Zoledronate in Treating Bone Marrow Micrometastases in Women With Stage I, Stage II, or Stage III Breast Cancer

NCT00295867 | Completed Phase 2 Results DMC FDA Drug

• 3 other identifiers: 037519UCSF-H6961-24352-0210-01674
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Breast Cancer

Keywords

stage I breast cancer; stage II breast cancer; stage IIIA breast cancer; stage IIIB breast cancer; stage IIIC breast cancer

Outcome Measures

Primary Outcomes (1)

• Response of Bone Marrow Micrometastases

  Median change in disseminated tumor cells (DTCs)/mL from baseline after 24 months

  up to 2 years

Secondary Outcomes (2)

• Change in N-telopeptide Level

  up to 2 years

• Number of Patients With Incidences of Distant Recurrence

  up to 5 years post initiation of treatment

Study Arms (1)

Zoledronic Acid

EXPERIMENTAL

Patients women with early stage breast cancer and evidence of occult malignant cells in bone marrow aspirates following adjuvant chemotherapy will receive zoledronic acid (Zometa) 4mg, given intravenously over 15 minutes, once a month for two years.

Drug: Zoledronic Acid

Interventions

Zoledronic Acid DRUG

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

Also known as: Zometa, Zoledronate

Zoledronic Acid

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Women \> 18 years of age with histologically or cytologically confirmed stage I, II or III breast cancer.
• If adjuvant chemotherapy is recommended, it must be completed before study start.
• 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.
• Adequate renal function as defined by:
• a. Creatinine must be \< upper limit of normal
• Normal liver function tests including total bilirubin, alkaline phosphatase, and aspartate aminotransferase (AST) / serum glutamic-oxaloacetic transaminase (SGOT)
• Ability to understand and sign informed consent.
• Concomitant hormonal therapy is allowed
• Concomitant radiation therapy is allowed
• Patients who have had surgery following neoadjuvant chemotherapy or hormonal therapy are eligible to participate in this trial

You may not qualify if:

• 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.
• 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.
• Karnofsky Performance status \< 90%.
• Any significant medical condition that might interfere with treatment.
• Women participating in this study are not allowed to receive other bisphosphonate therapy during the study period, either oral or intravenous.
• Patients who are pregnant

Sponsors & Collaborators

• University of California, San Francisco: lead
• Novartis: collaborator

Study Sites (1)

University of California, San Francisco

San Francisco, California, 94115-1710, United States

Location

Related Publications (1)

• Adams A, Jakob T, Huth A, Monsef I, Ernst M, Kopp M, Caro-Valenzuela J, Wockel A, Skoetz N. Bone-modifying agents for reducing bone loss in women with early and locally advanced breast cancer: a network meta-analysis. Cochrane Database Syst Rev. 2024 Jul 9;7(7):CD013451. doi: 10.1002/14651858.CD013451.pub2.

  PMID: 38979716 DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Zoledronic Acid

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Diphosphonates; Organophosphonates; Organophosphorus Compounds; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Hope S. Rugo
• Organization: UCSF Helen Diller Family Comprehensive Cancer Center

hrugo@medicine.ucsf.edu

415-353-7618

Study Officials

• Hope S. Rugo, MD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 23, 2006
• First Posted: February 24, 2006
• Study Start: November 3, 2004
• Primary Completion: June 1, 2011
• Study Completion: December 1, 2013
• Last Updated: May 12, 2020
• Results First Posted: May 12, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)