Trial Outcomes & Findings for Pre-operative IRX-2 in Early Stage Breast Cancer (ESBC) (NCT NCT02950259)
NCT ID: NCT02950259
Last Updated: 2025-12-03
Results Overview
The safety of IRX-2 will be determined by any surgical delays associated with administration of the study regimen.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
16 participants
Primary outcome timeframe
Day 1 to Day 26
Results posted on
2025-12-03
Participant Flow
Participant milestones
| Measure |
IRX-2 Regimen -Early Stage Breast Cancer
Enrolled subjects with early stage breast cancer will receive a single dose of cyclophosphamide (300 mg/m2) by IV infusion on Day 1. Also starting on Day 1 and continuing until Day 21, subjects will take daily oral indomethacin (25 mg three times each day), daily oral omeprazole (one tablet) and daily oral multivitamin containing 15-30 mg of zinc. On any 10 consecutive day period between Days 4-17, patients will receive two 1 mL subcutaneous periareolar injections of IRX-2.
Cyclophosphamide: One dose of cyclophosphamide 300 mg/m2 IV infusion
Indomethacin: Indomethacin 25 mg three times a day for 21 days
Omeprazole: One tablet of omeprazole daily for 21 days
Multivitamin: Daily multivitamin containing 15-30 mg of zinc for 21 days.
|
IRX-2 Regimen -Triple Negative Breast Cancer
Enrolled subjects with triple negative breast cancer will receive a single dose of cyclophosphamide (300 mg/m2) by IV infusion on Day 1. Also starting on Day 1 and continuing until Day 21, subjects will take daily oral indomethacin (25 mg three times each day), daily oral omeprazole (one tablet) and daily oral multivitamin containing 15-30 mg of zinc. On any 10 consecutive day period between Days 4-17, patients will receive two 1 mL subcutaneous periareolar injections of IRX-2.
Cyclophosphamide: One dose of cyclophosphamide 300 mg/m2 IV infusion
Indomethacin: Indomethacin 25 mg three times a day for 21 days
Omeprazole: One tablet of omeprazole daily for 21 days
Multivitamin: Daily multivitamin containing 15-30 mg of zinc for 21 days.
|
|---|---|---|
|
Overall Study
STARTED
|
16
|
0
|
|
Overall Study
COMPLETED
|
16
|
0
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Pre-operative IRX-2 in Early Stage Breast Cancer (ESBC)
Baseline characteristics by cohort
| Measure |
IRX-2 Regimen -Early Stage Breast Cancer
n=16 Participants
Enrolled subjects with early stage breast cancer will receive a single dose of cyclophosphamide (300 mg/m2) by IV infusion on Day 1. Also starting on Day 1 and continuing until Day 21, subjects will take daily oral indomethacin (25 mg three times each day), daily oral omeprazole (one tablet) and daily oral multivitamin containing 15-30 mg of zinc. On any 10 consecutive day period between Days 4-17, patients will receive two 1 mL subcutaneous periareolar injections of IRX-2.
Cyclophosphamide: One dose of cyclophosphamide 300 mg/m2 IV infusion
Indomethacin: Indomethacin 25 mg three times a day for 21 days
Omeprazole: One tablet of omeprazole daily for 21 days
Multivitamin: Daily multivitamin containing 15-30 mg of zinc for 21 days.
|
IRX-2 Regimen -Triple Negative Breast Cancer
Enrolled subjects with triple negative breast cancer will receive a single dose of cyclophosphamide (300 mg/m2) by IV infusion on Day 1. Also starting on Day 1 and continuing until Day 21, subjects will take daily oral indomethacin (25 mg three times each day), daily oral omeprazole (one tablet) and daily oral multivitamin containing 15-30 mg of zinc. On any 10 consecutive day period between Days 4-17, patients will receive two 1 mL subcutaneous periareolar injections of IRX-2.
