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CompletedNCT01298362POCHARBIUpdated Sep 20, 2016Results posted

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

An observational study in Breast Cancer and Other Disorders of Bone Density and Structure, sponsored by Hellenic Breast Surgeons Society. Completed at 1 site in Greece. Open to female participants aged 40 Years to 90 Years. Per ClinicalTrials.gov, last updated 2016-09-20.

Sponsored by Hellenic Breast Surgeons Society · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
290
Ages
40 Years to 90 Years
Sex
Female
01

Study summary

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.

Read the detailed description

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.

02

Conditions studied

  • Breast Cancer
  • Other Disorders of Bone Density and Structure
03

In context

Breast Neoplasms

12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.

This study's enrollment of 290 is above the median of 184 across 2,642 observational studies indexed under Breast Neoplasms.

Browse Breast Neoplasms studies →

Lead sponsor

Hellenic Breast Surgeons Society is the lead sponsor of 4 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
40 Years to 90 Years
Sexes eligible
Female
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

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

Inclusion criteria

  • Provision of informed consent.
  • Age ≥ 40 years.
  • 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 present study.
  • Women who have been rendered postmenopausal prior to chemotherapy commencement and at least 12 months from last menstrual period. For subjects who are amenorrheic for \< 12 months (including patients who underwent hysterectomy, or received estrogen replacement therapy (ERT)/ hormone replacement therapy (HRT), they must have serum follicle stimulating hormone (FSH) ≥50 IU/L before the commencement of AI therapy.
  • Patients with available data on lumbar spine and total hip bone mineral density (BMD) prior to chemotherapy initiation as well as before the commencement of AI therapy.

Exclusion criteria

Exclusion Criteria:

  • Prior administration of other endocrine therapy including tamoxifen.
  • Chemotherapy-induced menopause.
  • Evidence of diseases known to interfere with bone metabolism, such as hyperparathyroidism, hyperthyroidism, osteomalacia, chronic liver disease, renal failure, hypercortisolism, malabsorption, and immobilization.
  • Evidence of bone metastasis or evidence of abnormal clinical laboratory parameters that are assessed as clinically significant by the investigator.
  • Involvement in the planning and conduct of the study.
  • Participation in other clinical study within a period of 3 months prior to any study related procedures.
  • Patients with normal bone density or mild osteopenia (T score >= -2 in any site) under treatment with oral or intravenous bisphosphonates. Vitamin D and calcium supplements are allowed.
  • Patients with severe osteopenia or osteoporosis (T score \<= -2 in any site) under treatment with intravenous bisphosphonates. Oral bisphosphonates, Vitamin D and calcium supplements are allowed.
  • Patients under treatment with oral or intravenous bisphosphonates before chemotherapy commencement.
  • Patients that stopped hormone-replacement therapy (HRT) less than 3 months before chemotherapy commencement.
  • Patients that received neo-adjuvant treatment.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
290 participants (actual)

Groups and cohorts

  • 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.

    Drug: Aromatase Inhibitors

  • 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).

    Drug: Aromatase Inhibitors · Drug: Chemotherapy

Interventions

  • DrugAromatase Inhibitors
  • DrugChemotherapy
06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Baseline and month 13-18 (1-6 months of chemotherapy + 12 months of AI therapy)

Secondary outcomes

  1. 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)

  2. 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

  3. 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

  4. Bone Fracture Rate

    Time frame: During the 12 months of AI Therapy

  5. 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)

  6. 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

07

Results

Posted Sep 20, 2016

Participant flow

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.

Participant flow — Overall Study
MilestoneCT CohortHT Cohort
Started124166
Completed86123
Not completed3843
Withdrew: Did not provide 12month bmd measurements3843

Outcome measures

PrimaryMean 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.

