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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)

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ClinicalTrials.gov Identifier: NCT00074152
Recruitment Status : Completed
First Posted : December 11, 2003
Results First Posted : May 12, 2015
Last Update Posted : June 16, 2017
Sponsor:
Collaborator:
NSABP Foundation Inc
Information provided by (Responsible Party):
International Breast Cancer Study Group

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
Enrollment 162

Recruitment Details  
Pre-assignment Details  
Arm/Group Title Observation Chemotherapy
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Observation (+/- Radiation). Patients receive radiotherapy* within 6 months after surgery.

radiation therapy: Given within 6 months after surgery

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.

Period Title: Overall Study
Started 77 85
Completed 22 52
Not Completed 55 33
Reason Not Completed
Death             21             9
Lack of Efficacy             34             24
Arm/Group Title Arm I Arm II Total
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Observation (+/- Radiation). Patients receive radiotherapy* within 6 months after surgery.

radiation therapy: Given within 6 months after surgery

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 of all reporting groups
Overall Number of Baseline Participants 77 85 162
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 77 participants 85 participants 162 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
60
  77.9%
71
  83.5%
131
  80.9%
>=65 years
17
  22.1%
14
  16.5%
31
  19.1%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 77 participants 85 participants 162 participants
Female
77
 100.0%
85
 100.0%
162
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 77 participants 85 participants 162 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  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 77 participants 85 participants 162 participants
Yes 52 49 101
No 25 36 61
Surgery for primary tumor  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 77 participants 85 participants 162 participants
Mastectomy 31 33 64
Breast conserving 46 52 98
Estrogen receptor (ER) status of the isolated local or regional recurrence  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 77 participants 85 participants 162 participants
Positive 48 56 104
Negative 29 29 58
Progesterone receptor (PgR) status of the isolated local or regional recurrence  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 77 participants 85 participants 162 participants
positive 35 44 79
negative 40 39 79
not available 2 2 4
Location of isolated loco-regional recurrence (ILRR)  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 77 participants 85 participants 162 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)  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 77 participants 85 participants 162 participants
pre 14 20 34
post 63 65 128
Time from primary surgery to isolated loco-regional recurrence (ILRR) surgery  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 77 participants 85 participants 162 participants
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  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 77 participants 85 participants 162 participants
negative 20 27 47
positive 47 49 96
unknown 10 9 19
1.Primary Outcome
Title Disease-free Survival
Hide Description [Not Specified]
Time Frame 5 years after randomization
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm I Arm II
Hide Arm/Group Description:

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

radiation therapy: Given within 6 months after surgery

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.

Overall Number of Participants Analyzed 77 85
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
57
(44 to 67)
69
(56 to 79)
2.Secondary Outcome
Title Overall Survival
Hide Description [Not Specified]
Time Frame 5 years after randomization
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm I Arm II
Hide Arm/Group Description:

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

radiation therapy: Given within 6 months after surgery

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.

Overall Number of Participants Analyzed 77 85
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
76
(63 to 85)
88
(77 to 94)
3.Secondary Outcome
Title Sites of First Failures
Hide Description Tumor recurrence in the breast, lymph nodes or other areas of the body including bone, lung, liver, central nervous system, bone marrow
Time Frame 5 years after randomization
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm I Arm II
Hide Arm/Group Description:

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

radiation therapy: Given within 6 months after surgery

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.

Overall Number of Participants Analyzed 77 85
Measure Type: Number
Unit of Measure: participants
Failures 34 24
Deaths 21 9
Local or Regional 9 6
Distant 22 15
Soft Tissue 2 0
Bone 5 8
Viscera 15 7
Contralateral Breast 1 1
Secon (non-breast) Malignancy 0 1
Death without prior Cancer Event 0 1
Death, cause unknown 2 0
Time Frame From date patient provided informed consent until 4 weeks after study treatment completion, beyond 4 weeks after stopping study treatment any death or serious adverse event considered possibly related to previous study treatment (approximately 10 years)
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Arm I Arm II
Hide Arm/Group Description

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

radiation therapy: Given within 6 months after surgery

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.

All-Cause Mortality
Arm I Arm II
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Arm I Arm II
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/77 (0.00%)      12/85 (14.12%)    
Blood and lymphatic system disorders     
Neutropenia  1 [1]  0/77 (0.00%)  0 1/85 (1.18%)  1
Cardiac disorders     
Left ventricular dysfunction  1  0/77 (0.00%)  0 1/85 (1.18%)  1
Cardiac ischemia  1  0/77 (0.00%)  0 2/85 (2.35%)  2
Gastrointestinal disorders     
Gastrointestinal pain  1  0/77 (0.00%)  0 1/85 (1.18%)  1
Colitis  1  0/77 (0.00%)  0 1/85 (1.18%)  1
Infections and infestations     
Febrile neutropenia  1  0/77 (0.00%)  0 3/85 (3.53%)  3
Pulmonary/upper respiratory infection  1  0/77 (0.00%)  0 1/85 (1.18%)  1
Diverticulitis  1  0/77 (0.00%)  0 1/85 (1.18%)  1
Nervous system disorders     
Motor neuropathy  1  0/77 (0.00%)  0 1/85 (1.18%)  1
Reproductive system and breast disorders     
Endometrial mucosa thinkening  1  0/77 (0.00%)  0 1/85 (1.18%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (3.0)
[1]
Neutropenia with symptoms of generalized musculoskeletal pain and fatigue
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Arm I Arm II
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/77 (0.00%)      0/85 (0.00%)    
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
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