Overview

This trial is active, not recruiting.

Condition breast cancer
Treatment zoledronic acid
Sponsor University of California, San Francisco
Collaborator National Cancer Institute (NCI)
Start date December 2005
End date June 2011
Trial size 45 participants
Trial identifier NCT00295867, CDR0000465216, UCSF-037519, UCSF-H6961-24352-02

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Intervention model single group assignment
Masking open label
Arm
(Experimental)
zoledronic acid

Primary Outcomes

Measure
Response of bone marrow micrometastases
time frame: up to 2 years post initiation of treatment

Secondary Outcomes

Measure
Effects of zoledronic acid on n-telopeptide
time frame: up to 2 years post initiation of treatment
Incidence of distant recurrence
time frame: up to 5 years post initiation of treatment

Eligibility Criteria

Female participants at least 18 years old.

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

Additional Information

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
Principal investigator Hope S. Rugo, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in October 2012.
Information provided to ClinicalTrials.gov by University of California, San Francisco.