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

Breast Cancer Clinical Trial

— POCHARBI  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01298362
• Other study ID #: POCHARBI - 2010/02
• Status: Completed
• Phase: N/A
• First received: February 16, 2011
• Last updated: July 19, 2014
• Start date: March 2011
• Est. completion date: March 2014

Study information

• Verified date: July 2014
• Source: Hellenic Breast Surgeons Society
• Contact: n/a
• Is FDA regulated: No
• Health authority: Greece: National Organization of Medicines
• Study type: Observational

Clinical Trial 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 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 290
• Est. completion date: March 2014
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 40 Years to 90 Years

Eligibility

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.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Bone Diseases
• Breast Cancer
• Breast Neoplasms
• Other Disorders of Bone Density and Structure

Locations

Country	Name	City	State
Greece	Hellenic Breast Surgeons Society	Athens	Attica

Sponsors (1)

Lead Sponsor	Collaborator
Hellenic Breast Surgeons Society

Country where clinical trial is conducted

Greece, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean percentage change in lumbar spine bone mineral density from baseline (before chemotherapy commencement) to month 12 of AI therapy		13-18 months months	Yes
Secondary	Percentage change in total hip bone mineral density from baseline to month 12 of AI therapy.		13-18 months	Yes
Secondary	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		12 months	Yes
Secondary	Bone fracture rate		12 months	Yes
Secondary	Medication profile		13-18 months	No
Secondary	Mean percentage change in lumbar spine bone mineral density from baseline (before chemotherapy commencement) to chemotherapy completion		1-6 months	Yes
Secondary	Mean percentage change in lumbar spine bone mineral density from AI commencement to month 12 of therapy.		12 months	Yes