Clinical trial NCT01298362: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer
Other Disorders of Bone Density and Structure
Lead sponsor: Hellenic Breast Surgeons Society
Sponsor class: OTHER
First posted: 2011-02-17
Enrollment: 290
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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.

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.

Primary outcomes:
measure: Mean Percentage Change in Lumbar Spine Bone Mineral Density From Baseline (Before Chemotherapy Commencement) to Month 12 of AI Therapy
timeFrame: Baseline and month 13-18 (1-6 months of chemotherapy + 12 months of AI therapy)
Secondary outcomes:
measure: Percentage Change in Total Hip Bone Mineral Density From Baseline to Month 12 of AI Therapy.
timeFrame: Baseline and month 13-18 (1-6 months of chemotherapy + 12 months of AI therapy)
measure: 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
timeFrame: From AI commencement to month 12 of AI therapy
measure: 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
timeFrame: From AI commencement to month 12 of AI therapy
measure: Bone Fracture Rate
timeFrame: During the 12 months of AI Therapy
measure: Mean Percentage Change in Lumbar Spine Bone Mineral Density From Baseline (Before Chemotherapy Commencement) to Chemotherapy Completion
timeFrame: Baseline and month 1-6 (depending on duration of chemotherapy)
measure: Mean Percentage Change in Lumbar Spine Bone Mineral Density From AI Commencement to Month 12 of Therapy.
timeFrame: Month 1-6 (depending on duration of chemotherapy) and month 13-18
Other outcomes:
Locations:
city: Athens
country: Greece
facility: Hellenic Breast Surgeons Society
state: Attica
Study officials:
affiliation: Associate Professor of Surgery-Athens University Medical School, Director of the Breast Unit-Athens Medical Centre Private Hospital
name: Christos J Markopoulos, MD, MPhil
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.