Early Primary Breast CancerPhase 3NCT03385200
KVUS at Neoadjuvant CTx of Breast Cancer
A Phase 3 study testing SonoVue in people with Early Primary Breast Cancer, run by RWTH Aachen University at 1 site in Germany.
Trial summary
Effect of the contrast-enhanced diagnostic ultrasound during neoadjuvant chemotherapy of breast cancer on the achieved tumor size reduction and tolerability of chemotherapy Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Early Primary Breast Cancer
- What is being tested?
- SonoVue
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteGermany
- Study dates
- 12 Dec 2016to 12 Dec 2019
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- written informed consent
- age > 18 yrs
- histologically confirmed primary breast cancer including all intrinsic subtypes
- treatment with neoadjuvant chemotherapy
- persons who are legally competent and mentally able to follow the instructions of the study team
Who cannot join
- hypersensitivity / allergy to sulfur hexafluoride, Macrogol 4000, distearoylphosphatidylcholine, dipalmitoylphosphatidylglycerol-sodium, palmitic acid
- right-left shunt,
- severe pulmonary hypertension (pulmonary arterial pressure > 90 mmHg)
- uncontrolled systemic hypertension
- acute respiratory distress syndrome
- pregnancy
Show all 10Show fewer
- commitment of the patient to any resident institution by order of any court or authority
- expectation of missing compliance
- alcohol or drug abuse
- patients who are in a relationship of dependence or in a working relationship to the sponsor, the investigator or his representative
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Department of Gynecology and Obstetrics
Aachen
Elmar Stickeler, Univ.-Prof. Dr. med., +49 241 80 88400, estickeler@ukaachen.de
About this study
Official title: Contrast-enhanced Ultrasound in Neoadjuvant Chemotherapy of Breast Cancer
Effect of the contrast-enhanced diagnostic ultrasound during neoadjuvant chemotherapy of breast cancer on the achieved tumor size reduction and tolerability of chemotherapy
Read the detailed description
The 5-year survival rate of breast cancer patients is decreasing in the advanced, metastatic stage from 99% to 26%. Therefore an optimization of the therapy of advanced breast cancer is urgently needed.
To increase the echogenicity of the blood in the ultrasound, microbubbles were developed working as stable, biocompatible contrast agent in ultrasound. Such a clinically approved ultrasound contrast agent is SonoVue® (Bracco International B.V., Amsterdam). SonoVue® is approved by the European Medicines Agency (EMA) (approval number EU/1/01/177/002) for the visualization of focal vascularization lesions of the liver and breast within Doppler sonography and is applied in breast cancer patients primarily for the purpose of diagnosis as well as to evaluate the response to the neoadjuvant used chemotherapy.
Animal studies using the contrast enhanced ultrasound have shown that the administration of this contrast agent increases the penetration and accumulation of drugs in the tumor as well as the permeability of the blood-brain barrier resulting in a precise and effective drug distribution. In the tumor animal model it could be shown that a combined treatment with chemotherapy and contrast enhanced ultrasound results in a decreased tumor growth and a prolonged survival. Patients with inoperable pancreatic cancer showed a reduced tumor growth and better tolerability of chemotherapy when administrating the contrast enhanced diagnostic ultrasound during palliative chemotherapy. This could be due to the better tumor response, but also due to the more targeted chemotherapy distribution.
The purpose of this study is to examine whether the use of the contrast enhanced diagnostic ultrasound during neoadjuvant chemotherapy results in an increased tumor regression in comparison to native ultrasound. It is an Investigator Initiated Trial and is funded by internal means.
- Conditions
- Early Primary Breast Cancer
- Being tested
- SonoVue
- Keywords
- breast cancer, neoadjuvant chemotherapy, ultrasound, microbubbles
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SonoVueDrug
As part of the study therapy supportive ultrasound will be performed with iv Infusion of the chemotherapeutic agent.
| Study group | Role | What they receive |
|---|---|---|
| A | Active comparator | Application and measurement of tumor size using contrast agent-enhanced diagnostic and therapy supporting (with SonoVue®) ultrasound Receives: Drug: SonoVue |
| B | No intervention | Application and measurement of tumor size using contrast agent-enhanced diagnostic ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tumor size reduction (1)
pCR (pathohistological complete remission)
Measured: 18 / 24 weeks
Tumor size reduction (2)
cCR (clinical complete remission)
Measured: 18 / 24 weeks
Tumor size reduction (3)
measured by ultrasound (% reduction in therapy)
Measured: 18 / 24 weeks
Secondary outcomes (5)
proliferation rate of the tumor cells
Ki67 protein analysis
Measured: 18 / 24 weeks
narrowing the invasion front of the tumors
ultrasound
Measured: 18 / 24 weeks
macrophage density in the tumor
serum chemistry
Measured: 18 / 24 weeks
vascularization of the tumor
ultrasound
Measured: 18 / 24 weeks
tolerability of chemotherapy
% reduction in therapy
Measured: 18 / 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2017
- Study start12 Dec 2016
- Primary completion12 Jun 2019 (estimated)
- Study completion12 Dec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Early Primary Breast CancerStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parellel Assignment
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- RWTH Aachen University
- Sponsor type
- University, hospital or other
- Collaborators
- Univ.-Prof. Dr. med. F. Kiessling
- Responsible party
- Principal investigator, Elmar Stickeler, RWTH Aachen University
- Investigators
- Elmar Stickeler, niv.-Prof. Dr. med., Principal investigator, Department of Gynecology and Obstetrics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03385200
- Sponsor's protocol ID
- 16-134
- Status last verified
- Dec 2017
- First submitted
- 19 Dec 2017
- Last updated
- 28 Dec 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The study results will be published in at least one scientific article.
