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Impact of Chemotherapy Followed by Aromatase Inhibitors on Bone Health of Women With ER-positive Early Breast Cancer (POCHARBI)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01298362
First Posted: February 17, 2011
Last Update Posted: September 20, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Hellenic Breast Surgeons Society
Results First Submitted: June 20, 2016  
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

  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
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
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
CT Cohort 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.
HT Cohort Patients were treated with a third generation AI, as adjuvant therapy (HT cohort) and were followed up for a 12-month period.

Participant Flow:   Overall Study
    CT Cohort   HT Cohort
STARTED   124   166 
COMPLETED   86   123 
NOT COMPLETED   38   43 
Did not provide 12month BMD measurements                38                43 



  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.
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.

Reporting Groups
  Description
CT Cohort 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.
HT Cohort Patients were treated with a third generation AI, as adjuvant therapy (HT cohort) and were followed up for a 12-month period.
Total Total of all reporting groups

Baseline Measures
   CT Cohort   HT Cohort   Total 
Overall Participants Analyzed 
[Units: Participants]
 86   123   209 
Age 
[Units: Participants]
     
<=18 years   0   0   0 
Between 18 and 65 years   61   63   124 
>=65 years   25   60   85 
Age 
[Units: Years]
Mean (Standard Deviation)
 61.3  (8.9)   65.8  (9.2)   63.9  (9.1) 
Gender 
[Units: Participants]
     
Female   86   123   209 
Male   0   0   0 
BMI 
[Units: Kg/m^2]
Mean (Standard Deviation)
 29.6  (5.4)   29.3  (5.3)   29.4  (5.3) 
Smoker 
[Units: Participants]
     
Current smoker   20   21   41 
Ex smoker   14   9   23 
Non smoker   52   93   145 
Physical Exercise 
[Units: Participants]
     
Yes   12   22   34 
No   74   101   175 
Osteopenia/osteoporosis before AI start 
[Units: Participants]
     
Present   16   34   50 
Absent   70   89   159 
1st degree relative with osteoporosis 
[Units: Participants]
     
Yes   7   15   22 
No   79   108   187 
Number of fractures in the past 
[Units: Fractures]
Mean (Standard Deviation)
 1.2  (0.4)   1.2  (0.4)   1.2  (0.4) 
Fracture History 
[Units: Participants]
     
Yes   10   13   23 
No   76   110   186 
Orthopedic Surgery 
[Units: Participants]
     
Yes   5   9   14 
No   81   114   195 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Mean Percentage Change in Lumbar Spine Bone Mineral Density From Baseline (Before Chemotherapy Commencement) to Month 12 of AI Therapy   [ Time Frame: Baseline and month 13-18 (1-6 months of chemotherapy + 12 months of AI therapy) ]

2.  Secondary:   Percentage Change in Total Hip Bone Mineral Density From Baseline to Month 12 of AI Therapy.   [ Time Frame: Baseline and month 13-18 (1-6 months of chemotherapy + 12 months of AI therapy) ]

3.  Secondary:   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   [ Time Frame: From AI commencement to month 12 of AI therapy ]

4.  Secondary:   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   [ Time Frame: From AI commencement to month 12 of AI therapy ]

5.  Secondary:   Bone Fracture Rate   [ Time Frame: During the 12 months of AI Therapy ]

6.  Secondary:   Mean Percentage Change in Lumbar Spine Bone Mineral Density From Baseline (Before Chemotherapy Commencement) to Chemotherapy Completion   [ Time Frame: Baseline and month 1-6 (depending on duration of chemotherapy) ]

7.  Secondary:   Mean Percentage Change in Lumbar Spine Bone Mineral Density From AI Commencement to Month 12 of Therapy.   [ Time Frame: Month 1-6 (depending on duration of chemotherapy) and month 13-18 ]


  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
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  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: Christos J Markopoulos, MD, MPhil Professor of Surgery-Athens University Medical School
Organization: Hellenic Society of Breast Surgeons
phone: +30 210 6862527
e-mail: 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     History of Changes
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