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A Randomized, Placebo Controlled Trial Of Zoledronic Acid For The Prevention Of Bone Loss In Premenopausal Women With Early Stage Breast Cancer


Phase 3
18 Years
50 Years
Open (Enrolling)
Female
Breast Cancer, Osteoporosis

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Trial Information

A Randomized, Placebo Controlled Trial Of Zoledronic Acid For The Prevention Of Bone Loss In Premenopausal Women With Early Stage Breast Cancer


OBJECTIVES:

- Compare the changes in bone mineral density (BMD) and bone turnover that occur in
premenopausal women with resected early stage breast cancer during and after 6 months
of adjuvant chemotherapy.

- Determine the factors that predict bone loss during chemotherapy, particularly
induction of amenorrhea, type of chemotherapeutic regimen, glucocorticoid exposure, and
baseline BMD, in these patients.

- Determine whether zoledronate prevents bone loss in these patients when given during
and after adjuvant chemotherapy.

- Determine the effect of zoledronate on markers of bone turnover in these patients
during and after adjuvant chemotherapy.

- Determine whether the effect on markers of bone turnover predicts response to
zoledronate in these patients.

OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients
are stratified according to estrogen receptor status (positive vs negative), progesterone
receptor status (positive vs negative), and adjuvant chemotherapy regimen. Patients are
randomized to 1 of 2 treatment arms.

- Arm I: Patients receive zoledronate IV over 15 minutes on day 1.

- Arm II: Patients receive placebo IV over 15 minutes on day 1. In both arms, treatment
repeats every 3 months for up to 4 courses in the absence of disease progression.
Patients also receive calcium and cholecalciferol (vitamin D) supplements daily.

Quality of life is assessed at baseline and at 6 and 12 months.

Patients are followed at 1 year.

PROJECTED ACCRUAL: A total of 120 patients (60 per treatment arm) will be accrued for this
study.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Diagnosis of localized breast cancer

- Stage I or II (T1-3, N0-2, M0)

- Planned adjuvant chemotherapy (after surgery) of at least 6 months in duration

- Hormone receptor status:

- Estrogen receptor and progesterone receptor status known

PATIENT CHARACTERISTICS:

Age

- 18 to 50

Sex

- Female

Menopausal status

- Premenopausal or perimenopausal

Performance status

- Not specified

Life expectancy

- Not specified

Hematopoietic

- Not specified

Hepatic

- Not specified

Renal

- Creatinine less than 2 mg/dL

Other

- No T score of less than 2.0 on bone mineral density (BMD)

- No fragility fracture

- No lumbar spine anatomy that would preclude accurate BMD measurement of a minimum of
3 lumbar vertebrae

- Not pregnant

PRIOR CONCURRENT THERAPY:

Biologic therapy

- Not specified

Chemotherapy

- See Disease Characteristics

Endocrine therapy

- Not specified

Radiotherapy

- No concurrent radiotherapy

Surgery

- See Disease Characteristics

Other

- At least 1 month since prior calcitonin

- At least 12 months since prior bisphosphonates given for more than 1 month duration

- No concurrent fluoride therapy (10 mg/day or more)

- No concurrent enrollment in another experimental drug study

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Masking: Double-Blind, Primary Purpose: Supportive Care

Outcome Measure:

Changes in lumbar spine bone mineral density (BMD) at 6 months

Principal Investigator

Dawn Hershman, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Herbert Irving Comprehensive Cancer Center

Authority:

United States: Federal Government

Study ID:

CDR0000258105

NCT ID:

NCT00049452

Start Date:

December 2001

Completion Date:

Related Keywords:

  • Breast Cancer
  • Osteoporosis
  • osteoporosis
  • stage I breast cancer
  • stage II breast cancer
  • Breast Neoplasms
  • Osteoporosis

Name

Location

Herbert Irving Comprehensive Cancer Center at Columbia UniversityNew York, New York  10032
Carl and Dorothy Bennett Cancer Center at Stamford HospitalStamford, Connecticut  06904
Valley Hospital - ParamusParamus, New Jersey  07652-2509