Zoledronate in Treating Bone Marrow Micrometastases in Women With Stage I, Stage II, or Stage III Breast Cancer
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Intervention: Zoledronic Acid
Intervention description: Zoledronic acid is a new, highly potent, heterocyclic nitrogen-containing third generation bisphosphonate that has demonstrated 40- to 850- fold greater potency than pamidronate in preclinical models of bone resorption. The mechanism of action of nitrogen-containing bisphosphonates such as pamidronate and zoledronic acid appears to involve inhibition of the mevalonate pathway
Intervention MeSH terms: Zoledronic Acid
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 45.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: stage I breast cancer; stage II breast cancer; stage IIIA breast cancer; stage IIIB breast cancer; stage IIIC breast cancer

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.
    

Eligibility criteria:

        Inclusion Criteria

          1. Women > 18 years of age with histologically or cytologically confirmed stage I, II or
             III breast cancer.

          2. If adjuvant chemotherapy is recommended, it must be completed before study start.

          3. Bone marrow aspirate positive by IC/FC assay

             a. Definition of positive: > 4 MM/ml b. Timing of bone marrow aspiration to determine
             study eligibility: i. If patient is to receive either no adjuvant therapy or hormonal
             therapy alone, the aspiration may be performed at diagnosis as part of the large MM
             study at University of California, San Francisco, or following diagnosis if the
             patient received initial surgery elsewhere. This is also true for patients who have
             surgery following neoadjuvant therapy for breast cancer.

             ii. If the patient is to receive adjuvant chemotherapy, the aspiration will be
             performed at least three weeks after chemotherapy has been completed.

          4. Adequate renal function as defined by:

             a. Creatinine must be < upper limit of normal

          5. Normal liver function tests including total bilirubin, alkaline phosphatase, and
             aspartate aminotransferase (AST) / serum glutamic-oxaloacetic transaminase (SGOT)

          6. Ability to understand and sign informed consent.

          7. Concomitant hormonal therapy is allowed

          8. Concomitant radiation therapy is allowed

          9. Patients who have had surgery following neoadjuvant chemotherapy or hormonal therapy
             are eligible to participate in this trial

        Exclusion Criteria

          1. History of allergy to bisphosphonates. Acute phase reactions occur in up to 24% of
             patients and disappear with subsequent dosing. An acute phase reaction does not
             qualify as an allergic reaction.

          2. History of renal insufficiency. Renal insufficiency is defined by a serum creatinine
             greater than the upper limit of normal or a creatinine clearance < 50 mL/min due to
             any underlying cause.

          3. Karnofsky Performance status < 90%.

          4. Any significant medical condition that might interfere with treatment.

          5. Women participating in this study are not allowed to receive other bisphosphonate
             therapy during the study period, either oral or intravenous.

          6. Patients who are pregnant