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Adjuvant Chemotherapy in Treating Women Who Have Undergone Resection for Relapsed Breast Cancer; Chemotherapy as Adjuvant for LOcally Recurrent Breast Cancer (CALOR)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00074152
First Posted: December 11, 2003
Last Update Posted: June 16, 2017
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.
Collaborator:
NSABP Foundation Inc
Information provided by (Responsible Party):
International Breast Cancer Study Group
Results First Submitted: April 7, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Breast Cancer
Interventions: Drug: chemotherapy
Radiation: radiation therapy

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

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
  Description
Observation

Observation (+/- Radiation). Patients receive radiotherapy* within 6 months after surgery.

radiation therapy: Given within 6 months after surgery

Chemotherapy

Chemotherapy (+/- Radiation). Within 10 weeks after surgery, patients receive at least 3 courses of an adjuvant chemotherapy regimen as determined by the investigator. Patients may receive radiotherapy within 6 months after surgery and after the completion of chemotherapy OR integrated with chemotherapy.

chemotherapy: Given within 10 weeks after surgery.


Participant Flow:   Overall Study
    Observation   Chemotherapy
STARTED   77   85 
COMPLETED   22   52 
NOT COMPLETED   55   33 
Death                21                9 
Lack of Efficacy                34                24 



  Baseline Characteristics


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Disease-free Survival   [ Time Frame: 5 years after randomization ]

2.  Secondary:   Overall Survival   [ Time Frame: 5 years after randomization ]

3.  Secondary:   Sites of First Failures   [ Time Frame: 5 years after randomization ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide 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
Small sample size


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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.


Results Point of Contact:  
Name/Title: Barbara Ruepp
Organization: International Breast Cancer Study Goup
phone: +4131 3899222
e-mail: barbara.ruepp@ibcsg.org


Publications of Results:

Responsible Party: International Breast Cancer Study Group
ClinicalTrials.gov Identifier: NCT00074152     History of Changes
Other Study ID Numbers: CDR0000343619
IBCSG-27-02 ( Other Identifier: IBCSG )
BIG-1-02 ( Other Identifier: Breast International Group )
EU-20320
NSABP-B-37
2005-001484-64 ( EudraCT Number )
First Submitted: December 10, 2003
First Posted: December 11, 2003
Results First Submitted: April 7, 2015
Results First Posted: May 12, 2015
Last Update Posted: June 16, 2017