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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


N/A
18 Years
N/A
Open (Enrolling)
Female
Breast Cancer

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Trial Information

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


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label

Outcome Measure:

Response of bone marrow micrometastases

Outcome Time Frame:

up to 2 years post initiation of treatment

Safety Issue:

No

Principal Investigator

Hope S. Rugo, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of California, San Francisco

Authority:

United States: Federal Government

Study ID:

CDR0000465216

NCT ID:

NCT00295867

Start Date:

December 2005

Completion Date:

December 2013

Related Keywords:

  • Breast Cancer
  • stage I breast cancer
  • stage II breast cancer
  • stage IIIA breast cancer
  • stage IIIB breast cancer
  • stage IIIC breast cancer
  • Breast Neoplasms

Name

Location

UCSF Helen Diller Family Comprehensive Cancer CenterSan Francisco, California  94115