Cyclophosphamide: One dose of cyclophosphamide 300 mg/m2 IV infusion
Indomethacin: Indomethacin 25 mg three times a day for 21 days
Omeprazole: One tablet of omeprazole daily for 21 days
Multivitamin: Daily multivitamin containing 15-30 mg of zinc for 21 days.
|
Total
n=16 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=9 Participants
|
—
|
0 Participants
n=9 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
12 Participants
n=9 Participants
|
—
|
12 Participants
n=9 Participants
|
|
Age, Categorical
>=65 years
|
4 Participants
n=9 Participants
|
—
|
4 Participants
n=9 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=9 Participants
|
—
|
16 Participants
n=9 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=9 Participants
|
—
|
0 Participants
n=9 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=9 Participants
|
—
|
1 Participants
n=9 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
14 Participants
n=9 Participants
|
—
|
14 Participants
n=9 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=9 Participants
|
—
|
1 Participants
n=9 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=9 Participants
|
—
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=9 Participants
|
—
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=9 Participants
|
—
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=9 Participants
|
—
|
1 Participants
n=9 Participants
|
|
Race (NIH/OMB)
White
|
15 Participants
n=9 Participants
|
—
|
15 Participants
n=9 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=9 Participants
|
—
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=9 Participants
|
—
|
0 Participants
n=9 Participants
|
|
Region of Enrollment
United States
|
16 Participants
n=9 Participants
|
—
|
16 Participants
n=9 Participants
|
|
Menstrual Status
Premenopausal
|
6 Participants
n=9 Participants
|
—
|
6 Participants
n=9 Participants
|
|
Menstrual Status
Post-menopausal
|
10 Participants
n=9 Participants
|
—
|
10 Participants
n=9 Participants
|
|
Family History of Breast/Ovarian Cancer
Yes
|
5 Participants
n=9 Participants
|
—
|
5 Participants
n=9 Participants
|
|
Family History of Breast/Ovarian Cancer
No
|
10 Participants
n=9 Participants
|
—
|
10 Participants
n=9 Participants
|
|
Family History of Breast/Ovarian Cancer
Unknown/Not Reported
|
1 Participants
n=9 Participants
|
—
|
1 Participants
n=9 Participants
|
|
Known BRCA 1/2 Mutation
Yes
|
3 Participants
n=9 Participants
|
—
|
3 Participants
n=9 Participants
|
|
Known BRCA 1/2 Mutation
No
|
1 Participants
n=9 Participants
|
—
|
1 Participants
n=9 Participants
|
|
Known BRCA 1/2 Mutation
Unknown
|
12 Participants
n=9 Participants
|
—
|
12 Participants
n=9 Participants
|
PRIMARY outcome
Timeframe: Day 1 to Day 26Population: No patients were enrolled into Arm B due to poor accrual and opted against Arm B in favor of the NeoIRX trial.
The safety of IRX-2 will be determined by any surgical delays associated with administration of the study regimen.
Outcome measures
| Measure |
IRX-2 Regimen -Early Stage Breast Cancer
n=16 Participants
Enrolled subjects with early stage breast cancer will receive a single dose of cyclophosphamide (300 mg/m2) by IV infusion on Day 1. Also starting on Day 1 and continuing until Day 21, subjects will take daily oral indomethacin (25 mg three times each day), daily oral omeprazole (one tablet) and daily oral multivitamin containing 15-30 mg of zinc. On any 10 consecutive day period between Days 4-17, patients will receive two 1 mL subcutaneous periareolar injections of IRX-2.
Cyclophosphamide: One dose of cyclophosphamide 300 mg/m2 IV infusion
Indomethacin: Indomethacin 25 mg three times a day for 21 days
Omeprazole: One tablet of omeprazole daily for 21 days
Multivitamin: Daily multivitamin containing 15-30 mg of zinc for 21 days.
|
IRX-2 Regimen -Triple Negative Breast Cancer
Enrolled subjects with triple negative breast cancer will receive a single dose of cyclophosphamide (300 mg/m2) by IV infusion on Day 1. Also starting on Day 1 and continuing until Day 21, subjects will take daily oral indomethacin (25 mg three times each day), daily oral omeprazole (one tablet) and daily oral multivitamin containing 15-30 mg of zinc. On any 10 consecutive day period between Days 4-17, patients will receive two 1 mL subcutaneous periareolar injections of IRX-2.
Cyclophosphamide: One dose of cyclophosphamide 300 mg/m2 IV infusion
Indomethacin: Indomethacin 25 mg three times a day for 21 days
Omeprazole: One tablet of omeprazole daily for 21 days
Multivitamin: Daily multivitamin containing 15-30 mg of zinc for 21 days.
|
|---|---|---|
|
Establish the Safety of the IRX-2 Regimen When Administered Pre-operatively in Early Stage Breast Cancer (ESBC) Patients
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: At time of pre-surgical biopsy and time of tumor specimen resection at day 26Population: Due to poor patient accrual we opted against enrolling into Cohort B in favor of the neoIRX trial.
