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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

Tracking Information
First Submitted Date February 16, 2011
First Posted Date February 17, 2011
Results First Submitted Date June 20, 2016
Results First Posted Date September 20, 2016
Last Update Posted Date September 20, 2016
Study Start Date March 2011
Actual Primary Completion Date December 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: July 31, 2016)
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) ]
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.
Original Primary Outcome Measures
 (submitted: February 16, 2011)
Mean Percentage Change in Lumbar Spine Bone Mineral Density From Baseline (Before Chemotherapy Commencement) to Month 12 of AI Therapy [ Time Frame: 13-18 months months ]
Change History
Current Secondary Outcome Measures
 (submitted: July 31, 2016)
  • 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) ]
  • 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 ]
  • 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 ]
  • Bone Fracture Rate [ Time Frame: During the 12 months of AI Therapy ]
  • 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) ]
  • 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 ]
Original Secondary Outcome Measures
 (submitted: February 16, 2011)
  • Percentage Change in Total Hip Bone Mineral Density From Baseline to Month 12 of AI Therapy. [ Time Frame: 13-18 months ]
  • Percentage change in lumbar spine and 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: 12 months ]
  • Bone Fracture Rate [ Time Frame: 12 months ]
  • Medication profile [ Time Frame: 13-18 months ]
  • Mean Percentage Change in Lumbar Spine Bone Mineral Density From Baseline (Before Chemotherapy Commencement) to Chemotherapy Completion [ Time Frame: 1-6 months ]
  • Mean Percentage Change in Lumbar Spine Bone Mineral Density From AI Commencement to Month 12 of Therapy. [ Time Frame: 12 months ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Impact of Chemotherapy Followed by Aromatase Inhibitors on Bone Health of Women With ER-positive Early Breast Cancer
Official Title 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
Brief 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.
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.
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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
Condition
  • Breast Cancer
  • Other Disorders of Bone Density and Structure
Intervention
  • Drug: Aromatase Inhibitors
  • Drug: Chemotherapy
Study Groups/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.
    Intervention: 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).
    Interventions:
    • Drug: Aromatase Inhibitors
    • Drug: Chemotherapy
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: July 19, 2014)
290
Original Estimated Enrollment
 (submitted: February 16, 2011)
250
Actual Study Completion Date March 2014
Actual Primary Completion Date December 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria

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:

  • 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.
Sex/Gender
Sexes Eligible for Study: Female
Ages 40 Years to 90 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Greece
Removed Location Countries  
 
Administrative Information
NCT Number NCT01298362
Other Study ID Numbers POCHARBI - 2010/02
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Hellenic Breast Surgeons Society
Study Sponsor Hellenic Breast Surgeons Society
Collaborators Not Provided
Investigators
Principal Investigator: Christos J Markopoulos, MD, MPhil Associate Professor of Surgery-Athens University Medical School, Director of the Breast Unit-Athens Medical Centre Private Hospital
PRS Account Hellenic Breast Surgeons Society
Verification Date July 2016