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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hellenic Breast Surgeons Society
ClinicalTrials.gov Identifier:
NCT01298362
First received: February 16, 2011
Last updated: July 31, 2016
Last verified: July 2016
  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 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.

Condition Intervention
Breast Cancer
Other Disorders of Bone Density and Structure
Drug: Aromatase Inhibitors
Drug: Chemotherapy

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: Baseline and month 13-18 (1-6 months of chemotherapy + 12 months of AI therapy) ] [ Designated as safety issue: Yes ]

    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.



Secondary Outcome Measures:
  • 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) ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
  • Bone Fracture Rate [ Time Frame: During the 12 months of AI Therapy ] [ Designated as safety issue: Yes ]
  • 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) ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]

Enrollment: 290
Study Start Date: March 2011
Study Completion Date: March 2014
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

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.
  Eligibility

Ages Eligible for Study:   40 Years to 90 Years   (Adult, Senior)
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 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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
Results First Received: June 20, 2016
Last Updated: July 31, 2016
Health Authority: Greece: National Organization of Medicines

Additional relevant MeSH terms:
Breast Neoplasms
Bone Diseases
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Musculoskeletal Diseases
Aromatase Inhibitors
Steroid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Estrogen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on December 02, 2016