Zoledronate in Treating Bone Marrow Micrometastases in Women With Stage I, Stage II, or Stage III Breast Cancer

This study is ongoing, but not recruiting participants.

Sponsor:

Collaborator:

National Cancer Institute (NCI)

Information provided by (Responsible Party):

University of California, San Francisco

ClinicalTrials.gov Identifier:

NCT00295867

First received: February 23, 2006

Last updated: October 9, 2012

Last verified: October 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

February 23, 2006

Last Updated Date

October 9, 2012

Start Date ^ICMJE

December 2005

Primary Completion Date

June 2011 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Response of bone marrow micrometastases [ Time Frame: up to 2 years post initiation of treatment ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Not Provided

Change History

Complete list of historical versions of study NCT00295867 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Effects of zoledronic acid on n-telopeptide [ Time Frame: up to 2 years post initiation of treatment ] [ Designated as safety issue: No ]
Incidence of distant recurrence [ Time Frame: up to 5 years post initiation of treatment ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Zoledronate in Treating Bone Marrow Micrometastases in Women With Stage I, Stage II, or Stage III Breast Cancer

Official Title ^ICMJE

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

Brief 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.

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.

Study Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Intervention Model: Single Group Assignment
Masking: Open Label

Condition ^ICMJE

Breast Cancer

Intervention ^ICMJE

Drug: zoledronic acid

Study Arm (s)

Experimental: Zoledronic Acid

Intervention: Drug: zoledronic acid

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

December 2013

Primary Completion Date

June 2011 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Female

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00295867

Other Study ID Numbers ^ICMJE

CDR0000465216, UCSF-037519, UCSF-H6961-24352-02

Has Data Monitoring Committee

Not Provided

Responsible Party

University of California, San Francisco

Study Sponsor ^ICMJE

University of California, San Francisco

Collaborators ^ICMJE

National Cancer Institute (NCI)

Investigators ^ICMJE

Principal Investigator:

Hope S. Rugo, MD

University of California, San Francisco

Information Provided By

University of California, San Francisco

Verification Date

October 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

To Top