Trial Outcomes & Findings for Implantable Microdevice for In Vivo Drug Sensitivity Testing in Patients With Early Stage, HER2-Positive or Triple Negative Breast Cancer (NCT NCT02521363)
NCT ID: NCT02521363
Last Updated: 2025-08-22
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
11 participants
Primary outcome timeframe
Up to 1 year
Results posted on
2025-08-22
Participant Flow
Participant milestones
| Measure |
Upfront Breast Surgery
Patients will have the microdevice implanted prior to breast surgery, in the absence of neoadjuvant chemotherapy
KIBUR MICRODEVICE: 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.
|
Neoadjuvant Therapy
Patients will have the device placed and retrieved on a core biopsy the following day, then receive neoadjuvant chemotherapy prior to definitive breast surgery.
KIBUR MICRODEVICE: 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 chemotherapy: Conventional, standard of care neoadjuvant chemotherapy delivered irrespective of device readout
|
|---|---|---|
|
Overall Study
STARTED
|
4
|
7
|
|
Overall Study
COMPLETED
|
3
|
5
|
|
Overall Study
NOT COMPLETED
|
1
|
2
|
Reasons for withdrawal
| Measure |
Upfront Breast Surgery
Patients will have the microdevice implanted prior to breast surgery, in the absence of neoadjuvant chemotherapy
KIBUR MICRODEVICE: 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.
|
Neoadjuvant Therapy
Patients will have the device placed and retrieved on a core biopsy the following day, then receive neoadjuvant chemotherapy prior to definitive breast surgery.
KIBUR MICRODEVICE: 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 chemotherapy: Conventional, standard of care neoadjuvant chemotherapy delivered irrespective of device readout
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
2
|
Baseline Characteristics
Implantable Microdevice for In Vivo Drug Sensitivity Testing in Patients With Early Stage, HER2-Positive or Triple Negative Breast Cancer
Baseline characteristics by cohort
| Measure |
Upfront Breast Surgery
n=4 Participants
Patients will have the microdevice implanted prior to breast surgery, in the absence of neoadjuvant chemotherapy
KIBUR MICRODEVICE: 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.
|
Neoadjuvant Therapy
n=7 Participants
Patients will have the device placed and retrieved on a core biopsy the following day, then receive neoadjuvant chemotherapy prior to definitive breast surgery.
KIBUR MICRODEVICE: 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 chemotherapy: Conventional, standard of care neoadjuvant chemotherapy delivered irrespective of device readout
|
Total
n=11 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
55.5 years
n=99 Participants
|
43.9 years
n=107 Participants
|
48 years
n=206 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
11 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
3 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
2 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
4 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
11 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Up to 1 yearIf 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.
Outcome measures
| Measure |
Upfront Breast Surgery
n=4 Participants
Patients will have the microdevice implanted prior to breast surgery, in the absence of neoadjuvant chemotherapy
KIBUR MICRODEVICE: 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.
|
Neoadjuvant Therapy
n=7 Participants
Patients will have the device placed and retrieved on a core biopsy the following day, then receive neoadjuvant chemotherapy prior to definitive breast surgery.
KIBUR MICRODEVICE: 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 chemotherapy: Conventional, standard of care neoadjuvant chemotherapy delivered irrespective of device readout
|
|---|---|---|
|
Number of Participants With Implantable Devices
Participants with implantable devices
|
3 Participants
|
5 Participants
|
|
Number of Participants With Implantable Devices
Not evaluable
|
1 Participants
|
2 Participants
|
Adverse Events
Upfront Breast Surgery
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Neoadjuvant Therapy
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Tiffany Traina, MD
Memorial Sloan Kettering Cancer Center
Phone: 646-888-4558
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place