Trial Outcomes & Findings for Impact of Chemotherapy Followed by Aromatase Inhibitors on Bone Health of Women With ER-positive Early Breast Cancer (NCT NCT01298362)

Last Updated: 2016-09-20

Results Overview

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.

Recruitment status

COMPLETED

Target enrollment

290 participants

Primary outcome timeframe

Baseline and month 13-18 (1-6 months of chemotherapy + 12 months of AI therapy)

Results posted on

2016-09-20

Participant Flow

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.

Participant milestones

Participant milestones
Measure	CT Cohort 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.	HT Cohort Patients were treated with a third generation AI, as adjuvant therapy (HT cohort) and were followed up for a 12-month period.
Overall Study STARTED	124	166
Overall Study COMPLETED	86	123
Overall Study NOT COMPLETED	38	43

Reasons for withdrawal

Reasons for withdrawal
Measure	CT Cohort 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.	HT Cohort Patients were treated with a third generation AI, as adjuvant therapy (HT cohort) and were followed up for a 12-month period.
Overall Study Did not provide 12month BMD measurements	38	43

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	CT Cohort n=86 Participants 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.	HT Cohort n=123 Participants Patients were treated with a third generation AI, as adjuvant therapy (HT cohort) and were followed up for a 12-month period.	Total n=209 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	61 Participants n=5 Participants	63 Participants n=7 Participants	124 Participants n=5 Participants
Age, Categorical >=65 years	25 Participants n=5 Participants	60 Participants n=7 Participants	85 Participants n=5 Participants
Age, Continuous	61.3 years STANDARD_DEVIATION 8.9 • n=5 Participants	65.8 years STANDARD_DEVIATION 9.2 • n=7 Participants	63.9 years STANDARD_DEVIATION 9.1 • n=5 Participants
Sex: Female, Male Female	86 Participants n=5 Participants	123 Participants n=7 Participants	209 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
BMI	29.6 kg/m^2 STANDARD_DEVIATION 5.4 • n=5 Participants	29.3 kg/m^2 STANDARD_DEVIATION 5.3 • n=7 Participants	29.4 kg/m^2 STANDARD_DEVIATION 5.3 • n=5 Participants
Smoker Current smoker	20 participants n=5 Participants	21 participants n=7 Participants	41 participants n=5 Participants
Smoker Ex smoker	14 participants n=5 Participants	9 participants n=7 Participants	23 participants n=5 Participants
Smoker Non smoker	52 participants n=5 Participants	93 participants n=7 Participants	145 participants n=5 Participants
Physical Exercise Yes	12 participants n=5 Participants	22 participants n=7 Participants	34 participants n=5 Participants
Physical Exercise No	74 participants n=5 Participants	101 participants n=7 Participants	175 participants n=5 Participants
Osteopenia/osteoporosis before AI start Present	16 participants n=5 Participants	34 participants n=7 Participants	50 participants n=5 Participants
Osteopenia/osteoporosis before AI start Absent	70 participants n=5 Participants	89 participants n=7 Participants	159 participants n=5 Participants
1st degree relative with osteoporosis Yes	7 participants n=5 Participants	15 participants n=7 Participants	22 participants n=5 Participants
1st degree relative with osteoporosis No	79 participants n=5 Participants	108 participants n=7 Participants	187 participants n=5 Participants
Number of fractures in the past	1.2 fractures STANDARD_DEVIATION 0.4 • n=5 Participants	1.2 fractures STANDARD_DEVIATION 0.4 • n=7 Participants	1.2 fractures STANDARD_DEVIATION 0.4 • n=5 Participants
Fracture History Yes	10 participants n=5 Participants	13 participants n=7 Participants	23 participants n=5 Participants
Fracture History No	76 participants n=5 Participants	110 participants n=7 Participants	186 participants n=5 Participants
Orthopedic Surgery Yes	5 participants n=5 Participants	9 participants n=7 Participants	14 participants n=5 Participants
Orthopedic Surgery No	81 participants n=5 Participants	114 participants n=7 Participants	195 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline and month 13-18 (1-6 months of chemotherapy + 12 months of AI therapy)

Population: Patients with LS BMd measurements both at baseline and at 12 months of AI therapy.

