Delayed Versus Immediate Use Of Zoledronic Acid For Postmenopausal Patients With Early Breast Cancer Who Are Using Adjuvant Letrozole

Phase 3

• Conditions: Use of Zoledronic Acid in Breast Cancer
• Interventions: Drug: Zoledronic Acid 4 MG

• Registration Number: NCT05164952
• Lead Sponsor: Assiut University

Brief Summary

The investigators will involve about 25 Patients of postmenopausal women who have ER/PR positive early breast cancer in each arm.

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

The investigators will involve about 25 Patients of postmenopausal women who have ER/PR positive early breast cancer in each arm.

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.

Study Timeline

• Study Start: 2021-09-30
• Study First Submitted: 2021-10-13
• Status Verified: 2021-12
• Study First Submitted QC: 2021-12-05
• Last Update Submitted: 2021-12-05
• Study First Posted: 2021-12-21
• Last Update Posted: 2021-12-21
• Primary Completion: 2023-08-30
• Study Completion: 2023-09-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 50

Inclusion Criteria

1. Histologic evidence of ER/PR positive breast adenocarcinoma
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

1. Patients with dental problems.
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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Immediate use of zoledronic acid arm	Zoledronic Acid 4 MG	Immediate-ZOL patients will receive ZOL immediately after randomization
Delayed use of zoledronic acid arm	Zoledronic Acid 4 MG	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.

Primary Outcome Measures

Name	Time	Method
The percentage change in lumber spine (L2-L4) BMD at 12 and 24 months for immediate- versus delayed-ZOL patients.	24 months	The percentage change in lumber spine (L2-L4) BMD at 12 and 24 months for immediate- versus delayed-ZOL patients.

Secondary Outcome Measures

Name	Time	Method
percentage change in total hip BMD at each assessment, fracture incidence in percentage, time to disease recurrence in months (local relapse or distant metastasis), DFS in months, and safety.	24 months	percentage change in total hip BMD at each assessment, fracture incidence in percentage, time to disease recurrence in months (local relapse or distant metastasis), DFS in months, and safety.
Fracture incidence in percentage	24 months	Assessment of incidence fracture in the participants

Trial Locations

Locations (1)

Clinical Oncology Department, Assuit University Hospital; 🇪🇬 Asyūţ, Asyut, Egypt