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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 is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
NSABP Foundation Inc
Information provided by (Responsible Party):
International Breast Cancer Study Group
ClinicalTrials.gov Identifier:
NCT00074152
First received: December 10, 2003
Last updated: July 29, 2016
Last verified: July 2016
Results First Received: April 7, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: 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
No text entered.

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
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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.
No text entered.

Reporting Groups
  Description
Arm I

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

radiation therapy: Given within 6 months after surgery

Arm II

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.

Total Total of all reporting groups

Baseline Measures
   Arm I   Arm II   Total 
Overall Participants Analyzed 
[Units: Participants]
 77   85   162 
Age 
[Units: Participants]
     
<=18 years   0   0   0 
Between 18 and 65 years   60   71   131 
>=65 years   17   14   31 
Gender 
[Units: Participants]
     
Female   77   85   162 
Male   0   0   0 
Region of Enrollment 
[Units: Participants]
     
United States   19   23   42 
Hungary   17   16   33 
Canada   15   16   31 
Spain   9   11   20 
Peru   1   0   1 
Australia   1   1   2 
South Africa   3   2   5 
Netherlands   6   6   12 
Switzerland   6   10   16 
Prior chemotherapy 
[Units: Participants]
     
Yes   52   49   101 
No   25   36   61 
Surgery for primary tumor 
[Units: Participants]
     
Mastectomy   31   33   64 
Breast conserving   46   52   98 
Estrogen receptor (ER) status of the isolated local or regional recurrence 
[Units: Participants]
     
Positive   48   56   104 
Negative   29   29   58 
Progesterone receptor (PgR) status of the isolated local or regional recurrence 
[Units: Participants]
     
positive   35   44   79 
negative   40   39   79 
not available   2   2   4 
Location of isolated loco-regional recurrence (ILRR) 
[Units: Participants]
     
Breast   41   47   88 
Mx scar/chest wall   26   27   53 
Regional lymph nodes   10   11   21 
Menopausal Status at isolated loco-regional recurrence (ILRR) 
[Units: Participants]
     
pre   14   20   34 
post   63   65   128 
Time from primary surgery to isolated loco-regional recurrence (ILRR) surgery 
[Units: Years]
Median (Full Range)
 6.2 
 (2.9 to 11.3) 
 5.0 
 (2.9 to 9.5) 
 5.5 
 (2.9 to 11.3) 
Estrogen receptor (ER) status of primary tumor 
[Units: Participants]
     
negative   20   27   47 
positive   47   49   96 
unknown   10   9   19 


  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
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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 )
Study First Received: December 10, 2003
Results First Received: April 7, 2015
Last Updated: July 29, 2016
Health Authority: United States: Federal Government
Switzerland: Swissmedic
United Kingdom: Medicines and Healthcare Products Regulatory Agency
Spain: Agencia Española de Medicamentos y Productos Sanitarios
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Netherlands: Medicines Evaluation Board (MEB)
Hungary: National Institute of Pharmacy
Belgium: Federal Agency for Medicinal Products and Health Products