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:
University of California, San Francisco
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
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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:
Genetics Home Reference related topics:
breast cancer
Drug Information available for:
Zoledronic acid
U.S. FDA Resources
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
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 June 17, 2013