Use of Zoledronic Acid in Breast CancerPhase 3NCT05164952
Delayed Versus Immediate Use Of Zoledronic Acid For Postmenopausal Patients With Early Breast Cancer Who Are Using Adjuvant Letrozole
A Phase 3 study testing Zoledronic Acid 4 MG in people with Use of Zoledronic Acid in Breast Cancer, run by Assiut University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 45 to 80 years, women only
- Conditions the study is for
- Use of Zoledronic Acid in Breast Cancer
- What is being tested?
- Zoledronic Acid 4 MG
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 30 Sep 2021to 30 Sep 2023
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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)
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Mai Abdelgelil, Assistant Lecturer Of Clinical contact
Egypt1 site, 1 recruiting
- Recruiting
Clinical Oncology Department, Assuit University Hospital
Asyut, Asyut Governorate, 1111
About this study
Official title: 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.
Read the 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:
- 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.
- 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
- Use of Zoledronic Acid in Breast Cancer
- Being tested
- Zoledronic Acid 4 MG
- Keywords
- Breast cancer
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Zoledronic Acid 4 MGDrug
Also called Zometa
(4 mg via 15-min infusion every 6 months) for 24 months
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Zoledronic Acid 4 MG |
| Immediate use of zoledronic acid arm | Experimental | Immediate-ZOL patients will receive ZOL immediately after randomization Receives: Drug: Zoledronic Acid 4 MG |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
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.
Measured: 24 months
Fracture incidence in percentage
Assessment of incidence fracture in the participants
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2021
- Study start30 Sep 2021
- Primary completion30 Aug 2023 (estimated)
- Study completion30 Sep 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Use of Zoledronic Acid in Breast CancerStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, MAI MOHAMED HEMMAT ABDELFATAH ABDELGELIL, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05164952
- Sponsor's protocol ID
- Zoledronic Acid In Breast Ca
- Status last verified
- Dec 2021
- First submitted
- 13 Oct 2021
- Last updated
- 21 Dec 2021
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Delayed Versus Immediate Use Of Zoledronic Acid For Postmenopausal Patients With ER/PR Positive Early Breast Cancer Who Are Using Adjuvant Letrozole
- ClinicalTrials.gov ID
- NCT05164952
- Acronym / sponsor ID
- Zoledronic Acid In Breast Ca
- Conditions
- Use of Zoledronic Acid in Breast Cancer
- Keywords
- Breast cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 30 Sep 2021 (actual)
- Primary completion
- 30 Aug 2023 (estimated)
- Study completion
- 30 Sep 2023 (estimated)
- First posted
- 21 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
- 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Delayed use of zoledronic acid arm | Experimental | Drug: Zoledronic Acid 4 MGdelayed-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. |
| Immediate use of zoledronic acid arm | Experimental | Drug: Zoledronic Acid 4 MGImmediate-ZOL patients will receive ZOL immediately after randomization |
Who may qualify
- Ages
- 45 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Zoledronic Acid 4 MGAlso: Zometa(4 mg via 15-min infusion every 6 months) for 24 months | Drug | Delayed use of zoledronic acid arm, Immediate use of zoledronic acid arm |
Primary outcome
The percentage change in lumber spine (L2-L4) BMD at 12 and 24 months for immediate- versus delayed-ZOL patients.
Time frame: 24 months
The percentage change in lumber spine (L2-L4) BMD at 12 and 24 months for immediate- versus delayed-ZOL patients.
2 secondary outcomes
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.
Time frame: 24 months
Fracture incidence in percentage
Time frame: 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Dec 2021.
- Individual participant dataSharing planned: Yes
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mai Abdelgelil, Assistant Lecturer Of Clinical contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Zoledronic Acid 4 MG in people with Use of Zoledronic Acid in Breast Cancer, run by Assiut University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mai Abdelgelil, Assistant Lecturer Of Clinical (00201026556852 ext. 42268, maihemmat86@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The percentage change in lumber spine (L2-L4) BMD at 12 and 24 months for immediate- versus delayed-ZOL patients. (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Dec 2021.