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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Use of Zoledronic Acid in Breast Cancer
• Intervention / Treatment: Drug: Zoledronic Acid 4 MG

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 Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Mai Abdelgelil, Assistant Lecturer Of Clinical; Phone Number: 42268 00201026556852; Email: maihemmat86@gmail.com

Study Locations

• Egypt
  • Asyut
    • Asyūţ, Asyut, Egypt, 1111
      • Recruiting
      • Clinical Oncology Department, Assuit University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Drug: Zoledronic Acid 4 MG; (4 mg via 15-min infusion every 6 months) for 24 months; Other Names: Zometa
Experimental: Immediate use of zoledronic acid arm; Immediate-ZOL patients will receive ZOL immediately after randomization	Drug: Zoledronic Acid 4 MG; (4 mg via 15-min infusion every 6 months) for 24 months; Other Names: Zometa

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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
Fracture incidence in percentage	Assessment of incidence fracture in the participants	24 months

Collaborators and Investigators

• Sponsor: Assiut University

Study record dates

Study Major Dates

• Study Start (Actual): September 30, 2021
• Primary Completion (Anticipated): August 30, 2023
• Study Completion (Anticipated): September 30, 2023

Study Registration Dates

• First Submitted: October 13, 2021
• First Submitted That Met QC Criteria: December 5, 2021
• First Posted (Actual): December 21, 2021

Study Record Updates

• Last Update Posted (Actual): December 21, 2021
• Last Update Submitted That Met QC Criteria: December 5, 2021
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Keywords: Breast cancer
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms; Physiological Effects of Drugs; Bone Density Conservation Agents; Zoledronic Acid
• Other Study ID Numbers: Zoledronic Acid In Breast Ca

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Sharing Time Frame: 18 months
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP); Informed Consent Form (ICF)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes