Zoledronate in Treating Bone Marrow Micrometastases in Women With Stage I, Stage II, or Stage III Breast Cancer
Information source: National Cancer Institute (NCI)
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Breast Cancer
Intervention: zoledronic acid (Drug)
Phase: Phase 2
Status: Active, not recruiting
Sponsored by: UCSF Helen Diller Family Comprehensive Cancer Center
Official(s) and/or principal investigator(s):
Hope S. Rugo, MD, Principal Investigator, Affiliation: UCSF Helen Diller Family Comprehensive Cancer Center
RATIONALE: Zoledronate may delay or prevent bone marrow metastases in patients with breast
PURPOSE: This phase II trial is studying how well zoledronate works in treating bone marrow
micrometastases in women with stage I, stage II, or stage III breast cancer.
Official title: 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
Study design: Treatment
Primary outcome: Response of bone marrow micrometastases
Effects of zoledronic acid on n-telopeptide
Incidence of distant recurrence
- 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.
- 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.
Minimum age: 18 Years.
Maximum age: N/A.
- 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
- 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
Locations and Contacts
UCSF Helen Diller Family Comprehensive Cancer Center, San Francisco, California 94115-1710, United States
Clinical trial summary from the National Cancer Institute's PDQ® database
Starting date: December 2005
Last updated: May 23, 2008