Breast Cancer
Conditions
Keywords
Implantable Microdevice, In Vivo Drug Sensitivity Testing, HER2-Positive, Triple Negative, 15-127
Brief 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 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.
Interventions
DEVICEKIBUR 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.
DRUGanthracycline and taxane based chemotherapy
Conventional, standard of care neoadjuvant chemotherapy delivered irrespective of device readout
Sponsors
Memorial Sloan Kettering Cancer Center
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
19 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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) * 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Implantable Devices | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 4 |
| 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 | 7 |
| Total | 11 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Withdrawal by Subject | 1 | 2 |
Baseline characteristics
| Characteristic | Upfront Breast Surgery | Total | Neoadjuvant Therapy |
|---|---|---|---|
| Age, Continuous | 55.5 years | 48 years | 43.9 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 2 Participants | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 3 Participants | 8 Participants | 5 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 3 Participants | 2 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 3 Participants | 2 Participants |
| Race (NIH/OMB) White | 2 Participants | 5 Participants | 3 Participants |
| Region of Enrollment United States | 4 Participants | 11 Participants | 7 Participants |
| Sex: Female, Male Female | 4 Participants | 11 Participants | 7 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 4 | 0 / 7 |
| other Total, other adverse events | 0 / 4 | 0 / 7 |
| serious Total, serious adverse events | 0 / 4 | 0 / 7 |
Outcome results
Primary
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.
Time frame: Up to 1 year
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Upfront Breast Surgery | Number of Participants With Implantable Devices | Participants with implantable devices | 3 Participants |
| Upfront Breast Surgery | Number of Participants With Implantable Devices | Not evaluable | 1 Participants |
| Neoadjuvant Therapy | Number of Participants With Implantable Devices | Participants with implantable devices | 5 Participants |
| Neoadjuvant Therapy | Number of Participants With Implantable Devices | Not evaluable | 2 Participants |