Delayed Versus Immediate Use Of Zoledronic Acid For Postmenopausal Patients With Early Breast Cancer Who Are Using Adjuvant Letrozole
NCT ID: NCT05164952
Last Updated: 2021-12-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
50 participants
INTERVENTIONAL
2021-09-30
2023-09-30
Brief Summary
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The study is a two-arm comparative, prospective, interventional, and randomized study. All patients who are on oral daily letrozole (2.5 mg), will be randomly assigned to receive either immediate or delayed ZOL (4 mg via 15-min infusion every 6 months) for 24 months. Immediate-ZOL patients will receive ZOL immediately after randomization; delayed-ZOL patients will receive ZOL only if their T-score fall below -2.0, after a nontraumatic clinical fracture, or if an asymptomatic fracture will be detected by spinal X-ray at the 3- monthly assessment. All patients will receive daily supplements containing calcium (500 mg) and vitamin D (400-800 IU). Baseline bone mineral density and every 3 months will be done for the enrolled patients.
Detailed Description
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The study is a two-arm comparative, prospective, interventional, and randomized study. All patients who are on oral daily letrozole (2.5 mg), will be randomly assigned to receive either immediate or delayed ZOL (4 mg via 15-min infusion every 6 months) for 24 months. Immediate-ZOL patients will receive ZOL immediately after randomization; delayed-ZOL patients will receive ZOL only if their T-score fall below -2.0, after a nontraumatic clinical fracture, or if an asymptomatic fracture will be detected by spinal X-ray at the 3- monthly assessment. All patients will receive daily supplements containing calcium (500 mg) and vitamin D (400-800 IU). Baseline bone mineral density and every 3 months will be done for the enrolled patients.
-Research outcome measures:
1. Primary (main): The primary endpoint will be the percentage change in lumber spine (L2-L4) BMD at 12 months for immediate- versus delayed-ZOL patients.
2. Secondary (subsidiary): Secondary end points will include percentage change in total hip BMD at each assessment, fracture incidence, time to disease recurrence (local relapse or distant metastasis), DFS, and safety.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Delayed use of zoledronic acid arm
delayed-ZOL patients will receive ZOL only if their T-score fall below -2.0, after a nontraumatic clinical fracture, or if an asymptomatic fracture will be detected by spinal X-ray at the 3- monthly assessment.
Zoledronic Acid 4 MG
(4 mg via 15-min infusion every 6 months) for 24 months
Immediate use of zoledronic acid arm
Immediate-ZOL patients will receive ZOL immediately after randomization
Zoledronic Acid 4 MG
(4 mg via 15-min infusion every 6 months) for 24 months
Interventions
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Zoledronic Acid 4 MG
(4 mg via 15-min infusion every 6 months) for 24 months
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Postmenopausal women.
3. Baseline LS and total hip BMD T-score \> -2.0.
4. No prior treatment with denosumab or IV bisphosphonates is allowed.
5. No prior treatment with radiopharmaceuticals.
6. Not pregnant and not nursing.
7. Good dental health.
8. ECOG performance status 0-2.
9. Calculated creatinine clearance \>= 30 mL/min.
10. Corrected serum calcium \>= 8.0 mg/dL (2.00 mmol/L) and \< 11.6 mg/dL (2.90 mmol/L)
Exclusion Criteria
2. Patients with impaired renal functions
3. Patients with osteopenia, or T- score is below -2.0
4. Patients with history of serious drug hypersensitivity or drug allergy.
45 Years
80 Years
FEMALE
No
Sponsors
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Assiut University
OTHER
Responsible Party
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MAI MOHAMED HEMMAT ABDELFATAH ABDELGELIL
Assistant Lecturer of Clinical Oncology
Locations
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Clinical Oncology Department, Assuit University Hospital
Asyut, Asyut Governorate, Egypt
Countries
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Central Contacts
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Mai Abdelgelil, Assistant Lecturer Of Clinical
Role: CONTACT
Phone: 00201026556852
Email: [email protected]
Other Identifiers
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Zoledronic Acid In Breast Ca
Identifier Type: -
Identifier Source: org_study_id