Trial Outcomes & Findings for Durvalumab With Trastuzumab and Pertuzumab in HER2-Enriched Breast Cancer (NCT NCT03820141)
NCT ID: NCT03820141
Last Updated: 2026-04-20
Results Overview
Determination of the pathologic response rate \[residual cancer burden (RCB)- 0, and RCB 1\] in the breast of durvalumab with trastuzumab and pertuzumab combination in patients with HER2-enriched and HER2-amplified breast cancer.
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
PHASE2
Target enrollment
51 participants
Primary outcome timeframe
18 weeks
Results posted on
2026-04-20
Participant Flow
51 patients were enrolled and 39 of the 51 patients started treatment. The first patient was consented on 6/30/2020 and the last patient was consented on 10/16/2023
Participant milestones
| Measure |
Durvalumab + Trastuzumab + Pertuzumab
Durvalumab, trastuzumab, and pertuzumab will be administered on Day 1 every 3 weeks for 6 cycles. Trastuzumab will be administered as 8 mg/kg intravenous (IV) loading dose, followed by 6 mg/kg IV. Pertuzumab will be administered as 840 mg IV loading dose, followed by 420 mg. Durvalumab will be administered at a fixed dose of 1120 mg IV.
Durvalumab: programmed cell death-ligand 1 inhibitor
Trastuzumab: anti-HER2 monoclonal antibody
Pertuzumab: anti-HER2 monoclonal antibody
|
|---|---|
|
Overall Study
STARTED
|
39
|
|
Overall Study
COMPLETED
|
37
|
|
Overall Study
NOT COMPLETED
|
2
|
Reasons for withdrawal
| Measure |
Durvalumab + Trastuzumab + Pertuzumab
Durvalumab, trastuzumab, and pertuzumab will be administered on Day 1 every 3 weeks for 6 cycles. Trastuzumab will be administered as 8 mg/kg intravenous (IV) loading dose, followed by 6 mg/kg IV. Pertuzumab will be administered as 840 mg IV loading dose, followed by 420 mg. Durvalumab will be administered at a fixed dose of 1120 mg IV.
Durvalumab: programmed cell death-ligand 1 inhibitor
Trastuzumab: anti-HER2 monoclonal antibody
Pertuzumab: anti-HER2 monoclonal antibody
|
|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
|
Overall Study
Death
|
1
|
Baseline Characteristics
Durvalumab With Trastuzumab and Pertuzumab in HER2-Enriched Breast Cancer
Baseline characteristics by cohort
| Measure |
Durvalumab + Trastuzumab + Pertuzumab
n=39 Participants
Durvalumab, trastuzumab, and pertuzumab will be administered on Day 1 every 3 weeks for 6 cycles. Trastuzumab will be administered as 8 mg/kg intravenous (IV) loading dose, followed by 6 mg/kg IV. Pertuzumab will be administered as 840 mg IV loading dose, followed by 420 mg. Durvalumab will be administered at a fixed dose of 1120 mg IV.
Durvalumab: programmed cell death-ligand 1 inhibitor
Trastuzumab: anti-HER2 monoclonal antibody
Pertuzumab: anti-HER2 monoclonal antibody
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=129 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
32 Participants
n=129 Participants
|
|
Age, Categorical
>=65 years
|
7 Participants
n=129 Participants
|
|
Age, Continuous
|
55 years
n=129 Participants
|
|
Sex: Female, Male
Female
|
39 Participants
n=129 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=129 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
16 Participants
n=129 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
23 Participants
n=129 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=129 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=129 Participants
|
|
Race (NIH/OMB)
Asian
|
4 Participants
n=129 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=129 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=129 Participants
|
|
Race (NIH/OMB)
White
|
31 Participants
n=129 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=129 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=129 Participants
|
|
Region of Enrollment
United States
|
39 participants
n=129 Participants
|
PRIMARY outcome
Timeframe: 18 weeksDetermination of the pathologic response rate \[residual cancer burden (RCB)- 0, and RCB 1\] in the breast of durvalumab with trastuzumab and pertuzumab combination in patients with HER2-enriched and HER2-amplified breast cancer.
Outcome measures
| Measure |
Durvalumab + Trastuzumab + Pertuzumab
n=37 Participants
Durvalumab, trastuzumab, and pertuzumab will be administered on Day 1 every 3 weeks for 6 cycles. Trastuzumab will be administered as 8 mg/kg intravenous (IV) loading dose, followed by 6 mg/kg IV. Pertuzumab will be administered as 840 mg IV loading dose, followed by 420 mg. Durvalumab will be administered at a fixed dose of 1120 mg IV.
Durvalumab: programmed cell death-ligand 1 inhibitor
Trastuzumab: anti-HER2 monoclonal antibody
Pertuzumab: anti-HER2 monoclonal antibody
|
|---|---|
|
Pathological Response Rate (RCB-0 and RCB-1) Rate in the Breast in Patients With HER2-enriched and HER2-amplified Breast Cancer
|
25 Participants
|
SECONDARY outcome
Timeframe: 18 weeksPopulation: The rows are in relation to a patient characteristic (TILs) where a patient can only have one or the other (Less than 5%/equal to or greater than 5%), the two rows added together will equal the 37 patients analyzed.
