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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
Sponsor:
Information provided by (Responsible Party):
Hellenic Breast Surgeons Society

Study Type Observational
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
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
Hide Arm/Group Description 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
Arm/Group Title CT Cohort HT Cohort Total
Hide Arm/Group Description 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
Hide Baseline Analysis Population Description
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.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 86 participants 123 participants 209 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
61
  70.9%
63
  51.2%
124
  59.3%
>=65 years
25
  29.1%
60
  48.8%
85
  40.7%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
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
Number Analyzed 86 participants 123 participants 209 participants
Female
86
 100.0%
123
 100.0%
209
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
BMI  
Mean (Standard Deviation)
Unit of measure:  Kg/m^2
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
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
1.Primary Outcome
Title Mean Percentage Change in Lumbar Spine Bone Mineral Density From Baseline (Before Chemotherapy Commencement) to Month 12 of AI Therapy
Hide Description

BMD was evaluated at lumbar spine (LS) and hip (HIP) with measurements taken before CT, before AI therapy and at the end of the 12 month followup period while on AI treatment. Dual Energy X-Ray Absorptiometry (DEXA scan) was used with all measurements performed with the Explorer absorptiometer produced by Hologic, Bedford, MA, USA in the same referral site in Athens, apart from two centres in other cities which used however the same absorptiometer model with identical software.

The primary outcome variable was the mean percentage change in LS BMD between the pre CT treatment measurement and the post 12 months AI measurements in the CT cohort. The HT cohort was included as a control group.

Time Frame Baseline and month 13-18 (1-6 months of chemotherapy + 12 months of AI therapy)
Hide Outcome Measure Data
Hide Analysis Population Description
Patients with LS BMd measurements both at baseline and at 12 months of AI therapy.
Arm/Group Title CT Cohort HT Cohort
Hide Arm/Group Description:
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.

In the HT cohort patients were treated with a third generation AI, as adjuvant therapy (HT cohort) and were followed up for a 12-month period.

The primary outcome variable was the mean percentage change in LS BMD between the pre CT treatment measurement and the post 12 months AI measurements in the CT cohort. The HT cohort was included as a control group.

BMD measurements in HT cohort were taken before AI start and at 12 months.

Overall Number of Participants Analyzed 86 0
Mean (95% Confidence Interval)
Unit of Measure: percentage of change
-0.72
(-2.97 to 1.53)
2.Secondary Outcome
Title Percentage Change in Total Hip Bone Mineral Density From Baseline to Month 12 of AI Therapy.
Hide Description [Not Specified]
Time Frame Baseline and month 13-18 (1-6 months of chemotherapy + 12 months of AI therapy)
Hide Outcome Measure Data
Hide Analysis Population Description
Patients with HIP BMD measurements both at baseline and at 12 months of AI therapy.
Arm/Group Title CT Cohort HT Cohort
Hide Arm/Group Description:
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.
In the HT cohort patients were treated with a third generation AI, as adjuvant therapy (HT cohort) and were followed up for a 12-month period.
Overall Number of Participants Analyzed 86 0
Mean (95% Confidence Interval)
Unit of Measure: percentage of change
0.83
(-2.56 to 4.23)
3.Secondary Outcome
Title Percentage Change in Lumbar Spine Bone Mineral Density Before AI Commencement to Month 12 of Therapy for Patients Who Are Treated With AIs as First Line Therapy
Hide Description [Not Specified]
Time Frame From AI commencement to month 12 of AI therapy
Hide Outcome Measure Data
Hide Analysis Population Description
Patients with LS BMD measurements both at AI commencement and at 12 months of AI therapy.
Arm/Group Title CT Cohort HT Cohort
Hide Arm/Group Description:
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.
In the HT cohort patients were treated with a third generation AI, as adjuvant therapy (HT cohort) and were followed up for a 12-month period.
Overall Number of Participants Analyzed 0 123
Mean (95% Confidence Interval)
Unit of Measure: percentage of change
1.51
(-0.96 to 3.18)
4.Secondary Outcome
Title Percentage Change in Total Hip Bone Mineral Density Before AI Commencement to Month 12 of Therapy for Patients Who Are Treated With AIs as First Line Therapy
Hide Description [Not Specified]
Time Frame From AI commencement to month 12 of AI therapy
Hide Outcome Measure Data
Hide Analysis Population Description
Patients with HIP BMD measurements both at AI commencement and at 12 months of AI therapy.
Arm/Group Title CT Cohort HT Cohort
Hide Arm/Group Description:
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.
In the HT cohort patients were treated with a third generation AI, as adjuvant therapy (HT cohort) and were followed up for a 12-month period.
Overall Number of Participants Analyzed 0 123
Mean (95% Confidence Interval)
Unit of Measure: percentage of change
-0.94
(-2.58 to 0.70)
5.Secondary Outcome
Title Bone Fracture Rate
Hide Description [Not Specified]
Time Frame During the 12 months of AI Therapy
Hide Outcome Measure Data
Hide Analysis Population Description
All patients with available 12 month follow-up during AI treatment
Arm/Group Title CT Cohort HT Cohort
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 86 123
Measure Type: Number
Unit of Measure: participants
0 0
6.Secondary Outcome
Title Mean Percentage Change in Lumbar Spine Bone Mineral Density From Baseline (Before Chemotherapy Commencement) to Chemotherapy Completion
Hide Description [Not Specified]
Time Frame Baseline and month 1-6 (depending on duration of chemotherapy)
Hide Outcome Measure Data
Hide Analysis Population Description
Patients with LS BMD measurements both at baseline (before chemotherapy commencement) and at chemotherapy completion
Arm/Group Title CT Cohort HT Cohort
Hide Arm/Group Description:
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.
In the HT cohort patients were treated with a third generation AI, as adjuvant therapy (HT cohort) and were followed up for a 12-month period.
Overall Number of Participants Analyzed 86 0
Mean (95% Confidence Interval)
Unit of Measure: percentage of change
-0.19
(-2.12 to 1.74)
7.Secondary Outcome
Title Mean Percentage Change in Lumbar Spine Bone Mineral Density From AI Commencement to Month 12 of Therapy.
Hide Description [Not Specified]
Time Frame Month 1-6 (depending on duration of chemotherapy) and month 13-18
Hide Outcome Measure Data
Hide Analysis Population Description
Patients with LS BMD measurements both at AI commencement and at 12 months of AI therapy.
Arm/Group Title CT Cohort HT Cohort
Hide Arm/Group Description:
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.
In the HT cohort patients were treated with a third generation AI, as adjuvant therapy (HT cohort) and were followed up for a 12-month period.
Overall Number of Participants Analyzed 86 0
Mean (95% Confidence Interval)
Unit of Measure: percentage of change
-0.59
(-3.18 to 2.00)
Time Frame 18 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title CT Cohort HT Cohort
Hide Arm/Group Description 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.
All-Cause Mortality
CT Cohort HT Cohort
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Hide Serious Adverse Events
CT Cohort HT Cohort
Affected / at Risk (%) Affected / at Risk (%)
Total   0/86 (0.00%)   0/123 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
CT Cohort HT Cohort
Affected / at Risk (%) Affected / at Risk (%)
Total   0/86 (0.00%)   0/123 (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
Layout table for Results Point of Contact information
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
Layout table for additonal information
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