Time frame:
Baseline and month 13-18 (1-6 months of chemotherapy + 12 months of AI therapy)
Reported as:
Mean · percentage of change
Mean Percentage Change in Lumbar Spine Bone Mineral Density From Baseline (Before Chemotherapy Commencement) to Month 12 of AI Therapy
percentage of changeCT CohortHT Cohort
Mean Percentage Change in Lumbar Spine Bone Mineral Density From Baseline (Before Chemotherapy Commencement) to Month 12 of AI Therapy-0.72 (-2.97 to 1.53)—
SecondaryPercentage 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)
Reported as:
Mean · percentage of change
Percentage Change in Total Hip Bone Mineral Density From Baseline to Month 12 of AI Therapy.
percentage of changeCT CohortHT Cohort
Percentage Change in Total Hip Bone Mineral Density From Baseline to Month 12 of AI Therapy.0.83 (-2.56 to 4.23)—
SecondaryPercentage 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
Reported as:
Mean · percentage of change
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
percentage of changeCT CohortHT Cohort
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—1.51 (-0.96 to 3.18)
SecondaryPercentage 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
Reported as:
Mean · percentage of change
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
percentage of changeCT CohortHT Cohort
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—-0.94 (-2.58 to 0.70)
SecondaryBone Fracture Rate
Time frame:
During the 12 months of AI Therapy
Reported as:
Number · participants
Bone Fracture Rate
participantsCT CohortHT Cohort
Bone Fracture Rate00
SecondaryMean 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)
Reported as:
Mean · percentage of change
Mean Percentage Change in Lumbar Spine Bone Mineral Density From Baseline (Before Chemotherapy Commencement) to Chemotherapy Completion
percentage of changeCT CohortHT Cohort
Mean Percentage Change in Lumbar Spine Bone Mineral Density From Baseline (Before Chemotherapy Commencement) to Chemotherapy Completion-0.19 (-2.12 to 1.74)—
SecondaryMean 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
Reported as:
Mean · percentage of change
Mean Percentage Change in Lumbar Spine Bone Mineral Density From AI Commencement to Month 12 of Therapy.
percentage of changeCT CohortHT Cohort
Mean Percentage Change in Lumbar Spine Bone Mineral Density From AI Commencement to Month 12 of Therapy.-0.59 (-3.18 to 2.00)—

Adverse events

Collected over 18 months. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
CT Cohort—0/86 (0%)0/86 (0%)
HT Cohort—0/123 (0%)0/123 (0%)

Baseline characteristics

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
Age, Categorical(Participants)CT CohortHT CohortTotal
<=18 years000
Between 18 and 65 years6163124
>=65 years256085
Age, Continuous
Age, Continuous(years)CT CohortHT CohortTotal
Mean61.3 ± 8.965.8 ± 9.263.9 ± 9.1
Sex: Female, Male
Sex: Female, Male(Participants)CT CohortHT CohortTotal
Female86123209
Male000
BMI
BMI(kg/m^2)CT CohortHT CohortTotal
Mean29.6 ± 5.429.3 ± 5.329.4 ± 5.3
Smoker
Smoker(participants)CT CohortHT CohortTotal
Current smoker202141
Ex smoker14923
Non smoker5293145
Physical Exercise
Physical Exercise(participants)CT CohortHT CohortTotal
Yes122234
No74101175
Osteopenia/osteoporosis before AI start
Osteopenia/osteoporosis before AI start(participants)CT CohortHT CohortTotal
Present163450
Absent7089159
1st degree relative with osteoporosis
1st degree relative with osteoporosis(participants)CT CohortHT CohortTotal
Yes71522
No79108187

3 further baseline measures are reported on the registry.

08

Study locations

1 site
  • Hellenic Breast Surgeons Society
    Athens, Attica 11523, Greece
09

References and documents

Publications

  • 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. PubMed 27212697 ↗
10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 20, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT01298362
Lead sponsor
Hellenic Breast Surgeons Society
Responsible party
Sponsor
First posted
Feb 17, 2011
Start date
Mar 2011
Primary completion
Dec 2013
Completion
Mar 2014
Results posted
Sep 20, 2016
Last update
Sep 20, 2016

Study contacts

Christos J Markopoulos, MD, MPhil
principal investigator · Associate Professor of Surgery-Athens University Medical School, Director of the Breast Unit-Athens Medical Centre Private Hospital

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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