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

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ClinicalTrials.gov Identifier: NCT01298362

Recruitment Status : Completed

First Posted : February 17, 2011

Results First Posted : September 20, 2016

Last Update Posted : September 20, 2016

Sponsor:

Information provided by (Responsible Party):

Hellenic Breast Surgeons Society

Study Type	Observational
Study Design	Observational Model: Cohort; Time Perspective: Prospective
Conditions	Breast Cancer Other Disorders of Bone Density and Structure
Interventions	Drug: Aromatase Inhibitors Drug: Chemotherapy
Enrollment	290

Participant Flow

Recruitment Details	A total of 290 post-menopausal female patients with ER-positive early breast cancer (BC) entered the study between February 2011 and December 2012. All 12 participating centers are hospitals where members of the Hellenic Society of Breast Surgeons operate.
Pre-assignment Details


Arm/Group Title	CT Cohort	HT Cohort
Arm/Group Description	Patients were treated with a third ...	Patients were treated with a third ...
Arm/Group Description	Patients were treated with a third generation AI, as subsequent endocrine therapy after initial treatment with chemotherapy (CT cohort), and were followed up for a 12-month period.	Patients were treated with a third generation AI, as adjuvant therapy (HT cohort) and were followed up for a 12-month period.
Period Title: Overall Study
Started	124	166
Completed	86	123
Not Completed	38	43
Reason Not Completed
Did not provide 12month BMD measurements	38	43

Baseline Characteristics

Arm/Group Title		CT Cohort	HT Cohort	Total
Arm/Group Description		Patients were treated with a third ...	Patients were treated with a third ...	Total of all reporting groups
Arm/Group Description		Patients were treated with a third generation AI, as subsequent endocrine therapy after initial treatment with chemotherapy (CT cohort), and were followed up for a 12-month period.	Patients were treated with a third generation AI, as adjuvant therapy (HT cohort) and were followed up for a 12-month period.	Total of all reporting groups
Overall Number of Baseline Participants		86	123	209
Baseline Analysis Population Description		...
Baseline Analysis Population Description		This analysis is based on the 209 patients having full data (i.e. BMD measurements at baseline and at 12 months) however, their proﬁle is similar to the proﬁle of the whole sample of 290 patients originally enrolled.
Age, Categorical Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	86 participants	123 participants	209 participants
	<=18 years	0 0.0%	0 0.0%	0 0.0%
	Between 18 and 65 years	61 70.9%	63 51.2%	124 59.3%
	>=65 years	25 29.1%	60 48.8%	85 40.7%
Age, Continuous Mean (Standard Deviation) Unit of measure: Years
	Number Analyzed	86 participants	123 participants	209 participants
		61.3 (8.9)	65.8 (9.2)	63.9 (9.1)
Sex: Female, Male Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	86 participants	123 participants	209 participants
	Female	86 100.0%	123 100.0%	209 100.0%
	Male	0 0.0%	0 0.0%	0 0.0%
BMI Mean (Standard Deviation) Unit of measure: Kg/m^2
	Number Analyzed	86 participants	123 participants	209 participants
		29.6 (5.4)	29.3 (5.3)	29.4 (5.3)
Smoker Measure Type: Number Unit of measure: Participants	Number Analyzed	86 participants	123 participants	209 participants
Current smoker		20	21	41
Ex smoker		14	9	23
Non smoker		52	93	145
Physical Exercise Measure Type: Number Unit of measure: Participants	Number Analyzed	86 participants	123 participants	209 participants
Yes		12	22	34
No		74	101	175
Osteopenia/osteoporosis before AI start Measure Type: Number Unit of measure: Participants	Number Analyzed	86 participants	123 participants	209 participants
Present		16	34	50
Absent		70	89	159
1st degree relative with osteoporosis Measure Type: Number Unit of measure: Participants	Number Analyzed	86 participants	123 participants	209 participants
Yes		7	15	22
No		79	108	187
Number of fractures in the past Mean (Standard Deviation) Unit of measure: Fractures
	Number Analyzed	86 participants	123 participants	209 participants
		1.2 (0.4)	1.2 (0.4)	1.2 (0.4)
Fracture History Measure Type: Number Unit of measure: Participants	Number Analyzed	86 participants	123 participants	209 participants
Yes		10	13	23
No		76	110	186
Orthopedic Surgery Measure Type: Number Unit of measure: Participants	Number Analyzed	86 participants	123 participants	209 participants
Yes		5	9	14
No		81	114	195

Outcome Measures

1.Primary Outcome


Title	Mean Percentage Change in Lumbar Spine Bone Mineral Density From Baseline (Before Chemotherapy Commencement) to Month 12 of AI Therapy
Description	BMD was evaluated at lum...
Description	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.
Time Frame	Baseline and month 13-18 (1-6 months of chemotherapy + 12 months of AI therapy)

Outcome Measure Data