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S0307 Phase III Trial of Bisphosphonates as Adjuvant Therapy for Primary Breast Cancer.

NCT00127205 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 6097

Last updated 2021-07-02

Study results available
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Summary

RATIONALE: Zoledronate, clodronate, or ibandronate may delay or prevent bone metastases in patients with nonmetastatic breast cancer. It is not yet known whether zoledronate is more effective than clodronate or ibandronate in treating breast cancer.

PURPOSE: This randomized phase III trial is studying zoledronate to see how well it works compared to clodronate or ibandronate in treating women who have undergone surgery for stage I, stage II, or stage III breast cancer.

Conditions

Interventions

DRUG

clodronate disodium

Given orally

DRUG

ibandronate sodium

Given orally

DRUG

zoledronic acid

Given IV

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • North Central Cancer Treatment Group

    collaborator NETWORK

  • Eastern Cooperative Oncology Group

    collaborator NETWORK

  • NSABP Foundation Inc

    collaborator NETWORK

  • Cancer and Leukemia Group B

    collaborator NETWORK

  • NCIC Clinical Trials Group

    collaborator NETWORK

  • SWOG Cancer Research Network

    lead NETWORK

Principal Investigators

  • Julie R. Gralow, MD · Seattle Cancer Care Alliance

  • Robert B. Livingston, MD · University of Arizona

  • James N. Ingle, MD · Mayo Clinic

  • Carla I. Falkson, MD · University of Alabama at Birmingham

  • Alexander H Paterson, MD, FRCP · Tom Baker Cancer Centre - Calgary

  • Elizabeth C. Dees, MD · UNC Lineberger Comprehensive Cancer Center

  • Mark J. Clemons, MD · Toronto Sunnybrook Regional Cancer Centre

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-07-31
Primary Completion
2017-12-31
Completion
2021-03-29

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00127205 on ClinicalTrials.gov