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
Summary
RATIONALE: Zoledronate may delay or prevent bone marrow metastases in patients with breast
cancer.
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.
Clinical Details
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
Secondary outcome: Effects of zoledronic acid on n-telopeptideIncidence of distant recurrence
Detailed description:
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.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Female.
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
Locations and Contacts
UCSF Helen Diller Family Comprehensive Cancer Center, San Francisco, California 94115-1710, United States
Additional Information
Clinical trial summary from the National Cancer Institute's PDQ® database
Starting date: December 2005
Last updated: May 23, 2008
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