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: April 24, 2015
Last verified: April 2015
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  
Number of Participants  
[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
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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, BIG-1-02, EU-20320, NSABP-B-37, 2005-001484-64
Study First Received: December 10, 2003
Results First Received: April 7, 2015
Last Updated: April 24, 2015
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