitalElmhurst, Illinois  60126
Kentuckiana Cancer InstituteLouisville, Kentucky  40202
Metro Minnesota CCOPSt. Louis Park, Minnesota  55416
The Sarah Cannon Cancer CenterNashville, Tennessee  37203
Oncology Hematology Group of South FloridaMiami, Florida  33176
Odyssey Research ServicesBismarck, North Dakota  58501
Charleston Hematology OncologyCharleston, South Carolina  29403
Wilshire Oncology Medical GroupGlendora, California  91741
East Valley Hematology & OncologyBurbank, California  91505
Louisiana Oncology AssociatesLafayette, California  70506
Clinical Trials & Research Associates, Inc.Montebello, California  90640
Redwood Regional Medical GroupSanta Rosa, California  95403
Cancer and Blood Institute of the DesertRancho Mirage, Colorado  92270
Eastern Connecticut Hematology/Oncology AssociatesNorwich, Connecticut  06360
FL Community Cancer CenterBrooksville, Florida  34613
Robert R. Carroll, MD, PAGainesville, Florida  32605
Pasco Pinellas Cancer CenterNew Port Richey, Florida  34652
Bay Area OncologyTampa, Florida  33607
Space Coast MedicalTitusville, Florida  32796
New England Hematology/Oncology AssociatesWellesley, Massachusetts  02481
Cook Research Department at Spectrum HealthGrand Rapids, Michigan  49503
Hematology-Oncology Centers of the Northern Rockies, PCBillings, Montana  59101
Methodist Cancer CenterOmaha, Nebraska  68114
Hematology-Oncology Associates of Northern NJMorristown, New Jersey  07962
New Mexico Oncology Hematology, Ltd.Albuquerque, New Mexico  87109
Hemoncare PCBrooklyn, New York  11235
Nashat Y. Gabrail MD Inc.Canton, Ohio  44718
Physician Associates, Inc.Cincinnati, Ohio  45238
Oncology Partners NetworkCincinnati, Ohio  45238
Dayton Clinical Oncology ProgramDayton, Ohio  45420
University of Pittsburgh Cancer Institute/Magee Womens HospitalPittsburgh, Pennsylvania  15213
Cancer Specialists of South TexasCorpus Christi, Texas  78412
Center for Oncology Research & Tx. PADallas, Texas  75230
Virginia Physicians, Inc.- OncologyRichmond, Virginia  23294
Rockwood Clinic, PSSpokane, Washington  99220