Breast CancerNCT02521363
Implantable Microdevice for In Vivo Drug Sensitivity Testing in Patients With Early Stage, HER2-Positive or Triple Negative Breast Cancer
A study testing KIBUR MICRODEVICE and anthracycline and taxane based chemotherapy in people with Breast Cancer, run by Memorial Sloan Kettering Cancer Center at 6 sites in United States.
Trial summary
The purpose of this study is to test the safety and feasibility of placing and removing a small device that contains anti-cancer drugs in a breast tumor of patients who plan on having breast surgery without treatment prior or patients who plan on receiving standard preoperative chemotherapy prior to their breast… Read more about this study
- Who is it for?
- Ages 19 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- KIBUR MICRODEVICE and anthracycline and taxane based chemotherapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 6 sitesUnited States
- Study dates
- 24 Jul 2015to 1 Aug 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 19 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with histologically confirmed invasive breast cancer that is: Triple negative (ER<10%, PR<10%, and HER2 0/1+ or 2+/FISH not amplified)
- Tumor size 2cm or greater; N any; M0
- Tumor size 1cm or greater; N any; M0 (Cohort 1)
- Tumor size 2cm or greater; N any; M0 (Cohort 2)
- Candidate for curative breast cancer surgery (Cohort 1 or 2)
- Candidate for neoadjuvant chemotherapy with a standard of care, anthracycline-based regimen (Cohort 2 preferred over Cohort 1)
Show all 10Show fewer
- Age >18 years of age
- ECOG performance status of ≤2
- Serum or urine pregnancy test negative within 2 weeks for women of childbearing potential.
- Willing and able to provide informed consent
Who cannot join
- Prior treatment including surgery, chemotherapy or radiation therapy for the current primary breast cancer.
- Severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational device administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the patient inappropriate for entry into this
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Memorial Sloan-Kettering at Basking Ridge
Basking Ridge, New Jersey, 07920
Memorial Sloan-Kettering Cancer Center at Commack
Commack, New York, 11725
Memorial Sloan Kettering Westchester
Harrison, New York, 10604
Memorial Sloan Kettering Monmouth
Middletown, New Jersey, 07748
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
Memorial Sloan-Kettering Cancer Center at Mercy Medical Center
Rockville Centre, New York, 11570
About this study
Official title: Pilot Trial of an Implantable Microdevice for In Vivo Drug Sensitivity Testing in Patients With Early Stage, HER2-Positive or Triple Negative Breast Cancer
The purpose of this study is to test the safety and feasibility of placing and removing a small device that contains anti-cancer drugs in a breast tumor of patients who plan on having breast surgery without treatment prior or patients who plan on receiving standard preoperative chemotherapy prior to their breast surgery. This device may be able to predict what types of treatment work best against an individual's breast cancer. With this device, the investigators hope to be able to personalize treatment choices based on an individual's type of breast cancer.
- Conditions
- Breast Cancer
- Being tested
- KIBUR MICRODEVICE, anthracycline and taxane based chemotherapy
- Keywords
- Implantable Microdevice, In Vivo Drug Sensitivity Testing, HER2-Positive, Triple Negative, 15-127
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KIBUR MICRODEVICEDevice
This device contains 16 reservoirs, each with a unique single agent or drug combination in microdose amounts of less than one millionth of a systemic patient dose. The device is implanted directly into the tumor during a biopsy procedure, and remains in situ for ~24 hours.
anthracycline and taxane based chemotherapyDrug
Conventional, standard of care neoadjuvant chemotherapy delivered irrespective of device readout
| Study group | Role | What they receive |
|---|---|---|
| Upfront Breast Surgery | Experimental | Patients will have the microdevice implanted prior to breast surgery, in the absence of neoadjuvant chemotherapy Receives: Device: KIBUR MICRODEVICE |
| Neoadjuvant Therapy | Experimental | Patients will have the device placed and retrieved on a core biopsy the following day, then receive neoadjuvant chemotherapy prior to definitive breast surgery. Receives: Device: KIBUR MICRODEVICE; Drug: anthracycline and taxane based chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Implantable Devices
If we are able to collect data from at least 6 out of the 12 patients, we will deem this study feasible to conduct in a larger cohort of patients.
