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Clodronate With or Without Chemotherapy and/or Hormonal Therapy in Treating Women With Stage I or Stage II Breast Cancer

NCT00009945 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 3323

Last updated 2017-12-13

Study results available
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Summary

RATIONALE: Clodronate may be effective in preventing the spread of cancer to the bones and other parts of the body. It is not yet known whether clodronate is more effective alone or combined with chemotherapy and /or hormonal therapy in preventing metastatic breast cancer.

PURPOSE: Randomized phase III trial to determine the effectiveness of clodronate with or without chemotherapy and /or hormonal therapy in preventing metastases in women who have stage I or stage II breast cancer.

Conditions

Interventions

DRUG

clodronate

1600 mg PO daily

DRUG

placebo

2 pills PO daily

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • SWOG Cancer Research Network

    collaborator NETWORK

  • North Central Cancer Treatment Group

    collaborator NETWORK

  • NSABP Foundation Inc

    lead NETWORK

Principal Investigators

  • Norman Wolmark, MD · NSABP Foundation Inc

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2001-01-31
Primary Completion
2011-03-31
Completion
2012-12-31

Countries

  • United States

Study Locations

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Entities

Drugs
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 NCT00009945 on ClinicalTrials.gov