Change in tumor infiltrating lymphocyte (TIL) score as measured by hematoxylin and eosin tumor infiltrating lymphocytes (H\&E TIL) count according to Salgado criteria from pre-surgical biopsy to resected tumor specimen
Outcome measures
| Measure |
IRX-2 Regimen -Early Stage Breast Cancer
n=16 Participants
Enrolled subjects with early stage breast cancer will receive a single dose of cyclophosphamide (300 mg/m2) by IV infusion on Day 1. Also starting on Day 1 and continuing until Day 21, subjects will take daily oral indomethacin (25 mg three times each day), daily oral omeprazole (one tablet) and daily oral multivitamin containing 15-30 mg of zinc. On any 10 consecutive day period between Days 4-17, patients will receive two 1 mL subcutaneous periareolar injections of IRX-2.
Cyclophosphamide: One dose of cyclophosphamide 300 mg/m2 IV infusion
Indomethacin: Indomethacin 25 mg three times a day for 21 days
Omeprazole: One tablet of omeprazole daily for 21 days
Multivitamin: Daily multivitamin containing 15-30 mg of zinc for 21 days.
|
IRX-2 Regimen -Triple Negative Breast Cancer
Enrolled subjects with triple negative breast cancer will receive a single dose of cyclophosphamide (300 mg/m2) by IV infusion on Day 1. Also starting on Day 1 and continuing until Day 21, subjects will take daily oral indomethacin (25 mg three times each day), daily oral omeprazole (one tablet) and daily oral multivitamin containing 15-30 mg of zinc. On any 10 consecutive day period between Days 4-17, patients will receive two 1 mL subcutaneous periareolar injections of IRX-2.
Cyclophosphamide: One dose of cyclophosphamide 300 mg/m2 IV infusion
Indomethacin: Indomethacin 25 mg three times a day for 21 days
Omeprazole: One tablet of omeprazole daily for 21 days
Multivitamin: Daily multivitamin containing 15-30 mg of zinc for 21 days.
|
|---|---|---|
|
Tumor Infiltrating Lymphocytes
|
0.4 percentage of stromal area
Interval -0.2 to 12.8
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Day 1 to Day 26Population: Due to poor accrual we opted against enrolling in Cohort B in favor of the neoIRX trial.
Fold change of peripheral lymphocytes including activated T-cells, T-regulatory cells, natural killer (NK) cells, and myeloid cells
Outcome measures
| Measure |
IRX-2 Regimen -Early Stage Breast Cancer
n=16 Participants
Enrolled subjects with early stage breast cancer will receive a single dose of cyclophosphamide (300 mg/m2) by IV infusion on Day 1. Also starting on Day 1 and continuing until Day 21, subjects will take daily oral indomethacin (25 mg three times each day), daily oral omeprazole (one tablet) and daily oral multivitamin containing 15-30 mg of zinc. On any 10 consecutive day period between Days 4-17, patients will receive two 1 mL subcutaneous periareolar injections of IRX-2.
Cyclophosphamide: One dose of cyclophosphamide 300 mg/m2 IV infusion
Indomethacin: Indomethacin 25 mg three times a day for 21 days
Omeprazole: One tablet of omeprazole daily for 21 days
Multivitamin: Daily multivitamin containing 15-30 mg of zinc for 21 days.
|
IRX-2 Regimen -Triple Negative Breast Cancer
Enrolled subjects with triple negative breast cancer will receive a single dose of cyclophosphamide (300 mg/m2) by IV infusion on Day 1. Also starting on Day 1 and continuing until Day 21, subjects will take daily oral indomethacin (25 mg three times each day), daily oral omeprazole (one tablet) and daily oral multivitamin containing 15-30 mg of zinc. On any 10 consecutive day period between Days 4-17, patients will receive two 1 mL subcutaneous periareolar injections of IRX-2.
