Breast Cancer With Metastatic Bone DiseasePhase 4NCT00172029
Study Comparing Full-dose Radiotherapy Versus Reduced Dose in the Management of Bone Metastasis in Patients With Breast Cancer Receiving Zoledronic Acid
A Phase 4 study testing Zoledronic acid in people with Breast Cancer With Metastatic Bone Disease, run by Novartis at 7 sites in Turkey (Türkiye).
Trial summary
The aim of this prospective, randomized, open-label, multicentric clinical study is to assess the effícacy and tolerability of zoledronic acid 4 mg IV infused over 15 minutes every 4 weeks for a total of 6 infusions, in combination with standard or reduced dose radiotherapy in patients with breast cancer and… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer With Metastatic Bone Disease
- What is being tested?
- Zoledronic acid
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 116 participants
- Where
- 7 sitesTurkey (Türkiye)
- Study dates
- Apr 2003to Sep 2005
- Phase
- Phase 4
- 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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female patients aged ≥ 18 years.
- Histologically confirmed diagnosis of breast cancer with at least one bone metastases.
- Radiologically documented solitary or multiple osteolytic or osteoblastic lesions in axial skeleton or in the extremities in which radiotherapy is indicated.
- Pain and/or analgesic score ≥ 3 (see section 3.5.2) at the bone site to be irradiated.
- ECOG performance status ≤ 2.
- Life expectancy more than 6 months.
Who cannot join
- Patients in whom the target lesion(s) is not detectable by conventional techniques (i.e. X-rays MRI or CT scan).
- Presence of pathological fracture in the target lesion(s).
- Prior irradiation of the painful area(s) to be irradiated.
- Known hypersensitivity to zoledronic acid or other biphosphonates.
- Previous treatment with bisphosphonates for the current disease; any treatment with biphosphonates for other indications should anyway have been discontinued at least two years before randomization into the study.
- Skeleton-related complications (e.g., pathological fractures, orthopedic intervention to treat or stabilize an osteolytic defect, spinal cord compression) during the last 3 weeks prior to the first infusion of trial medication.
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- Change in anticancer therapy within the 2 weeks prior to screening assessments and/or test treatment start.
- Patients with severe renal function (serum creatinine > 400 umol/l or > 4.5 mg/dl or calculated creatinine clearance ≤ 30 ml/minute) or with prior renal transplantation. Creatinine clearance will be calculated using the following formula:
- Creatinine clearance = (140-age[yr])(body weight [kg]) x 0.85 (72) (serum creatinine [mg/dL]) or Creatinine clearance = (140-age[yr])(body weight [kg]) x 0.85 (0.814) (serum creatinine [µmol/L])
- Corrected (adjusted for serum albumin) serum calcium concentration < 8.0 mg/dl (2.00 mmol/L).
- Patients with clinically symptomatic brain metastases
- Bone metabolism disorder, e.g. Paget disease, primary hyperparathyroidism
- Serious intercurrent illness other than breast cancer that can interfere with the evaluation of the effect of the therapy.
- Pregnancy and lactation.
- Women of childbearing potential not on an effective form of contraception.
- Known history or present abuse of alcohol or drugs (accepted social alcohol usage will not exclude the patient)
- Patients who, in the opinion of the investigator, are unlikely to cooperate fully during the study.
- Other protocol-defined inclusion/exclusion criteria may apply.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
Turkey (Türkiye)7 sites
Novartis Investigative Site
Ankara
Novartis Investigative Site
Antalya
Novartis Investigative Site
Bursa
Novartis Investigative Site
Istanbul
Novartis Investigative Site
Izmir
Novartis Investigative Site
Kayseri
Novartis Investigative Site
Trabzon
About this study
The aim of this prospective, randomized, open-label, multicentric clinical study is to assess the effícacy and tolerability of zoledronic acid 4 mg IV infused over 15 minutes every 4 weeks for a total of 6 infusions, in combination with standard or reduced dose radiotherapy in patients with breast cancer and metastatic bone disease associated with pain.
- Being tested
- Zoledronic acid
- Keywords
- Zoledronic acid, Radiotherapy, Bone pain, 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 acidDrug
Also called ZOL446
| Study group | Role | What they receive |
|---|---|---|
| ZOL446 Standard radiotherapy dosage | Experimental | Not described Receives: Drug: Zoledronic acid |
| ZOL446 Low radiotherapy dosage | Experimental | Not described Receives: Drug: Zoledronic acid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of patients showing complete response in bone pain palliation without having any analgesic treatment
Measured: day 5, 12, 29; week 8, 12, 16, 20 & 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2005 (estimated)
- Study startApr 2003
- Primary completionSep 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast Cancer With Metastatic Bone DiseaseStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 116 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00172029
- Sponsor's protocol ID
- CZOL446ETR01
- Status last verified
- Aug 2023
- First submitted
- 13 Sep 2005
- Last updated
- 18 Aug 2023
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study Comparing Full-dose Radiotherapy Versus Reduced Dose in the Management of Bone Metastasis in Patients With Breast Cancer Receiving Zoledronic Acid
- ClinicalTrials.gov ID
- NCT00172029
- Acronym / sponsor ID
- CZOL446ETR01
- Keywords
- Zoledronic acid, Radiotherapy, Bone pain, Breast cancer
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 116 participants (actual)
- Lead sponsor
- NovartisIndustry (pharma, biotech, devices)
- Study start
- Apr 2003
- Primary completion
- Sep 2005 (actual)
- First posted
- 15 Sep 2005 (estimated)
- 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 aim of this prospective, randomized, open-label, multicentric clinical study is to assess the effícacy and tolerability of zoledronic acid 4 mg IV infused over 15 minutes every 4 weeks for a total of 6 infusions, in combination with standard or reduced dose radiotherapy in patients with breast cancer and metastatic bone disease associated with pain.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ZOL446 Standard radiotherapy dosage | Experimental | Drug: Zoledronic acid |
| ZOL446 Low radiotherapy dosage | Experimental | Drug: Zoledronic acid |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Female patients aged ≥ 18 years.
- Histologically confirmed diagnosis of breast cancer with at least one bone metastases.
- Radiologically documented solitary or multiple osteolytic or osteoblastic lesions in axial skeleton or in the extremities in which radiotherapy is indicated.
- Pain and/or analgesic score ≥ 3 (see section 3.5.2) at the bone site to be irradiated.
- ECOG performance status ≤ 2.
Key exclusion criteria (18 listed)
- Patients in whom the target lesion(s) is not detectable by conventional techniques (i.e. X-rays MRI or CT scan).
- Presence of pathological fracture in the target lesion(s).
- Prior irradiation of the painful area(s) to be irradiated.
- Known hypersensitivity to zoledronic acid or other biphosphonates.
- Previous treatment with bisphosphonates for the current disease; any treatment with biphosphonates for other indications should anyway have been discontinued at least two years before randomization into the study.
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 acidAlso: ZOL446 | Drug | ZOL446 Low radiotherapy dosage, ZOL446 Standard radiotherapy dosage |
Primary outcome
Percentage of patients showing complete response in bone pain palliation without having any analgesic treatment
Time frame: day 5, 12, 29; week 8, 12, 16, 20 & 24
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2023.
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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.
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Zoledronic acid in people with Breast Cancer With Metastatic Bone Disease, run by Novartis at 7 sites in Turkey (Türkiye).
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 6 inclusion and 18 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: finished, as of the sponsor's last update on 18 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Turkey (Türkiye). 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of patients showing complete response in bone pain palliation without having any analgesic treatment (time frame: day 5, 12, 29; week 8, 12, 16, 20 & 24). 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 18 Aug 2023.