Determine pCR rate in the breast in patients whose tumors have \<5% and ≥5% tumor-infiltrating lymphocytes (TILs)
Outcome measures
| Measure |
Durvalumab + Trastuzumab + Pertuzumab
n=37 Participants
Durvalumab, trastuzumab, and pertuzumab will be administered on Day 1 every 3 weeks for 6 cycles. Trastuzumab will be administered as 8 mg/kg intravenous (IV) loading dose, followed by 6 mg/kg IV. Pertuzumab will be administered as 840 mg IV loading dose, followed by 420 mg. Durvalumab will be administered at a fixed dose of 1120 mg IV.
Durvalumab: programmed cell death-ligand 1 inhibitor
Trastuzumab: anti-HER2 monoclonal antibody
Pertuzumab: anti-HER2 monoclonal antibody
|
|---|---|
|
pCR Rate in the Breast in Patients Whose Tumors Have <5% and ≥5% TILs
pCR rate due to DTP alone in patients whose tumors have <5% TILS
|
66.7 Percentage of Patients
|
|
pCR Rate in the Breast in Patients Whose Tumors Have <5% and ≥5% TILs
pCR rate due to DTP alone pCR rate due to DTP alone in patients whose tumors have ≥5% TILs
|
45.2 Percentage of Patients
|
SECONDARY outcome
Timeframe: 18 weeksPopulation: The rows are in relation to a patient characteristic (PDL1) where a patient can only have one or the other (Positive/Negative), the two rows added together will equal the 37 patients analyzed.
Determine pCR rate in the breast in patients with programmed cell death-ligand 1 (PD-L1)-positive and PD-L1-negative tumors
Outcome measures
| Measure |
Durvalumab + Trastuzumab + Pertuzumab
n=37 Participants
Durvalumab, trastuzumab, and pertuzumab will be administered on Day 1 every 3 weeks for 6 cycles. Trastuzumab will be administered as 8 mg/kg intravenous (IV) loading dose, followed by 6 mg/kg IV. Pertuzumab will be administered as 840 mg IV loading dose, followed by 420 mg. Durvalumab will be administered at a fixed dose of 1120 mg IV.
Durvalumab: programmed cell death-ligand 1 inhibitor
Trastuzumab: anti-HER2 monoclonal antibody
Pertuzumab: anti-HER2 monoclonal antibody
|
|---|---|
|
pCR Rate in Patients With (PD-L1)-Positive and PD-L1-Negative Tumors
pCR rate due to DTP alone in the breast in patients with PD-L1-positive tumors
|
25.0 Percentage of Patients
|
|
pCR Rate in Patients With (PD-L1)-Positive and PD-L1-Negative Tumors
pCR rate due to DTP alone in the breast in patients with PD-L1-negative tumors
|
55.2 Percentage of Patients
|
SECONDARY outcome
Timeframe: 3 yearsDetermination of 3-year DFS rate in patients who achieve pCR
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 18 weeksPopulation: 32 of 39 patients had adverse events. 22 of those patients had treatment related adverse events.
Number of participants with treatment-related adverse events, as assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events v5.0
Outcome measures
| Measure |
Durvalumab + Trastuzumab + Pertuzumab
n=39 Participants
Durvalumab, trastuzumab, and pertuzumab will be administered on Day 1 every 3 weeks for 6 cycles. Trastuzumab will be administered as 8 mg/kg intravenous (IV) loading dose, followed by 6 mg/kg IV. Pertuzumab will be administered as 840 mg IV loading dose, followed by 420 mg. Durvalumab will be administered at a fixed dose of 1120 mg IV.
Durvalumab: programmed cell death-ligand 1 inhibitor
Trastuzumab: anti-HER2 monoclonal antibody
Pertuzumab: anti-HER2 monoclonal antibody
|
|---|---|
|
Number of Participants With Treatment-related Adverse Events
|
22 Participants
|
Adverse Events
Durvalumab + Trastuzumab + Pertuzumab
Serious events: 4 serious events
Other events: 32 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Durvalumab + Trastuzumab + Pertuzumab
n=39 participants at risk
Durvalumab, trastuzumab, and pertuzumab will be administered on Day 1 every 3 weeks for 6 cycles. Trastuzumab will be administered as 8 mg/kg intravenous (IV) loading dose, followed by 6 mg/kg IV. Pertuzumab will be administered as 840 mg IV loading dose, followed by 420 mg. Durvalumab will be administered at a fixed dose of 1120 mg IV.
Durvalumab: programmed cell death-ligand 1 inhibitor
Trastuzumab: anti-HER2 monoclonal antibody
Pertuzumab: anti-HER2 monoclonal antibody
|
|---|---|
|
Skin and subcutaneous tissue disorders
Skin Infection
|
2.6%
1/39 • Number of events 1 • Approximately 20 Months, collected from signing of informed consent to 30 days after last treatment dose.
