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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:
Information provided by (Responsible Party):
Hellenic Breast Surgeons Society
ClinicalTrials.gov Identifier:
NCT01298362
First received: February 16, 2011
Last updated: July 31, 2016
Last verified: July 2016
Results First Received: 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
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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  
Number of Participants  
[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
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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



Responsible Party: Hellenic Breast Surgeons Society
ClinicalTrials.gov Identifier: NCT01298362     History of Changes
Other Study ID Numbers: POCHARBI - 2010/02
Study First Received: February 16, 2011
Results First Received: June 20, 2016
Last Updated: July 31, 2016
Health Authority: Greece: National Organization of Medicines