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The purpose of this study is to identify the combined impact on bone loss as well as the incidence of bone fractures in women with estrogen receptor (ER)-positive, early breast cancer treated with an aromatase inhibitor (AI) either as first line therapy or as maintenance therapy after initial treatment with chemotherapy, in real life clinical settings in Greece.
Subjects with ER-positive early breast cancer will be treated with AIs either as first line therapy or as maintenance therapy after initial treatment with chemotherapy. The total study duration will be 24 months comprising of a recruitment period of 12 months and a follow-up period of 12 months for each participating subject. The primary outcome variable is the mean percentage variation in lumbar spine (LS) bone mineral density (BMD) during the 12 month follow - up period. Measurements will be taken before and after chemotherapy and at the end of the 12 month follow - up period.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AIs as first line therapy | Patients in postmenopausal status, with ER-positive early breast cancer, treated with an AI as first line therapy for 12 months. |
| |
| AIs after chemotherapy | Patients in postmenopausal status, with ER-positive early breast cancer, treated with an AI as maintenance therapy for 12 months after initial treatment with anthracycline- and/or taxane-based chemotherapy (chemotherapy treatment duration: 1-6 months). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Aromatase Inhibitors | Drug |
| ||
| Chemotherapy |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Percentage Change in Lumbar Spine Bone Mineral Density From Baseline (Before Chemotherapy Commencement) to Month 12 of AI Therapy | 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. | Baseline and month 13-18 (1-6 months of chemotherapy + 12 months of AI therapy) |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage Change in Total Hip Bone Mineral Density From Baseline to Month 12 of AI Therapy. | Baseline and month 13-18 (1-6 months of chemotherapy + 12 months of AI therapy) | |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Post-menopausal female patients with ER-positive early breast cancer, who receive therapy with a third generation AI either as first line hormonal treatment or as maintenance therapy after first-line anthracycline- and/or taxane-based chemotherapy for a period no longer than 1 month (4 weeks) prior to inclusion in the study
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| Name | Affiliation | Role |
|---|---|---|
| Christos J Markopoulos, MD, MPhil | Associate Professor of Surgery-Athens University Medical School, Director of the Breast Unit-Athens Medical Centre Private Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hellenic Breast Surgeons Society | Athens | Attica | 11523 | Greece |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27212697 | Derived | Markopoulos C, Koukouras D, Venizelos V, Karyda I, Xepapadakis G, Misitzis J, Kalogerakos K, Poulakaki F, Natsiopoulos J, Zobolas V, Savidou C, Antonopoulou Z, Tzoracoleftherakis E. Impact of chemotherapy followed by aromatase inhibitors on bone health of women with ER-positive early breast cancer in real world clinical settings in Greece: Results of the POCHARBI trial conducted by the Hellenic Society of Breast Surgeons. Breast. 2016 Jun;27:27-34. doi: 10.1016/j.breast.2016.02.007. Epub 2016 Mar 20. |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | HT Cohort |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Drug |
|
| From AI commencement to month 12 of AI therapy |
| 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 | From AI commencement to month 12 of AI therapy |
| Bone Fracture Rate | During the 12 months of AI Therapy |
| Mean Percentage Change in Lumbar Spine Bone Mineral Density From Baseline (Before Chemotherapy Commencement) to Chemotherapy Completion | Baseline and month 1-6 (depending on duration of chemotherapy) |
| Mean Percentage Change in Lumbar Spine Bone Mineral Density From AI Commencement to Month 12 of Therapy. | Month 1-6 (depending on duration of chemotherapy) and month 13-18 |
Patients were treated with a third generation AI, as adjuvant therapy (HT cohort) and were followed up for a 12-month period.
| COMPLETED |
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| NOT COMPLETED |
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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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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | HT Cohort | Patients were treated with a third generation AI, as adjuvant therapy (HT cohort) and were followed up for a 12-month period. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| BMI | Mean | Standard Deviation | kg/m^2 |
| |||||||||||||||||
| Smoker | Number | participants |
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| Physical Exercise | Number | participants |
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| Osteopenia/osteoporosis before AI start | Number | participants |
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| 1st degree relative with osteoporosis | Number | participants |
| ||||||||||||||||||
| Number of fractures in the past | Mean | Standard Deviation | fractures |
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| Fracture History | Number | participants |
| ||||||||||||||||||
| Orthopedic Surgery | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Mean Percentage Change in Lumbar Spine Bone Mineral Density From Baseline (Before Chemotherapy Commencement) to Month 12 of AI Therapy | 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. | Patients with LS BMd measurements both at baseline and at 12 months of AI therapy. | Posted | Mean | 95% Confidence Interval | percentage of change | Baseline and month 13-18 (1-6 months of chemotherapy + 12 months of AI therapy) |
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| ||||||||||||||||||||||||||||
| Secondary | Percentage Change in Total Hip Bone Mineral Density From Baseline to Month 12 of AI Therapy. | Patients with HIP BMD measurements both at baseline and at 12 months of AI therapy. | Posted | Mean | 95% Confidence Interval | percentage of change | Baseline and month 13-18 (1-6 months of chemotherapy + 12 months of AI therapy) |
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| 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 | Patients with LS BMD measurements both at AI commencement and at 12 months of AI therapy. | Posted | Mean | 95% Confidence Interval | percentage of change | From AI commencement to month 12 of AI therapy |
|
| ||||||||||||||||||||||||||||||
| 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 | Patients with HIP BMD measurements both at AI commencement and at 12 months of AI therapy. | Posted | Mean | 95% Confidence Interval | percentage of change | From AI commencement to month 12 of AI therapy |
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| ||||||||||||||||||||||||||||||
| Secondary | Bone Fracture Rate | All patients with available 12 month follow-up during AI treatment | Posted | Number | participants | During the 12 months of AI Therapy |
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| Secondary | Mean Percentage Change in Lumbar Spine Bone Mineral Density From Baseline (Before Chemotherapy Commencement) to Chemotherapy Completion | Patients with LS BMD measurements both at baseline (before chemotherapy commencement) and at chemotherapy completion | Posted | Mean | 95% Confidence Interval | percentage of change | Baseline and month 1-6 (depending on duration of chemotherapy) |
|
| ||||||||||||||||||||||||||||||
| Secondary | Mean Percentage Change in Lumbar Spine Bone Mineral Density From AI Commencement to Month 12 of Therapy. | Patients with LS BMD measurements both at AI commencement and at 12 months of AI therapy. | Posted | Mean | 95% Confidence Interval | percentage of change | Month 1-6 (depending on duration of chemotherapy) and month 13-18 |
|
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18 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. | 0 | 86 | 0 | 86 | ||
| EG001 | HT Cohort | Patients were treated with a third generation AI, as adjuvant therapy (HT cohort) and were followed up for a 12-month period. | 0 | 123 | 0 | 123 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Christos J Markopoulos, MD, MPhil Professor of Surgery-Athens University Medical School | Hellenic Society of Breast Surgeons | +30 210 6862527 | cmarkop@hol.gr |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D047072 | Aromatase Inhibitors |
| D004358 | Drug Therapy |
| ID | Term |
|---|---|
| D065088 | Steroid Synthesis Inhibitors |
| D004791 | Enzyme Inhibitors |
| D045504 | Molecular Mechanisms of Pharmacological Action |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D004965 | Estrogen Antagonists |
| D006727 | Hormone Antagonists |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D045505 | Physiological Effects of Drugs |
| D013812 | Therapeutics |
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| >=65 years |
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| Male |
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| Ex smoker |
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| Non smoker |
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| No |
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| Absent |
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| No |
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| No |
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| No |
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