Cyclophosphamide: One dose of cyclophosphamide 300 mg/m2 IV infusion
Indomethacin: Indomethacin 25 mg three times a day for 21 days
Omeprazole: One tablet of omeprazole daily for 21 days
Multivitamin: Daily multivitamin containing 15-30 mg of zinc for 21 days.
|
|---|---|---|
|
Characterization of Peripheral Lymphocytes
Stroma, Any PD-L1: Helper T-Cell
|
2.05 fold change
Interval 1.14 to 3.7
|
—
|
|
Characterization of Peripheral Lymphocytes
Stroma, Any PD-L1: Cytotoxic T-Cell
|
2.55 fold change
Interval 1.8 to 3.61
|
—
|
|
Characterization of Peripheral Lymphocytes
Stroma, Any PD-L1: Regulatory T-Cell
|
0.91 fold change
Interval 0.6 to 1.39
|
—
|
|
Characterization of Peripheral Lymphocytes
Stroma, Any PD-L1: Macrophage
|
0.86 fold change
Interval 0.54 to 1.38
|
—
|
|
Characterization of Peripheral Lymphocytes
Stroma, PD-L1-positive: T-Cell (any type)
|
3.54 fold change
Interval 1.86 to 6.76
|
—
|
|
Characterization of Peripheral Lymphocytes
Stroma, PD-L1-positive: Helper T-Cell
|
3.58 fold change
Interval 1.76 to 7.29
|
—
|
|
Characterization of Peripheral Lymphocytes
Stroma, PD-L1-positive: Cytotoxic T-Cell
|
2.98 fold change
Interval 1.74 to 5.08
|
—
|
|
Characterization of Peripheral Lymphocytes
Stroma, PD-L1-positive: Regulatory T-cell
|
1.38 fold change
Interval 0.78 to 2.46
|
—
|
|
Characterization of Peripheral Lymphocytes
Stroma, PD-L1-positive: Macrophage
|
1.63 fold change
Interval 0.84 to 3.13
|
—
|
|
Characterization of Peripheral Lymphocytes
Tumor, Any PD-L1: T-Cell (any type)
|
1.07 fold change
Interval 0.65 to 1.77
|
—
|
|
Characterization of Peripheral Lymphocytes
Tumor, Any PD-L1: Helper T-Cell
|
0.77 fold change
Interval 0.49 to 1.22
|
—
|
|
Characterization of Peripheral Lymphocytes
Tumor, Any PD-L1: Cytotoxic T-Cell
|
1.36 fold change
Interval 0.91 to 2.05
|
—
|
|
Characterization of Peripheral Lymphocytes
Tumor, Any PD-L1: Regulatory T-Cell
|
0.79 fold change
Interval 0.49 to 1.29
|
—
|
|
Characterization of Peripheral Lymphocytes
Tumor, Any PD-L1: Macrophage
|
0.65 fold change
Interval 0.38 to 1.09
|
—
|
|
Characterization of Peripheral Lymphocytes
Tumor, PD-L1-positive: T-Cell (any type)
|
1.50 fold change
Interval 0.86 to 2.63
|
—
|
|
Characterization of Peripheral Lymphocytes
Tumor, PD-L1-positive: Helper T-cell
|
1.07 fold change
Interval 0.56 to 2.04
|
—
|
|
Characterization of Peripheral Lymphocytes
Tumor, PD-L1-positive: Cytotoxic T-Cell
|
1.68 fold change
Interval 1.06 to 2.64
|
—
|
|
Characterization of Peripheral Lymphocytes
Tumor, PD-L1-positive: Regulatory T-Cell
|
0.64 fold change
Interval 0.32 to 1.29
|
—
|
|
Characterization of Peripheral Lymphocytes
Tumor, PD-L1-positive: Macrophage
|
0.87 fold change
Interval 0.51 to 1.49
|
—
|
|
Characterization of Peripheral Lymphocytes
Stoma and tumor, PD-L1-positive: PD-L1+ IC^3
|
3.14 fold change
Interval 1.68 to 5.87
|
—
|
|
Characterization of Peripheral Lymphocytes
Stroma, Any PD-L1: T-Cell (any type)
|
2.01 fold change
Interval 1.32 to 3.08
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Day 1 to 26Population: Due to poor patient accrual we opted against enrolling into Cohort B in favor of the neoIRX trial.
Post-IRX mean density of T-regulatory cells, activated T-cells, myeloid lineages and dendritic cells post-IRX within stromal tissue compartments.
Outcome measures
| Measure |
IRX-2 Regimen -Early Stage Breast Cancer
n=16 Participants
Enrolled subjects with early stage breast cancer will receive a single dose of cyclophosphamide (300 mg/m2) by IV infusion on Day 1. Also starting on Day 1 and continuing until Day 21, subjects will take daily oral indomethacin (25 mg three times each day), daily oral omeprazole (one tablet) and daily oral multivitamin containing 15-30 mg of zinc. On any 10 consecutive day period between Days 4-17, patients will receive two 1 mL subcutaneous periareolar injections of IRX-2.
