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

Sponsor
Assiut University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05164952
Collaborator
(none)
50
Enrollment
1
Location
2
Arms
24
Anticipated Duration (Months)
2.1
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Zoledronic Acid 4 MG
 Phase 3

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 Design

Study Type:
Interventional
Anticipated Enrollment :
50 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Delayed Versus Immediate Use Of Zoledronic Acid For Postmenopausal Patients With ER/PR Positive Early Breast Cancer Who Are Using Adjuvant Letrozole
Actual Study Start Date :
Sep 30, 2021
Anticipated Primary Completion Date :
Aug 30, 2023
Anticipated Study Completion Date :
Sep 30, 2023

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. 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

    1. 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.

    2. Fracture incidence in percentage [24 months]

      Assessment of incidence fracture in the participants

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    45 Years to 80 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Clinical Oncology Department, Assuit University Hospital Asyūţ Asyut Egypt 1111

    Sponsors and Collaborators

    • Assiut University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    MAI MOHAMED HEMMAT ABDELFATAH ABDELGELIL, Assistant Lecturer of Clinical Oncology, Assiut University
    ClinicalTrials.gov Identifier:
    NCT05164952
    Other Study ID Numbers:
    • Zoledronic Acid In Breast Ca
    First Posted:
    Dec 21, 2021
    Last Update Posted:
    Dec 21, 2021
    Last Verified:
    Dec 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    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
    Keywords provided by MAI MOHAMED HEMMAT ABDELFATAH ABDELGELIL, Assistant Lecturer of Clinical Oncology, Assiut University
    Breast cancer
    Additional relevant MeSH terms:
    Breast Neoplasms
    Zoledronic Acid

    Study Results

    No Results Posted as of Dec 21, 2021