Primary Breast CancerPhase 2MRD-1NCT00172068
Zoledronic Acid in the Treatment of Breast Cancer With Minimal Residual Disease in the Bone Marrow
A Phase 2 study testing Zoledronic acid + Calcium/Vitamin D in people with Primary Breast Cancer, run by Novartis Pharmaceuticals at 4 sites in Germany.
Trial summary
Metastatic bone disease is an important prognostic factor for survival which will in median be close to two years after first diagnosis of osseous metastases. This open-label study will investigate the safety and efficacy of zoledronic acid in patients with breast cancer and minimal residual disease in the bone marrow. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Primary Breast Cancer
- What is being tested?
- Zoledronic acid + Calcium/Vitamin D
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 4 sitesGermany
- Study dates
- Jan 2002to Nov 2008
- Phase
- Phase 2
- 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
- Patients, with primary breast cancer who had undergone complete primary tumor resection and axillary lymph node dissection
- Evidence of minimal residual disease (disseminated tumor cells in bone marrow)
- Patients had to receive one of the following adjuvant therapy categories: chemotherapy ± hormonal therapy or hormonal therapy alone
Who cannot join
- Inflammatory, metastatic or recurrent breast cancer or a history of breast cancer prior to the currently diagnosed case
- Neo-adjuvant chemotherapy, neo-adjuvant hormonal therapy, or neo-adjuvant radiotherapy
- Prior stem cell rescue/bone marrow transplant
- History of other cancers aside from non-melanomatous skin cancer or carcinoma in situ of the uterine cervix
- Additional protocol-defined inclusion / exclusion criteria may apply
Trial locations and contacts
4 sites in 1 country.
Germany4 sites
Novartis Invstigative Site
Bielefeld
Novartis Investigative Site
Hanover
Novartis Investigative Site
München
Novartis Investigative Site
Tübingen
About this study
Official title: Efficacy and Tolerability of Intravenous Zometa® (Zoledronic Acid) 4 mg in Primary Breast Cancer Patients With Disseminated Tumor Cells in Bone Marrow. A Prospective, Randomized, Parallel Group, Open-label, Clinical Pilot Study.
Metastatic bone disease is an important prognostic factor for survival which will in median be close to two years after first diagnosis of osseous metastases. This open-label study will investigate the safety and efficacy of zoledronic acid in patients with breast cancer and minimal residual disease in the bone marrow.
- Conditions
- Primary Breast Cancer
- Being tested
- Zoledronic acid + Calcium/Vitamin D
- Keywords
- Primary breast cancer, Bone metastases, Minimal residual disease, Bisphosphonates
- Medical subject headings
- Neoplasm, Residual
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Zoledronic acid + Calcium/Vitamin DDrug
| Study group | Role | What they receive |
|---|---|---|
| Treatment Group | Experimental | Not described Receives: Drug: Zoledronic acid + Calcium/Vitamin D |
| Control Group | Active comparator | Not described Receives: Drug: Zoledronic acid + Calcium/Vitamin D |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction of detected tumor cells in bone marrow
Measured: 12 months
Secondary outcomes (5)
Tumor cell detection in bone marrow in comparison to the time point of primary surgery (Baseline).
Measured: 24 months
Bone metastases-free survival
Measured: 24 months
Disease-free survival
Measured: 24 months
Bone mineral density
Measured: at 12 and 24 months
Number and localization of bone metastases
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 posted15 Sep 2005 (estimated)
- Study startJan 2002
- Primary completionNov 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Primary Breast CancerStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmeceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00172068
- Sponsor's protocol ID
- CZOL446GDE05
- Acronym
- MRD-1
- Status last verified
- Dec 2009
- First submitted
- 13 Sep 2005
- Last updated
- 23 Dec 2009
- Results posted
- No
Publications
Adams A, Jakob T, Huth A, Monsef I, Ernst M, Kopp M, Caro-Valenzuela J, Wockel A, Skoetz N. Bone-modifying agents for reducing bone loss in women with early and locally advanced breast cancer: a network meta-analysis. Cochrane Database Syst Rev. 2024 Jul 9;7(7):CD013451. doi: 10.1002/14651858.CD013451.pub2.
