Assessment of the efficacy of the use of zoledronic acid in the prevention of aromatase inhibitor-associated bone loss in postmenopausal women with hormone receptor-positive breast cancer who received letrozole as adjuvant therapy

• Register: JPRN
• Last refreshed on: 17 October 2023
• Main ID: JPRN-UMIN000001104
• Date of registration: 29/03/2008
• Prospective Registration: No
• Primary sponsor: Cancer Institute Hospital
• Public title: Assessment of the efficacy of the use of zoledronic acid in the prevention of aromatase inhibitor-associated bone loss in postmenopausal women with hormone receptor-positive breast cancer who received letrozole as adjuvant therapy
• Scientific title: Assessment of the efficacy of the use of zoledronic acid in the prevention of aromatase inhibitor-associated bone loss in postmenopausal women with hormone receptor-positive breast cancer who received letrozole as adjuvant therapy - Z-FAST Study_Japan
• Date of first enrolment: 2008/03/01
• Target sample size: 180
• Recruitment status: Complete: follow-up continuing
• URL: https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001335
• Study type: Interventional
• Study design: Parallel Randomized
• Phase: Phase II

Countries of recruitment

Japan

Contacts

• Name: Shinzaburo Noguchi
• Affiliation: Graduate School of Medicine, Osaka University Department of Breast and Endocrine Surgery

• Name: Shunji Takahashi
• Affiliation: Cancer Institute Hospital Division of Medical Oncology

Key inclusion & exclusion criteria

Inclusion criteria:
Exclusion criteria: 1)Patients with any clinical or radiological evidence of distant spread of their disease at any point before randomization 2)Patients with invasive bilateral breast cancer 3)Patients who have started adjuvant endocrine therapy 4)Patients who have received any endocrine therapy within the past 12 months 5)Patients who have received prior treatment with intravenous bisphosphonates within the past 12 months 6)Patients with the following diseases which may interfere with DXA scan: severe scoliosis, immobility, hyperosteosis or sclerotic changes at the lumbar spine, calcification of abdominal aorta, vertebral diseases 7)Patients with previous or concomitant malignancy (not breast cancer) within the past 5 years 8)Current active dental problems including infection of the teeth or jawbone. Recent (within 6 weeks) or planned dental or jaw surgery(e.g., extraction, implants) 9)Other conditions judged as inappropriate for the study by the investigator

Age minimum: Not applicable
Age maximum: Not applicable
Gender: Female

Health Condition(s) or Problem(s) studied

Postmenopausal Breast Cancer

Intervention(s)

All patients receive letrozole 2.5 mg orally daily for 5 years or until disease progression.
Patients receive zoledronic acid 4mg or an adjusted dose based on renal function IV over 15 minutes infusion every 6 months for 5 years. The Upfront group receives zoledronic acid after random assignment, whereas the delayed group receives zoledronic acid when either postbaseline lumber spine BMD decreases to YAM -2.0 SD or clinical fracture occurred.

Primary Outcome(s)

To compare the percent change in the lumbar spine(L1-L4)BMD, as measured by DXA, at 12 months in postmenopausal women with hormone receptor-positive breast cancer randomized to zoledronic acid upfront versus delayed start.

Secondary Outcome(s)

1)To compare the percent change in lumbar spine(L1-L4)BMD at two years, three years, four years and five years between the two treatment groups. 2)To compare the percent change in total hip BMD at 12 months, two years, three years, four years and five years between the two treatment groups. 3)To identify changes in serum markers of bone turnover, serum NTX and BSAP, at 12 months, two years, three years, four years and five years. 4)To compare the incidence rate of all clinical fractures at three years between the two treatment groups. 5)To compare the profile of serum lipids. 6)To compare the time to disease progression between the two treatment groups. 7)To compare the overall survival between the two treatment groups. 8)Adverse events

Source(s) of Monetary Support

None

Ethics review

Status: YES
Approval date:
Contact:

Results

• Results available: Yes
• Date Completed: 01/12/2014
• URL: http://www.asco.org/ASCOv2/Meetings/Abstracts?&vmview=abst_detail_view&confID=102&abstractID=77433