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Phase III Trial of Intravenous Zoledronic Acid (Zometa) in the Prevention of Bone Loss in Localized Breast Cancer Patients With Chemotherapy-Induced Ovarian Failure

Phase 3
40 Years
Not Enrolling
Breast Cancer, Osteoporosis

Thank you

Trial Information

Phase III Trial of Intravenous Zoledronic Acid (Zometa) in the Prevention of Bone Loss in Localized Breast Cancer Patients With Chemotherapy-Induced Ovarian Failure


- Compare the bone mineral density in the lumbar spine after 12 and 36 months of therapy
with zoledronate, calcium, and cholecalciferol (vitamin D) in women with breast cancer
receiving adjuvant chemotherapy.

OUTLINE: This is a randomized, open-label, multicenter study. Patients are stratified
according to intent to treat with tamoxifen (yes vs no) and node status (negative vs
positive vs unknown [for patients receiving neoadjuvant therapy]). Patients are randomized
to 1 of 2 treatment arms.

- Arm I: Beginning on the first day of adjuvant chemotherapy (or within 3 months after
the first day), patients receive zoledronate IV over at least 15 minutes once every 3
months during months 1-24 and oral calcium and oral cholecalciferol (vitamin D) daily
during months 1-36.

- Arm II: Beginning on the first day of adjuvant chemotherapy (or within 3 months after
the first day), patients receive oral calcium and oral vitamin D daily during months
1-36 and zoledronate IV over at least 15 minutes once every 3 months during months

PROJECTED ACCRUAL: Approximately 400 patients (200 per treatment arm) will be accrued for
this study within 24 months.

Inclusion Criteria


- Histologically confirmed adenocarcinoma of the breast by fine needle aspirate, biopsy
(tru-cut, core, stereotactic), lumpectomy, or modified radical mastectomy

- Stage I-III (any T, any N, M0)

- Stage IV due solely to supraclavicular node involvement allowed

- Plan to use adjuvant chemotherapy* with or without adjuvant endocrine therapy*

- Subsequent adjuvant hormonal therapy with an aromatase inhibitor allowed in
women rendered postmenopausal by adjuvant chemotherapy NOTE: *Must be specified
prior to study entry

- Hormone receptor status:

- Not specified



- 40 and over


- Female

Menopausal status:

- See Disease Characteristics

- Premenopausal, defined as actively menstruating or last menstrual period occurred
within 6 months prior to study entry

- Prior hysterectomy without bilateral oophorectomy and estradiol and
follicle-stimulating hormone within premenopausal range prior to the initiation
of chemotherapy allowed

Performance status:

- Not specified

Life expectancy:

- Not specified


- Not specified


- Not specified


- Not specified


- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception


Biologic therapy:

- Not specified


- See Disease Characteristics

- No more than 3 months since prior adjuvant chemotherapy

Endocrine therapy:

- See Disease Characteristics


- Not specified


- See Disease Characteristics

- See Menopausal status


- No other concurrent bisphosphonates

- No concurrent digoxin

- No concurrent tetracycline

- Concurrent neoadjuvant therapy allowed

- Concurrent enrollment on therapeutic adjuvant clinical trials allowed provided the
therapeutic trial does not preclude participation in this trial

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Outcome Measure:

Bone mineral density in the lumbar spine

Outcome Time Frame:

12 months from randomization

Safety Issue:


Principal Investigator

Charles L. Shapiro, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Ohio State University Comprehensive Cancer Center


United States: Food and Drug Administration

Study ID:




Start Date:

December 2001

Completion Date:

February 2009

Related Keywords:

  • Breast Cancer
  • Osteoporosis
  • osteoporosis
  • stage I breast cancer
  • stage II breast cancer
  • stage IV breast cancer
  • stage IIIA breast cancer
  • stage IIIB breast cancer
  • stage IIIC breast cancer
  • Breast Neoplasms
  • Osteoporosis



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