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:
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

February 23, 2006
October 9, 2012
December 2005
June 2011   (final data collection date for primary outcome measure)
Response of bone marrow micrometastases [ Time Frame: up to 2 years post initiation of treatment ] [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00295867 on ClinicalTrials.gov Archive Site
  • 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 ]
Not Provided
Not Provided
Not Provided
 
Zoledronate in Treating Bone Marrow Micrometastases in Women With Stage I, Stage II, or Stage III Breast Cancer
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

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.

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.

Interventional
Not Provided
Intervention Model: Single Group Assignment
Masking: Open Label
Breast Cancer
Drug: zoledronic acid
Experimental: Zoledronic Acid
Intervention: Drug: zoledronic acid
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
45
December 2013
June 2011   (final data collection date for primary outcome measure)

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
Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00295867
CDR0000465216, UCSF-037519, UCSF-H6961-24352-02
Not Provided
University of California, San Francisco
University of California, San Francisco
National Cancer Institute (NCI)
Principal Investigator: Hope S. Rugo, MD University of California, San Francisco
University of California, San Francisco
October 2012

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