Measured: Up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2015 (estimated)
- Study start24 Jul 2015
- Primary completion1 Aug 2024
- Study completion1 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering Cancer CenterThe 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 N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tiffany Traina, MD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02521363
- Sponsor's protocol ID
- 15-127
- Status last verified
- Aug 2024
- First submitted
- 5 Aug 2015
- Last updated
- 22 Aug 2025
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Trial of an Implantable Microdevice for In Vivo Drug Sensitivity Testing in Patients With Early Stage, HER2-Positive or Triple Negative Breast Cancer
- ClinicalTrials.gov ID
- NCT02521363
- Acronym / sponsor ID
- 15-127
- Conditions
- Breast Cancer
- Keywords
- Implantable Microdevice, In Vivo Drug Sensitivity Testing, HER2-Positive, Triple Negative, 15-127
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Study start
- 24 Jul 2015 (actual)
- Primary completion
- 1 Aug 2024 (actual)
- Study completion
- 1 Aug 2024 (actual)
- First posted
- 13 Aug 2015 (estimated)
- Results
- Posted 22 Aug 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to test the safety and feasibility of placing and removing a small device that contains anti-cancer drugs in a breast tumor of patients who plan on having breast surgery without treatment prior or patients who plan on receiving standard preoperative chemotherapy prior to their breast surgery. This device may be able to predict what types of treatment work best against an individual's breast cancer. With this device, the investigators hope to be able to personalize treatment choices based on an individual's type of breast cancer.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Upfront Breast Surgery | Experimental | Device: KIBUR MICRODEVICEPatients will have the microdevice implanted prior to breast surgery, in the absence of neoadjuvant chemotherapy |
| Neoadjuvant Therapy | Experimental | Device: KIBUR MICRODEVICE, Drug: anthracycline and taxane based chemotherapyPatients will have the device placed and retrieved on a core biopsy the following day, then receive neoadjuvant chemotherapy prior to definitive breast surgery. |
Who may qualify
- Ages
- 19 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Patients with histologically confirmed invasive breast cancer that is: Triple negative (ER<10%, PR<10%, and HER2 0/1+ or 2+/FISH not amplified)
- Tumor size 2cm or greater; N any; M0
- Tumor size 1cm or greater; N any; M0 (Cohort 1)
- Tumor size 2cm or greater; N any; M0 (Cohort 2)
- Candidate for curative breast cancer surgery (Cohort 1 or 2)
Key exclusion criteria (2 listed)
- Prior treatment including surgery, chemotherapy or radiation therapy for the current primary breast cancer.
- Severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational device administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the patient inappropriate for entry into this
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 |
|---|---|---|
| KIBUR MICRODEVICEThis device contains 16 reservoirs, each with a unique single agent or drug combination in microdose amounts of less than one millionth of a systemic patient dose. The device is implanted directly into the tumor during a biopsy procedure, and remains in situ for ~24 hours. | Device | Neoadjuvant Therapy, Upfront Breast Surgery |
| anthracycline and taxane based chemotherapyConventional, standard of care neoadjuvant chemotherapy delivered irrespective of device readout | Drug | Neoadjuvant Therapy |
Primary outcome
Number of Participants With Implantable Devices
Time frame: Up to 1 year
If we are able to collect data from at least 6 out of the 12 patients, we will deem this study feasible to conduct in a larger cohort of patients.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Memorial Sloan Kettering Cancer CenterLink provided by the sponsor.
Related trials for Breast Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingPhase 2
Gene Signatures to Guide HR+MBC Therapy in a Diverse Cohort
Invasive Mammary Carcinoma, Metastatic Breast Cancer
Not yet recruitingObservational study
Comparison of Reliability, Time Cost, and Participant Comfort of Lymphedema Assessments in Upper Extremity
Lymphedema, Upper Extremity Lymphedema
RecruitingPhase 3
A Study of Camrelizumab Plus Chemotherapy in Combination With or Without Famitinib as Neoadjuvant Therapy in Participants With Triple Negative Breast Cancer (BCTOP-T-N01)
TNBC - Triple-Negative Breast Cancer
RecruitingPhase 3
Testing Whether Hormone Therapy With Ribociclib is as Effective as Chemotherapy Followed by Hormone Therapy With Ribociclib for the Treatment of High Anatomic Stage Breast Cancer With Low Recurrence Risk, The RxFINE-Low Trial
Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8
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.
Tiffany Traina, MD principal investigator
Memorial Sloan Kettering Cancer Center
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing KIBUR MICRODEVICE and anthracycline and taxane based chemotherapy in people with Breast Cancer, run by Memorial Sloan Kettering Cancer Center at 6 sites in United States.
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 2 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 22 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States. 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 22 Aug 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants With Implantable Devices (time frame: Up to 1 year). 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 22 Aug 2025.