PubMed 38979716Banys M, Solomayer EF, Gebauer G, Janni W, Krawczyk N, Lueck HJ, Becker S, Huober J, Kraemer B, Wackwitz B, Hirnle P, Wallwiener D, Fehm T. Influence of zoledronic acid on disseminated tumor cells in bone marrow and survival: results of a prospective clinical trial. BMC Cancer. 2013 Oct 15;13:480. doi: 10.1186/1471-2407-13-480.
PubMed 24128322
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Tolerability of Intravenous Zometa® (Zoledronic Acid) 4 mg in Primary Breast Cancer Patients With Disseminated Tumor Cells in Bone Marrow. A Prospective, Randomized, Parallel Group, Open-label, Clinical Pilot Study.
- ClinicalTrials.gov ID
- NCT00172068
- Acronym / sponsor ID
- MRD-1 / CZOL446GDE05
- Conditions
- Primary Breast Cancer
- Keywords
- Primary breast cancer, Bone metastases, Minimal residual disease, Bisphosphonates
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 96 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Jan 2002
- Primary completion
- Nov 2008 (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.
Metastatic bone disease is an important prognostic factor for survival which will in median be close to two years after first diagnosis of osseous metastases. This open-label study will investigate the safety and efficacy of zoledronic acid in patients with breast cancer and minimal residual disease in the bone marrow.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment Group | Experimental | Drug: Zoledronic acid + Calcium/Vitamin D |
| Control Group | Active comparator | Drug: Zoledronic acid + Calcium/Vitamin D |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients, with primary breast cancer who had undergone complete primary tumor resection and axillary lymph node dissection
- Evidence of minimal residual disease (disseminated tumor cells in bone marrow)
- Patients had to receive one of the following adjuvant therapy categories: chemotherapy ± hormonal therapy or hormonal therapy alone
Key exclusion criteria (5 listed)
- Inflammatory, metastatic or recurrent breast cancer or a history of breast cancer prior to the currently diagnosed case
- Neo-adjuvant chemotherapy, neo-adjuvant hormonal therapy, or neo-adjuvant radiotherapy
- Prior stem cell rescue/bone marrow transplant
- History of other cancers aside from non-melanomatous skin cancer or carcinoma in situ of the uterine cervix
- Additional protocol-defined inclusion / exclusion criteria may apply
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 + Calcium/Vitamin D | Drug | Control Group, Treatment Group |
Primary outcome
Reduction of detected tumor cells in bone marrow
Time frame: 12 months
5 secondary outcomes
Tumor cell detection in bone marrow in comparison to the time point of primary surgery (Baseline).
Time frame: 24 months
Bone metastases-free survival
Time frame: 24 months
Disease-free survival
Time frame: 24 months
Bone mineral density
Time frame: at 12 and 24 months
Number and localization of bone metastases
Time frame: 24 months
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Dec 2009.
- Derived from this study: PubMed 38979716Adams A, Jakob T, Huth A, Monsef I, Ernst M, Kopp M, Caro-Valenzuela J, Wockel A, Skoetz N. Bone-modifying agents for reducing bone loss in women with early and locally advanced breast cancer: a network meta-analysis. Cochrane Database Syst Rev. 2024 Jul 9;7(7):CD013451. doi: 10.1002/14651858.CD013451.pub2.
- Derived from this study: PubMed 24128322Banys M, Solomayer EF, Gebauer G, Janni W, Krawczyk N, Lueck HJ, Becker S, Huober J, Kraemer B, Wackwitz B, Hirnle P, Wallwiener D, Fehm T. Influence of zoledronic acid on disseminated tumor cells in bone marrow and survival: results of a prospective clinical trial. BMC Cancer. 2013 Oct 15;13:480. doi: 10.1186/1471-2407-13-480.
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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 Pharmeceuticals
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Zoledronic acid + Calcium/Vitamin D in people with Primary Breast Cancer, run by Novartis Pharmaceuticals at 4 sites in Germany.
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 3 inclusion and 5 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: stopped early, as of the sponsor's last update on 23 Dec 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Germany. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 was stopped early. Results are not available in the source record.
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?
Reduction of detected tumor cells in bone marrow (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00172068, which also lists 2 linked publications.
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 23 Dec 2009.