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
  Purpose

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 Intervention
Breast Cancer
Drug: zoledronic acid

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by University of California, San Francisco:

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

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 45
Study Start Date: December 2005
Estimated Study Completion Date: December 2013
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Zoledronic Acid Drug: zoledronic acid

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00295867

Locations
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
Investigators
Principal Investigator: Hope S. Rugo, MD University of California, San Francisco
  More Information

Additional Information:
No publications provided

Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT00295867     History of Changes
Other Study ID Numbers: CDR0000465216, UCSF-037519, UCSF-H6961-24352-02
Study First Received: February 23, 2006
Last Updated: October 9, 2012
Health Authority: United States: Federal Government
United States: Food and Drug Administration

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
Neoplasms
Breast Diseases
Skin Diseases
Zoledronic acid
Diphosphonates
Bone Density Conservation Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 26, 2014