Cyclophosphamide: One dose of cyclophosphamide 300 mg/m2 IV infusion
Indomethacin: Indomethacin 25 mg three times a day for 21 days
Omeprazole: One tablet of omeprazole daily for 21 days
Multivitamin: Daily multivitamin containing 15-30 mg of zinc for 21 days.
|
IRX-2 Regimen -Triple Negative Breast Cancer
Enrolled subjects with triple negative breast cancer will receive a single dose of cyclophosphamide (300 mg/m2) by IV infusion on Day 1. Also starting on Day 1 and continuing until Day 21, subjects will take daily oral indomethacin (25 mg three times each day), daily oral omeprazole (one tablet) and daily oral multivitamin containing 15-30 mg of zinc. On any 10 consecutive day period between Days 4-17, patients will receive two 1 mL subcutaneous periareolar injections of IRX-2.
Cyclophosphamide: One dose of cyclophosphamide 300 mg/m2 IV infusion
Indomethacin: Indomethacin 25 mg three times a day for 21 days
Omeprazole: One tablet of omeprazole daily for 21 days
Multivitamin: Daily multivitamin containing 15-30 mg of zinc for 21 days.
|
|---|---|---|
|
TIL Phenotype
Any PD-L1: T-cell (any type)
|
1.27 count/pixel
Standard Deviation 0.15
|
—
|
|
TIL Phenotype
Any PD-L1: Helper T-cell
|
0.79 count/pixel
Standard Deviation .59
|
—
|
|
TIL Phenotype
Any PD-L1: Cytotoxic T-cell
|
0.42 count/pixel
Standard Deviation 0.30
|
—
|
|
TIL Phenotype
Any PD-L1: Regulatory T-cell
|
0.07 count/pixel
Standard Deviation 0.06
|
—
|
|
TIL Phenotype
Any PD-L1: Macrophage
|
0.19 count/pixel
Standard Deviation 0.12
|
—
|
|
TIL Phenotype
PD-L1-positive: T-cell (any type)
|
0.7 count/pixel
Standard Deviation 0.59
|
—
|
|
TIL Phenotype
PD-L1-positive: Helper T-Cell
|
0.47 count/pixel
Standard Deviation 0.46
|
—
|
|
TIL Phenotype
PD-L1-positive: Cytotoxic T-Cell
|
0.19 count/pixel
Standard Deviation 0.21
|
—
|
|
TIL Phenotype
PD-L1-positive: Macrophage
|
0.14 count/pixel
Standard Deviation 0.11
|
—
|
|
TIL Phenotype
PD-L1-positive: Regulatory T-Cell
|
0.05 count/pixel
Standard Deviation 0.05
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Day 1-26Population: Due to poor patient accrual we opted against enrolling into Cohort B in favor of the neoIRX trial.
Change in T-cell clonal responses by T-cell receptor DNA deep sequencing
Outcome measures
| Measure |
IRX-2 Regimen -Early Stage Breast Cancer
n=16 Participants
Enrolled subjects with early stage breast cancer will receive a single dose of cyclophosphamide (300 mg/m2) by IV infusion on Day 1. Also starting on Day 1 and continuing until Day 21, subjects will take daily oral indomethacin (25 mg three times each day), daily oral omeprazole (one tablet) and daily oral multivitamin containing 15-30 mg of zinc. On any 10 consecutive day period between Days 4-17, patients will receive two 1 mL subcutaneous periareolar injections of IRX-2.
Cyclophosphamide: One dose of cyclophosphamide 300 mg/m2 IV infusion
Indomethacin: Indomethacin 25 mg three times a day for 21 days
Omeprazole: One tablet of omeprazole daily for 21 days
Multivitamin: Daily multivitamin containing 15-30 mg of zinc for 21 days.
|
IRX-2 Regimen -Triple Negative Breast Cancer
Enrolled subjects with triple negative breast cancer will receive a single dose of cyclophosphamide (300 mg/m2) by IV infusion on Day 1. Also starting on Day 1 and continuing until Day 21, subjects will take daily oral indomethacin (25 mg three times each day), daily oral omeprazole (one tablet) and daily oral multivitamin containing 15-30 mg of zinc. On any 10 consecutive day period between Days 4-17, patients will receive two 1 mL subcutaneous periareolar injections of IRX-2.