Outcome measures

Outcome measures
Measure	CT Cohort n=86 Participants 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.	HT Cohort In the HT cohort patients were treated with a third generation AI, as adjuvant therapy (HT cohort) and were followed up for a 12-month period. 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. BMD measurements in HT cohort were taken before AI start and at 12 months.
Mean Percentage Change in Lumbar Spine Bone Mineral Density From Baseline (Before Chemotherapy Commencement) to Month 12 of AI Therapy	-0.72 percentage of change Interval -2.97 to 1.53	—

SECONDARY outcome

Timeframe: Baseline and month 13-18 (1-6 months of chemotherapy + 12 months of AI therapy)

Population: Patients with HIP BMD measurements both at baseline and at 12 months of AI therapy.

Outcome measures

Outcome measures
Measure	CT Cohort n=86 Participants 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.	HT Cohort In the HT cohort patients were treated with a third generation AI, as adjuvant therapy (HT cohort) and were followed up for a 12-month period. 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. BMD measurements in HT cohort were taken before AI start and at 12 months.
Percentage Change in Total Hip Bone Mineral Density From Baseline to Month 12 of AI Therapy.	0.83 percentage of change Interval -2.56 to 4.23	—

SECONDARY outcome

Timeframe: From AI commencement to month 12 of AI therapy

Population: Patients with LS BMD measurements both at AI commencement and at 12 months of AI therapy.

Outcome measures

Outcome measures
Measure	CT Cohort 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.	HT Cohort n=123 Participants In the HT cohort patients were treated with a third generation AI, as adjuvant therapy (HT cohort) and were followed up for a 12-month period. 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. BMD measurements in HT cohort were taken before AI start and at 12 months.
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	—	1.51 percentage of change Interval -0.96 to 3.18

SECONDARY outcome

Timeframe: From AI commencement to month 12 of AI therapy

Population: Patients with HIP BMD measurements both at AI commencement and at 12 months of AI therapy.

Outcome measures

Outcome measures
Measure	CT Cohort 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.	HT Cohort n=123 Participants In the HT cohort patients were treated with a third generation AI, as adjuvant therapy (HT cohort) and were followed up for a 12-month period. 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. BMD measurements in HT cohort were taken before AI start and at 12 months.
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	—	-0.94 percentage of change Interval -2.58 to 0.7

SECONDARY outcome

Timeframe: During the 12 months of AI Therapy

Population: All patients with available 12 month follow-up during AI treatment

Outcome measures

Outcome measures
Measure	CT Cohort n=86 Participants 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.	HT Cohort n=123 Participants In the HT cohort patients were treated with a third generation AI, as adjuvant therapy (HT cohort) and were followed up for a 12-month period. 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. BMD measurements in HT cohort were taken before AI start and at 12 months.
Bone Fracture Rate	0 participants	0 participants

SECONDARY outcome

Timeframe: Baseline and month 1-6 (depending on duration of chemotherapy)

Population: Patients with LS BMD measurements both at baseline (before chemotherapy commencement) and at chemotherapy completion

Outcome measures

Outcome measures
Measure	CT Cohort n=86 Participants 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.	HT Cohort In the HT cohort patients were treated with a third generation AI, as adjuvant therapy (HT cohort) and were followed up for a 12-month period. 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. BMD measurements in HT cohort were taken before AI start and at 12 months.
Mean Percentage Change in Lumbar Spine Bone Mineral Density From Baseline (Before Chemotherapy Commencement) to Chemotherapy Completion	-0.19 percentage of change Interval -2.12 to 1.74	—

SECONDARY outcome

Timeframe: Month 1-6 (depending on duration of chemotherapy) and month 13-18

Population: Patients with LS BMD measurements both at AI commencement and at 12 months of AI therapy.

Outcome measures

Outcome measures
Measure	CT Cohort n=86 Participants 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.	HT Cohort In the HT cohort patients were treated with a third generation AI, as adjuvant therapy (HT cohort) and were followed up for a 12-month period. 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. BMD measurements in HT cohort were taken before AI start and at 12 months.
Mean Percentage Change in Lumbar Spine Bone Mineral Density From AI Commencement to Month 12 of Therapy.	-0.59 percentage of change Interval -3.18 to 2.0	—

Adverse Events

CT Cohort

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

HT Cohort

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Christos J Markopoulos, MD, MPhil Professor of Surgery-Athens University Medical School

Hellenic Society of Breast Surgeons

Phone: +30 210 6862527

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place