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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00295867
Recruitment Status : Unknown
Verified October 2012 by University of California, San Francisco.
Recruitment status was:  Active, not recruiting
First Posted : February 24, 2006
Last Update Posted : October 10, 2012
National Cancer Institute (NCI)
Information provided by (Responsible Party):
University of California, San Francisco

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.

Condition or disease Intervention/treatment Phase
Breast Cancer Drug: zoledronic acid Not Applicable

Detailed Description:



  • 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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 45 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
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 Start Date : December 2005
Actual Primary Completion Date : June 2011
Estimated Study Completion Date : December 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
Experimental: Zoledronic Acid Drug: zoledronic acid

Primary Outcome Measures :
  1. Response of bone marrow micrometastases [ Time Frame: up to 2 years post initiation of treatment ]

Secondary Outcome Measures :
  1. Effects of zoledronic acid on n-telopeptide [ Time Frame: up to 2 years post initiation of treatment ]
  2. Incidence of distant recurrence [ Time Frame: up to 5 years post initiation of treatment ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No


  • 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


  • 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


  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00295867

United States, California
UCSF Helen Diller Family Comprehensive Cancer Center
San Francisco, California, United States, 94115-1710
Sponsors and Collaborators
University of California, San Francisco
National Cancer Institute (NCI)
Principal Investigator: Hope S. Rugo, MD University of California, San Francisco

Responsible Party: University of California, San Francisco Identifier: NCT00295867     History of Changes
Other Study ID Numbers: CDR0000465216
First Posted: February 24, 2006    Key Record Dates
Last Update Posted: October 10, 2012
Last Verified: October 2012

Keywords provided by University of California, San Francisco:
stage I breast cancer
stage II breast cancer
stage IIIA breast cancer
stage IIIB breast cancer
stage IIIC breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Zoledronic acid
Bone Density Conservation Agents
Physiological Effects of Drugs