Cyclophosphamide: One dose of cyclophosphamide 300 mg/m2 IV infusion
Indomethacin: Indomethacin 25 mg three times a day for 21 days
Omeprazole: One tablet of omeprazole daily for 21 days
Multivitamin: Daily multivitamin containing 15-30 mg of zinc for 21 days.
|
|---|---|---|
|
Intratumoral T-cell Clonality Response
Patient 1
|
0.7 fold change
|
—
|
|
Intratumoral T-cell Clonality Response
Patient 2
|
-0.2 fold change
|
—
|
|
Intratumoral T-cell Clonality Response
Patient 3
|
-0.3 fold change
|
—
|
|
Intratumoral T-cell Clonality Response
Patient 4
|
0.00 fold change
|
—
|
|
Intratumoral T-cell Clonality Response
Patient 5
|
0.2 fold change
|
—
|
|
Intratumoral T-cell Clonality Response
Patient 6
|
0.0 fold change
|
—
|
|
Intratumoral T-cell Clonality Response
Patient 7
|
0.1 fold change
|
—
|
|
Intratumoral T-cell Clonality Response
Patient 8
|
0.2 fold change
|
—
|
|
Intratumoral T-cell Clonality Response
Patient 9
|
-0.3 fold change
|
—
|
|
Intratumoral T-cell Clonality Response
Patient 10
|
0.2 fold change
|
—
|
|
Intratumoral T-cell Clonality Response
Patient 11
|
0.1 fold change
|
—
|
|
Intratumoral T-cell Clonality Response
Patient 12
|
-0.1 fold change
|
—
|
|
Intratumoral T-cell Clonality Response
Patient 14
|
NA fold change
Patient did not have available paired lymph node specimen available for analyzation.
|
—
|
|
Intratumoral T-cell Clonality Response
Patient 16
|
1.5 fold change
|
—
|
|
Intratumoral T-cell Clonality Response
Patient 13
|
-0.1 fold change
|
—
|
|
Intratumoral T-cell Clonality Response
Patient 15
|
-0.2 fold change
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Day 1-26Population: Due to poor patient accrual we opted against enrolling into Cohort B in favor of the neoIRX trial.
The Nanostring PanCancer Immune panel was used to estimate increase in PD-L1 mRNA expression among tumor-bearing FFPE specimens.
Outcome measures
| Measure |
IRX-2 Regimen -Early Stage Breast Cancer
n=16 Participants
Enrolled subjects with early stage breast cancer will receive a single dose of cyclophosphamide (300 mg/m2) by IV infusion on Day 1. Also starting on Day 1 and continuing until Day 21, subjects will take daily oral indomethacin (25 mg three times each day), daily oral omeprazole (one tablet) and daily oral multivitamin containing 15-30 mg of zinc. On any 10 consecutive day period between Days 4-17, patients will receive two 1 mL subcutaneous periareolar injections of IRX-2.
Cyclophosphamide: One dose of cyclophosphamide 300 mg/m2 IV infusion
Indomethacin: Indomethacin 25 mg three times a day for 21 days
Omeprazole: One tablet of omeprazole daily for 21 days
Multivitamin: Daily multivitamin containing 15-30 mg of zinc for 21 days.
|
IRX-2 Regimen -Triple Negative Breast Cancer
Enrolled subjects with triple negative breast cancer will receive a single dose of cyclophosphamide (300 mg/m2) by IV infusion on Day 1. Also starting on Day 1 and continuing until Day 21, subjects will take daily oral indomethacin (25 mg three times each day), daily oral omeprazole (one tablet) and daily oral multivitamin containing 15-30 mg of zinc. On any 10 consecutive day period between Days 4-17, patients will receive two 1 mL subcutaneous periareolar injections of IRX-2.
