CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 6,097 enrolled
Drug / intervention
clodronate disodium +2 moredrug
Likely dose
Clodronate disodium orally; ibandronate sodium orally; or zoledronic acid IV (specific doses not stated)AI-extracted
Key inclusion· 6
  • Histologically confirmed primary adenocarcinoma of the breast, Stage I-III
  • Surgery (lumpectomy or mastectomy) within past 12 weeks OR completed chemotherapy within past 8 weeks
  • Currently receiving or planning to receive standard adjuvant systemic therapy (chemotherapy, hormonal therapy, or combined)
  • No evidence of metastatic disease (including negative bone scan/imaging if skeletal pain present)
Key exclusion· 6
  • Low-risk patients for whom adjuvant systemic therapy will not be prescribed
  • Patients receiving biologic agents only or local radiotherapy only (without chemotherapy and/or hormone therapy)
  • History of esophageal stricture or motility disorders
  • Other malignancy within past 5 years (except adequately treated skin cancer, cervical CIS, or Stage I-II cancer in complete remission)

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00127205
NCT00127205Phase 3Completed

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

SWOG Cancer Research Network·interventional·Posted Aug 5, 2005·Updated Jul 2, 2021

In Brief

A Phase 3 clinical trial evaluating clodronate disodium, ibandronate sodium, and 1 other intervention for Breast Cancer. Completed, enrolled 6,097 participants.

Detailed 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.

Study Details

Timeline

Phase 3CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedAug 5, 2005
Enrollment StartJul 1, 2005
Primary CompletionDec 1, 2017
Study CompletionMar 29, 2021
TodayJul 2, 2026
Enrollment to primary: 12.4 yearsPosted 20.9 years ago

Interventions

clodronate disodiumdrug

Given orally

ibandronate sodiumdrug

Given orally

zoledronic aciddrug

Given IV