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

NCT05164952 | Unknown Phase 3 FDA Drug

• 1 other identifier: Zoledronic Acid In Breast Ca
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Use of Zoledronic Acid in Breast Cancer

Keywords

Breast cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• 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

  24 months

Study Arms (2)

Delayed use of zoledronic acid arm

EXPERIMENTAL

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

Immediate use of zoledronic acid arm

EXPERIMENTAL

Immediate-ZOL patients will receive ZOL immediately after randomization

Drug: Zoledronic Acid 4 MG

Interventions

Zoledronic Acid 4 MG DRUG

(4 mg via 15-min infusion every 6 months) for 24 months

Also known as: Zometa

Delayed use of zoledronic acid arm; Immediate use of zoledronic acid arm

Eligibility Criteria

• Age: 45 Years - 80 Years
• Gender Eligibility Details: Postmenpausal women with ER/PR positive early breast cancer who are using adjuvant Letrozole
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologic evidence of ER/PR positive breast adenocarcinoma
• Postmenopausal women.
• Baseline LS and total hip BMD T-score \> -2.0.
• No prior treatment with denosumab or IV bisphosphonates is allowed.
• No prior treatment with radiopharmaceuticals.
• Not pregnant and not nursing.
• Good dental health.
• ECOG performance status 0-2.
• Calculated creatinine clearance \>= 30 mL/min.
• Corrected serum calcium \>= 8.0 mg/dL (2.00 mmol/L) and \< 11.6 mg/dL (2.90 mmol/L)

You may not qualify if:

• Patients with dental problems.
• Patients with impaired renal functions
• Patients with osteopenia, or T- score is below -2.0
• Patients with history of serious drug hypersensitivity or drug allergy.

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Clinical Oncology Department, Assuit University Hospital

Asyut, Asyut Governorate, 1111, Egypt

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Zoledronic Acid

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Diphosphonates; Organophosphonates; Organophosphorus Compounds; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Central Study Contacts

Mai Abdelgelil, Assistant Lecturer Of Clinical

CONTACT

00201026556852; maihemmat86@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Lecturer of Clinical Oncology

Study Record Dates

• First Submitted: October 13, 2021
• First Posted: December 21, 2021
• Study Start: September 30, 2021
• Primary Completion: August 30, 2023
• Study Completion: September 30, 2023
• Last Updated: December 21, 2021

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: 18 months

Locations

EG (1)