Cyclophosphamide: One dose of cyclophosphamide 300 mg/m2 IV infusion
Indomethacin: Indomethacin 25 mg three times a day for 21 days
Omeprazole: One tablet of omeprazole daily for 21 days
Multivitamin: Daily multivitamin containing 15-30 mg of zinc for 21 days.
|
|---|---|---|
|
Intratumoral Immune Response
Patient 1
|
.9 fold change
|
—
|
|
Intratumoral Immune Response
Patient 2
|
.6 fold change
|
—
|
|
Intratumoral Immune Response
Patient 3
|
0 fold change
|
—
|
|
Intratumoral Immune Response
Patient 4
|
.7 fold change
|
—
|
|
Intratumoral Immune Response
Patient 5
|
0 fold change
|
—
|
|
Intratumoral Immune Response
Patient 6
|
0 fold change
|
—
|
|
Intratumoral Immune Response
Patient 7
|
.5 fold change
|
—
|
|
Intratumoral Immune Response
Patient 8
|
-.5 fold change
|
—
|
|
Intratumoral Immune Response
Patient 9
|
.5 fold change
|
—
|
|
Intratumoral Immune Response
Patient 10
|
1.5 fold change
|
—
|
|
Intratumoral Immune Response
Patient 11
|
1.8 fold change
|
—
|
|
Intratumoral Immune Response
Patient 12
|
0 fold change
|
—
|
|
Intratumoral Immune Response
Patient 13
|
0 fold change
|
—
|
|
Intratumoral Immune Response
Patient 14
|
0 fold change
|
—
|
|
Intratumoral Immune Response
Patient 15
|
1.6 fold change
|
—
|
|
Intratumoral Immune Response
Patient 16
|
.7 fold change
|
—
|
Adverse Events
IRX-2 Regimen -Early Stage Breast Cancer
Serious events: 0 serious events
Other events: 16 other events
Deaths: 0 deaths
IRX-2 Regimen -Triple Negative Breast Cancer
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
IRX-2 Regimen -Early Stage Breast Cancer
n=16 participants at risk
Enrolled subjects with early stage breast cancer will receive a single dose of cyclophosphamide (300 mg/m2) by IV infusion on Day 1. Also starting on Day 1 and continuing until Day 21, subjects will take daily oral indomethacin (25 mg three times each day), daily oral omeprazole (one tablet) and daily oral multivitamin containing 15-30 mg of zinc. On any 10 consecutive day period between Days 4-17, patients will receive two 1 mL subcutaneous periareolar injections of IRX-2.
Cyclophosphamide: One dose of cyclophosphamide 300 mg/m2 IV infusion
Indomethacin: Indomethacin 25 mg three times a day for 21 days
Omeprazole: One tablet of omeprazole daily for 21 days
Multivitamin: Daily multivitamin containing 15-30 mg of zinc for 21 days.
|
IRX-2 Regimen -Triple Negative Breast Cancer
Enrolled subjects with triple negative breast cancer will receive a single dose of cyclophosphamide (300 mg/m2) by IV infusion on Day 1. Also starting on Day 1 and continuing until Day 21, subjects will take daily oral indomethacin (25 mg three times each day), daily oral omeprazole (one tablet) and daily oral multivitamin containing 15-30 mg of zinc. On any 10 consecutive day period between Days 4-17, patients will receive two 1 mL subcutaneous periareolar injections of IRX-2.
Cyclophosphamide: One dose of cyclophosphamide 300 mg/m2 IV infusion
Indomethacin: Indomethacin 25 mg three times a day for 21 days
Omeprazole: One tablet of omeprazole daily for 21 days
Multivitamin: Daily multivitamin containing 15-30 mg of zinc for 21 days.