Study at a glance
From the registry record, last updated by the sponsor on 28 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Contrast-enhanced Ultrasound in Neoadjuvant Chemotherapy of Breast Cancer
- ClinicalTrials.gov ID
- NCT03385200
- Acronym / sponsor ID
- 16-134
- Conditions
- Early Primary Breast Cancer
- Keywords
- breast cancer, neoadjuvant chemotherapy, ultrasound, microbubbles
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- RWTH Aachen UniversityUniversity, hospital or other
- Collaborators
- Univ.-Prof. Dr. med. F. Kiessling
- Study start
- 12 Dec 2016 (actual)
- Primary completion
- 12 Jun 2019 (estimated)
- Study completion
- 12 Dec 2019 (estimated)
- First posted
- 28 Dec 2017 (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.
Effect of the contrast-enhanced diagnostic ultrasound during neoadjuvant chemotherapy of breast cancer on the achieved tumor size reduction and tolerability of chemotherapy
Detailed description
The 5-year survival rate of breast cancer patients is decreasing in the advanced, metastatic stage from 99% to 26%. Therefore an optimization of the therapy of advanced breast cancer is urgently needed.
To increase the echogenicity of the blood in the ultrasound, microbubbles were developed working as stable, biocompatible contrast agent in ultrasound. Such a clinically approved ultrasound contrast agent is SonoVue® (Bracco International B.V., Amsterdam). SonoVue® is approved by the European Medicines Agency (EMA) (approval number EU/1/01/177/002) for the visualization of focal vascularization lesions of the liver and breast within Doppler sonography and is applied in breast cancer patients primarily for the purpose of diagnosis as well as to evaluate the response to the neoadjuvant used chemotherapy.
Animal studies using the contrast enhanced ultrasound have shown that the administration of this contrast agent increases the penetration and accumulation of drugs in the tumor as well as the permeability of the blood-brain barrier resulting in a precise and effective drug distribution. In the tumor animal model it could be shown that a combined treatment with chemotherapy and contrast enhanced ultrasound results in a decreased tumor growth and a prolonged survival. Patients with inoperable pancreatic cancer showed a reduced tumor growth and better tolerability of chemotherapy when administrating the contrast enhanced diagnostic ultrasound during palliative chemotherapy. This could be due to the better tumor response, but also due to the more targeted chemotherapy distribution.
The purpose of this study is to examine whether the use of the contrast enhanced diagnostic ultrasound during neoadjuvant chemotherapy results in an increased tumor regression in comparison to native ultrasound. It is an Investigator Initiated Trial and is funded by internal means.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Parellel Assignment
| Arm | Type | Receives |
|---|---|---|
| A | Active comparator | Drug: SonoVueApplication and measurement of tumor size using contrast agent-enhanced diagnostic and therapy supporting (with SonoVue®) ultrasound |
| B | No intervention | –Application and measurement of tumor size using contrast agent-enhanced diagnostic ultrasound |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- written informed consent
- age > 18 yrs
- histologically confirmed primary breast cancer including all intrinsic subtypes
- treatment with neoadjuvant chemotherapy
- persons who are legally competent and mentally able to follow the instructions of the study team
Key exclusion criteria (10 listed)
- hypersensitivity / allergy to sulfur hexafluoride, Macrogol 4000, distearoylphosphatidylcholine, dipalmitoylphosphatidylglycerol-sodium, palmitic acid
- right-left shunt,
- severe pulmonary hypertension (pulmonary arterial pressure > 90 mmHg)
- uncontrolled systemic hypertension
- acute respiratory distress syndrome
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 |
|---|---|---|
| SonoVueAs part of the study therapy supportive ultrasound will be performed with iv Infusion of the chemotherapeutic agent. | Drug | A |
Primary outcome
Tumor size reduction (1)
Time frame: 18 / 24 weeks
pCR (pathohistological complete remission)
Tumor size reduction (2)
Time frame: 18 / 24 weeks
cCR (clinical complete remission)
Tumor size reduction (3)
Time frame: 18 / 24 weeks
measured by ultrasound (% reduction in therapy)
5 secondary outcomes
proliferation rate of the tumor cells
Time frame: 18 / 24 weeks
narrowing the invasion front of the tumors
Time frame: 18 / 24 weeks
macrophage density in the tumor
Time frame: 18 / 24 weeks
vascularization of the tumor
Time frame: 18 / 24 weeks
tolerability of chemotherapy
Time frame: 18 / 24 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Dec 2017.
- Individual participant dataSharing planned: Undecided. The study results will be published in at least one scientific article.
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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.
Elmar Stickeler, niv.-Prof. Dr. med. principal investigator
Department of Gynecology and Obstetrics
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 SonoVue in people with Early Primary Breast Cancer, run by RWTH Aachen University at 1 site 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 5 inclusion and 10 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 28 Dec 2017. 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 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 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 Elmar Stickeler, Univ.-Prof. Dr. med. (+49 241 80 88400, estickeler@ukaachen.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tumor size reduction (1) (time frame: 18 / 24 weeks). The study lists 3 primary outcomes in all. 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 28 Dec 2017.