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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00009945
Recruitment Status : Completed
First Posted : January 27, 2003
Results First Posted : November 20, 2017
Last Update Posted : December 13, 2017
National Cancer Institute (NCI)
Southwest Oncology Group
North Central Cancer Treatment Group
Information provided by (Responsible Party):
NSABP Foundation Inc

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Breast Cancer
Interventions: Drug: clodronate
Drug: placebo

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
Arm 1: Clodronate

Patient receives 2 tablets once daily for 3 years.

clodronate: 1600 mg PO daily

Arm 2: Placebo

Patient receives 2 tablets once daily for 3 years.

placebo: 2 pills PO daily

Participant Flow:   Overall Study
    Arm 1: Clodronate   Arm 2: Placebo
STARTED   1662   1661 
COMPLETED   1655   1656 
no follow up data                7                5 

  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
Clodronate Clodronate
Placebo Placebo
Total Total of all reporting groups

Baseline Measures
   Clodronate   Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 1662   1661   3323 
[Units: Years]
Mean (Standard Deviation)
 54  (10.5)   53  (10.4)   54  (10.4) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
Female      1662 100.0%      1661 100.0%      3323 100.0% 
Male      0   0.0%      0   0.0%      0   0.0% 

  Outcome Measures

1.  Primary:   Disease Free Survival.   [ Time Frame: 8 years ]

2.  Secondary:   Skeletal Metastasis Free Survival   [ Time Frame: 8 years ]

3.  Secondary:   Overall Survival   [ Time Frame: 8 years ]

4.  Secondary:   Relapse Free Survival   [ Time Frame: 8 years ]

5.  Secondary:   Incidence of Non-skeletal Metastasis   [ Time Frame: 8 years ]

  Serious Adverse Events

  Other Adverse Events

  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.

Results Point of Contact:  
Name/Title: Director, Department of Regulatory Affairs
Organization: NSABP Foundation, Inc.
phone: 412-339-5300

Publications of Results:
Other Publications:
Publications automatically indexed to this study by Identifier (NCT Number):

Responsible Party: NSABP Foundation Inc Identifier: NCT00009945     History of Changes
Other Study ID Numbers: NSABP B-34
First Submitted: February 2, 2001
First Posted: January 27, 2003
Results First Submitted: October 17, 2017
Results First Posted: November 20, 2017
Last Update Posted: December 13, 2017