Pilot Study to Evaluate the Effect of Zoledronic Acid (Zometa) on Occult Malignant Bone Marrow Cells in Patients With High Risk Early Stage Breast Cancer
18 Years
N/A
Female
Breast Cancer
Trial Information
Pilot Study to Evaluate the Effect of Zoledronic Acid (Zometa) on Occult Malignant Bone Marrow Cells in Patients With High Risk Early Stage Breast Cancer
OBJECTIVES:
Primary
- Determine the response of bone marrow micrometastases, as measured by
immunocytochemistry/flow cytometry (IC/FC), during and after 2 years of treatment with
zoledronate in women with stage I-III breast cancer.
Secondary
- Evaluate the effects of zoledronate on the bone osteoclast activation marker,
n-telopeptide, in these patients.
- Evaluate the incidence of distant recurrences in high-risk women with early-stage
breast cancer and bone marrow micrometastases who receive adjuvant zoledronate.
OUTLINE: This is a pilot study.
Patients receive zoledronate IV over 15 minutes once a month for 2 years in the absence of
disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed every 6 months.
PROJECTED ACCRUAL: A total of 35 patients will be accrued for this study.
Inclusion Criteria
DISEASE CHARACTERISTICS:
- Histologically confirmed stage I-III breast cancer
- Bone marrow aspirate positive (by immunocytochemistry/flow cytometry [IC/FC] assay)
after diagnosis OR prior adjuvant chemotherapy*
- More than 4 micrometastases/mL NOTE: *If patient received adjuvant chemotherapy,
it must have been completed before start of study treatment
- Hormone receptor status not specified
PATIENT CHARACTERISTICS:
- Female
- Menopausal status not specified
- Karnofsky performance status ≥ 90%
- Creatinine normal
- Creatinine clearance ≥ 50 mL/min
- Total bilirubin, alkaline phosphatase, and AST normal
- No history of allergy to bisphosphonates
- Acute phase reaction is not considered an allergic reaction
- No history of renal insufficiency
- No significant medical condition that may interfere with study treatment
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- Prior surgery after neoadjuvant chemotherapy or hormonal therapy allowed
- No other concurrent bisphosphonate therapy, including oral bisphosphonates
- No concurrent cytotoxic anticancer therapy
- No other concurrent investigational drugs
- Concurrent hormonal therapy or radiotherapy allowed
Type of Study:
Interventional
Study Design:
Intervention Model: Single Group Assignment, Masking: Open Label
Outcome Measure:
Response of bone marrow micrometastases
Outcome Time Frame:
up to 2 years post initiation of treatment
Safety Issue:
No
Principal Investigator
Hope S. Rugo, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
University of California, San Francisco
Authority:
United States: Federal Government
Study ID:
CDR0000465216
NCT ID:
NCT00295867
Start Date:
December 2005
Completion Date:
December 2013
Related Keywords:
- Breast Cancer
- stage I breast cancer
- stage II breast cancer
- stage IIIA breast cancer
- stage IIIB breast cancer
- stage IIIC breast cancer
- Breast Neoplasms
Name | Location |
|---|---|
| UCSF Helen Diller Family Comprehensive Cancer Center | San Francisco, California 94115 |