|
|---|---|---|
|
Gastrointestinal disorders
Intermittent Nausea
|
6.2%
1/16 • Number of events 1 • 1 year, 3 months
Adverse event monitoring/recording happened at set time intervals as per study protocol
|
—
0/0 • 1 year, 3 months
Adverse event monitoring/recording happened at set time intervals as per study protocol
|
|
General disorders
Left Axillary Lymph Node Pain
|
6.2%
1/16 • Number of events 1 • 1 year, 3 months
Adverse event monitoring/recording happened at set time intervals as per study protocol
|
—
0/0 • 1 year, 3 months
Adverse event monitoring/recording happened at set time intervals as per study protocol
|
|
General disorders
Left Breast Pain
|
6.2%
1/16 • Number of events 1 • 1 year, 3 months
Adverse event monitoring/recording happened at set time intervals as per study protocol
|
—
0/0 • 1 year, 3 months
Adverse event monitoring/recording happened at set time intervals as per study protocol
|
|
General disorders
Mild Pain with Injections
|
6.2%
1/16 • Number of events 1 • 1 year, 3 months
Adverse event monitoring/recording happened at set time intervals as per study protocol
|
—
0/0 • 1 year, 3 months
Adverse event monitoring/recording happened at set time intervals as per study protocol
|
|
Gastrointestinal disorders
Nausea
|
56.2%
9/16 • Number of events 10 • 1 year, 3 months
Adverse event monitoring/recording happened at set time intervals as per study protocol
|
—
0/0 • 1 year, 3 months
Adverse event monitoring/recording happened at set time intervals as per study protocol
|
|
Respiratory, thoracic and mediastinal disorders
Pain with Injections
|
6.2%
1/16 • Number of events 1 • 1 year, 3 months
Adverse event monitoring/recording happened at set time intervals as per study protocol
|
—
0/0 • 1 year, 3 months
Adverse event monitoring/recording happened at set time intervals as per study protocol
|
|
Gastrointestinal disorders
Vomiting
|
12.5%
2/16 • Number of events 2 • 1 year, 3 months
Adverse event monitoring/recording happened at set time intervals as per study protocol
|
—
0/0 • 1 year, 3 months
Adverse event monitoring/recording happened at set time intervals as per study protocol
|
|
Skin and subcutaneous tissue disorders
Injection Site Reaction
|
50.0%
8/16 • Number of events 8 • 1 year, 3 months
Adverse event monitoring/recording happened at set time intervals as per study protocol
|
—
0/0 • 1 year, 3 months
Adverse event monitoring/recording happened at set time intervals as per study protocol
|
|
Blood and lymphatic system disorders
Anemia
|
6.2%
1/16 • Number of events 1 • 1 year, 3 months
Adverse event monitoring/recording happened at set time intervals as per study protocol
|
—
0/0 • 1 year, 3 months
Adverse event monitoring/recording happened at set time intervals as per study protocol
|
|
Gastrointestinal disorders
Abdominal Cramping
|
6.2%
1/16 • Number of events 1 • 1 year, 3 months
Adverse event monitoring/recording happened at set time intervals as per study protocol
|
—
0/0 • 1 year, 3 months
Adverse event monitoring/recording happened at set time intervals as per study protocol
|
|
Gastrointestinal disorders
Bloating
|
12.5%
2/16 • Number of events 2 • 1 year, 3 months
Adverse event monitoring/recording happened at set time intervals as per study protocol
|
—
0/0 • 1 year, 3 months
Adverse event monitoring/recording happened at set time intervals as per study protocol
|
|
Skin and subcutaneous tissue disorders
Bruising/Bruising at Injection Site
|
43.8%
7/16 • Number of events 7 • 1 year, 3 months
Adverse event monitoring/recording happened at set time intervals as per study protocol
|
—
0/0 • 1 year, 3 months
Adverse event monitoring/recording happened at set time intervals as per study protocol
|
|
Gastrointestinal disorders
Diarrhea
|
12.5%
2/16 • Number of events 2 • 1 year, 3 months
Adverse event monitoring/recording happened at set time intervals as per study protocol
|
—
0/0 • 1 year, 3 months
Adverse event monitoring/recording happened at set time intervals as per study protocol
|
|
General disorders
Fatigue
|
31.2%
5/16 • Number of events 5 • 1 year, 3 months
Adverse event monitoring/recording happened at set time intervals as per study protocol
|
—
0/0 • 1 year, 3 months
Adverse event monitoring/recording happened at set time intervals as per study protocol
|
|
Gastrointestinal disorders
Flatulence
|
12.5%
2/16 • Number of events 2 • 1 year, 3 months
Adverse event monitoring/recording happened at set time intervals as per study protocol
|
—
0/0 • 1 year, 3 months
Adverse event monitoring/recording happened at set time intervals as per study protocol
|
|
General disorders
Flu-like Symptoms
|
6.2%
1/16 • Number of events 1 • 1 year, 3 months
Adverse event monitoring/recording happened at set time intervals as per study protocol
|
—
0/0 • 1 year, 3 months
Adverse event monitoring/recording happened at set time intervals as per study protocol
|
|
General disorders
Headache
|
6.2%
1/16 • Number of events 1 • 1 year, 3 months
Adverse event monitoring/recording happened at set time intervals as per study protocol
|
—
0/0 • 1 year, 3 months
Adverse event monitoring/recording happened at set time intervals as per study protocol
|
Additional Information
Dr. David B. Page
Earle A. Chiles Research Institute, Providence Cancer Institute
Phone: 503-215-6588
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place