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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


N/A
40 Years
90 Years
Open (Enrolling)
Female
Breast Cancer, Other Disorders of Bone Density and Structure

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Trial Information

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


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.


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.

Type of Study:

Observational

Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome Measure:

Mean percentage change in lumbar spine bone mineral density from baseline (before chemotherapy commencement) to month 12 of AI therapy

Outcome Time Frame:

13-18 months months

Safety Issue:

Yes

Principal Investigator

Christos J Markopoulos, MD, MPhil

Investigator Role:

Principal Investigator

Investigator Affiliation:

Associate Professor of Surgery-Athens University Medical School, Director of the Breast Unit-Athens Medical Centre Private Hospital

Authority:

Greece: National Organization of Medicines

Study ID:

POCHARBI - 2010/02

NCT ID:

NCT01298362

Start Date:

March 2011

Completion Date:

March 2014

Related Keywords:

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

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