- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01298362
Impact of Chemotherapy Followed by Aromatase Inhibitors on Bone Health of Women With ER-positive Early Breast Cancer (POCHARBI)
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
Study Overview
Status
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Attica
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Athens, Attica, Greece, 11523
- Hellenic Breast Surgeons Society
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
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.
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|
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).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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. |
Baseline and month 13-18 (1-6 months of chemotherapy + 12 months of AI therapy)
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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)
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Baseline and month 13-18 (1-6 months of chemotherapy + 12 months of AI therapy)
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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
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From AI commencement to month 12 of AI therapy
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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
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From AI commencement to month 12 of AI therapy
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Bone Fracture Rate
Time Frame: During the 12 months of AI Therapy
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During the 12 months of AI Therapy
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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)
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Baseline and month 1-6 (depending on duration of chemotherapy)
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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
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Month 1-6 (depending on duration of chemotherapy) and month 13-18
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Collaborators and Investigators
Sponsor
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
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Skin Diseases
- Neoplasms
- Neoplasms by Site
- Breast Diseases
- Musculoskeletal Diseases
- Breast Neoplasms
- Bone Diseases
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Hormone Antagonists
- Steroid Synthesis Inhibitors
- Estrogen Antagonists
- Aromatase Inhibitors
Other Study ID Numbers
- POCHARBI - 2010/02
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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