Impact of Chemotherapy Followed by Aromatase Inhibitors on Bone Health of Women With ER-positive Early Breast Cancer (POCHARBI)
This study is ongoing, but not recruiting participants.
Sponsor:
Hellenic Breast Surgeons Society
Information provided by (Responsible Party):
Hellenic Breast Surgeons Society
ClinicalTrials.gov Identifier:
NCT01298362
First received: February 16, 2011
Last updated: January 11, 2013
Last verified: January 2013
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Purpose
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 ER-positive, early breast cancer treated with an AI either as first line therapy or as maintenance therapy after initial treatment with chemotherapy, in real life clinical settings in Greece.
| Condition |
|---|
|
Breast Cancer Other Disorders of Bone Density and Structure |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| 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 |
Resource links provided by NLM:
Further study details as provided by Hellenic Breast Surgeons Society:
Primary Outcome Measures:
- 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 ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Percentage change in total hip bone mineral density from baseline to month 12 of AI therapy. [ Time Frame: 13-18 months ] [ Designated as safety issue: Yes ]
- 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 ] [ Designated as safety issue: Yes ]
- Bone fracture rate [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
- Medication profile [ Time Frame: 13-18 months ] [ Designated as safety issue: No ]
- Mean percentage change in lumbar spine bone mineral density from baseline (before chemotherapy commencement) to chemotherapy completion [ Time Frame: 1-6 months ] [ Designated as safety issue: Yes ]
- Mean percentage change in lumbar spine bone mineral density from AI commencement to month 12 of therapy. [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 250 |
| Study Start Date: | March 2011 |
| Estimated Study Completion Date: | March 2014 |
| Estimated Primary Completion Date: | December 2013 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
| AIs as first line therapy |
| AIs after chemotherapy |
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 bone mineral density 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.
Eligibility| Ages Eligible for Study: | 40 Years to 90 Years |
| Genders Eligible for Study: | 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
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 ERT/HRT), they must have serum FSH ≥50 UI/L before the commencement of AI therapy.
- Patients with available data on lumbar spine and total hip 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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01298362
Locations
| Greece | |
| Hellenic Breast Surgeons Society | |
| Athens, Attica, Greece, 11523 | |
Sponsors and Collaborators
Hellenic Breast Surgeons Society
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 |
More Information
No publications provided
| 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 |
| Last Updated: | January 11, 2013 |
| Health Authority: | Greece: National Organization of Medicines |
Additional relevant MeSH terms:
|
Bone Diseases Breast Neoplasms Musculoskeletal Diseases Neoplasms by Site Neoplasms Breast Diseases |
Skin Diseases Aromatase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 23, 2013