Impact of Chemotherapy Followed by Aromatase Inhibitors on Bone Health of Women With ER-positive Early Breast Cancer (POCHARBI)
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ClinicalTrials.gov Identifier: NCT01298362 |
Recruitment Status :
Completed
First Posted : February 17, 2011
Results First Posted : September 20, 2016
Last Update Posted : September 20, 2016
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Sponsor:
Hellenic Breast Surgeons Society
Information provided by (Responsible Party):
Hellenic Breast Surgeons Society
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Study Type | Observational |
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Study Design | Observational Model: Cohort; Time Perspective: Prospective |
Conditions |
Breast Cancer Other Disorders of Bone Density and Structure |
Interventions |
Drug: Aromatase Inhibitors Drug: Chemotherapy |
Enrollment | 290 |
Participant Flow
Recruitment Details | A total of 290 post-menopausal female patients with ER-positive early breast cancer (BC) entered the study between February 2011 and December 2012. All 12 participating centers are hospitals where members of the Hellenic Society of Breast Surgeons operate. |
Pre-assignment Details |
Arm/Group Title | CT Cohort | HT Cohort |
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Patients were treated with a third generation AI, as subsequent endocrine therapy after initial treatment with chemotherapy (CT cohort), and were followed up for a 12-month period. | Patients were treated with a third generation AI, as adjuvant therapy (HT cohort) and were followed up for a 12-month period. |
Period Title: Overall Study | ||
Started | 124 | 166 |
Completed | 86 | 123 |
Not Completed | 38 | 43 |
Reason Not Completed | ||
Did not provide 12month BMD measurements | 38 | 43 |
Baseline Characteristics
Arm/Group Title | CT Cohort | HT Cohort | Total | |
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Patients were treated with a third generation AI, as subsequent endocrine therapy after initial treatment with chemotherapy (CT cohort), and were followed up for a 12-month period. | Patients were treated with a third generation AI, as adjuvant therapy (HT cohort) and were followed up for a 12-month period. | Total of all reporting groups | |
Overall Number of Baseline Participants | 86 | 123 | 209 | |
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This analysis is based on the 209 patients having full data (i.e. BMD measurements at baseline and at 12 months) however, their profile is similar to the profile of the whole sample of 290 patients originally enrolled.
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Age, Categorical
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 86 participants | 123 participants | 209 participants | |
<=18 years |
0 0.0%
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0 0.0%
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0 0.0%
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Between 18 and 65 years |
61 70.9%
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63 51.2%
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124 59.3%
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>=65 years |
25 29.1%
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60 48.8%
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85 40.7%
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Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
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Number Analyzed | 86 participants | 123 participants | 209 participants | |
61.3 (8.9) | 65.8 (9.2) | 63.9 (9.1) | ||
Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 86 participants | 123 participants | 209 participants | |
Female |
86 100.0%
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123 100.0%
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209 100.0%
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Male |
0 0.0%
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0 0.0%
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0 0.0%
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BMI
Mean (Standard Deviation) Unit of measure: Kg/m^2 |
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Number Analyzed | 86 participants | 123 participants | 209 participants | |
29.6 (5.4) | 29.3 (5.3) | 29.4 (5.3) | ||
Smoker
Measure Type: Number Unit of measure: Participants |
Number Analyzed | 86 participants | 123 participants | 209 participants |
Current smoker | 20 | 21 | 41 | |
Ex smoker | 14 | 9 | 23 | |
Non smoker | 52 | 93 | 145 | |
Physical Exercise
Measure Type: Number Unit of measure: Participants |
Number Analyzed | 86 participants | 123 participants | 209 participants |
Yes | 12 | 22 | 34 | |
No | 74 | 101 | 175 | |
Osteopenia/osteoporosis before AI start
Measure Type: Number Unit of measure: Participants |
Number Analyzed | 86 participants | 123 participants | 209 participants |
Present | 16 | 34 | 50 | |
Absent | 70 | 89 | 159 | |
1st degree relative with osteoporosis
Measure Type: Number Unit of measure: Participants |
Number Analyzed | 86 participants | 123 participants | 209 participants |
Yes | 7 | 15 | 22 | |
No | 79 | 108 | 187 | |
Number of fractures in the past
Mean (Standard Deviation) Unit of measure: Fractures |
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Number Analyzed | 86 participants | 123 participants | 209 participants | |
1.2 (0.4) | 1.2 (0.4) | 1.2 (0.4) | ||
Fracture History
Measure Type: Number Unit of measure: Participants |
Number Analyzed | 86 participants | 123 participants | 209 participants |
Yes | 10 | 13 | 23 | |
No | 76 | 110 | 186 | |
Orthopedic Surgery
Measure Type: Number Unit of measure: Participants |
Number Analyzed | 86 participants | 123 participants | 209 participants |
Yes | 5 | 9 | 14 | |
No | 81 | 114 | 195 |
Outcome Measures
Adverse Events
Limitations and Caveats
[Not Specified]
More Information
Results Point of Contact
Name/Title: | Christos J Markopoulos, MD, MPhil Professor of Surgery-Athens University Medical School |
Organization: | Hellenic Society of Breast Surgeons |
Phone: | +30 210 6862527 |
EMail: | cmarkop@hol.gr |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Hellenic Breast Surgeons Society |
ClinicalTrials.gov Identifier: | NCT01298362 |
Other Study ID Numbers: |
POCHARBI - 2010/02 |
First Submitted: | February 16, 2011 |
First Posted: | February 17, 2011 |
Results First Submitted: | June 20, 2016 |
Results First Posted: | September 20, 2016 |
Last Update Posted: | September 20, 2016 |