Adverse events were reported in the results as Number of Patients affected, but did not report number of events. Number of patients affected was entered for both the number of patients affected field and the number of events field.
|
|
Skin and subcutaneous tissue disorders
Left Breast Cellulitis
|
2.6%
1/39 • Number of events 1 • Approximately 20 Months, collected from signing of informed consent to 30 days after last treatment dose.
Adverse events were reported in the results as Number of Patients affected, but did not report number of events. Number of patients affected was entered for both the number of patients affected field and the number of events field.
|
|
Psychiatric disorders
Anxiety
|
2.6%
1/39 • Number of events 1 • Approximately 20 Months, collected from signing of informed consent to 30 days after last treatment dose.
Adverse events were reported in the results as Number of Patients affected, but did not report number of events. Number of patients affected was entered for both the number of patients affected field and the number of events field.
|
|
Cardiac disorders
Cardiac Arrest
|
2.6%
1/39 • Number of events 1 • Approximately 20 Months, collected from signing of informed consent to 30 days after last treatment dose.
Adverse events were reported in the results as Number of Patients affected, but did not report number of events. Number of patients affected was entered for both the number of patients affected field and the number of events field.
|
Other adverse events
| Measure |
Durvalumab + Trastuzumab + Pertuzumab
n=39 participants at risk
Durvalumab, trastuzumab, and pertuzumab will be administered on Day 1 every 3 weeks for 6 cycles. Trastuzumab will be administered as 8 mg/kg intravenous (IV) loading dose, followed by 6 mg/kg IV. Pertuzumab will be administered as 840 mg IV loading dose, followed by 420 mg. Durvalumab will be administered at a fixed dose of 1120 mg IV.
Durvalumab: programmed cell death-ligand 1 inhibitor
Trastuzumab: anti-HER2 monoclonal antibody
Pertuzumab: anti-HER2 monoclonal antibody
|
|---|---|
|
Gastrointestinal disorders
Abdominal Pain
|
17.9%
7/39 • Number of events 7 • Approximately 20 Months, collected from signing of informed consent to 30 days after last treatment dose.
Adverse events were reported in the results as Number of Patients affected, but did not report number of events. Number of patients affected was entered for both the number of patients affected field and the number of events field.
|
|
Gastrointestinal disorders
Diarrhea
|
66.7%
26/39 • Number of events 26 • Approximately 20 Months, collected from signing of informed consent to 30 days after last treatment dose.
Adverse events were reported in the results as Number of Patients affected, but did not report number of events. Number of patients affected was entered for both the number of patients affected field and the number of events field.
|
|
Gastrointestinal disorders
Nausea
|
28.2%
11/39 • Number of events 11 • Approximately 20 Months, collected from signing of informed consent to 30 days after last treatment dose.
Adverse events were reported in the results as Number of Patients affected, but did not report number of events. Number of patients affected was entered for both the number of patients affected field and the number of events field.
|
|
Gastrointestinal disorders
Constipation
|
15.4%
6/39 • Number of events 6 • Approximately 20 Months, collected from signing of informed consent to 30 days after last treatment dose.
Adverse events were reported in the results as Number of Patients affected, but did not report number of events. Number of patients affected was entered for both the number of patients affected field and the number of events field.
|
|
Gastrointestinal disorders
Vomiting
|
12.8%
5/39 • Number of events 5 • Approximately 20 Months, collected from signing of informed consent to 30 days after last treatment dose.
Adverse events were reported in the results as Number of Patients affected, but did not report number of events. Number of patients affected was entered for both the number of patients affected field and the number of events field.
|
|
General disorders
Fatigue
|
48.7%
19/39 • Number of events 19 • Approximately 20 Months, collected from signing of informed consent to 30 days after last treatment dose.
Adverse events were reported in the results as Number of Patients affected, but did not report number of events. Number of patients affected was entered for both the number of patients affected field and the number of events field.
|
|
General disorders
Fever
|
20.5%
8/39 • Number of events 8 • Approximately 20 Months, collected from signing of informed consent to 30 days after last treatment dose.
Adverse events were reported in the results as Number of Patients affected, but did not report number of events. Number of patients affected was entered for both the number of patients affected field and the number of events field.
|
|
General disorders
Flu-like Symptoms
|
17.9%
7/39 • Number of events 7 • Approximately 20 Months, collected from signing of informed consent to 30 days after last treatment dose.
Adverse events were reported in the results as Number of Patients affected, but did not report number of events. Number of patients affected was entered for both the number of patients affected field and the number of events field.
|
|
Skin and subcutaneous tissue disorders
Rash
|
41.0%
16/39 • Number of events 16 • Approximately 20 Months, collected from signing of informed consent to 30 days after last treatment dose.
Adverse events were reported in the results as Number of Patients affected, but did not report number of events. Number of patients affected was entered for both the number of patients affected field and the number of events field.
|
|
Skin and subcutaneous tissue disorders
Dry Skin
|
20.5%
8/39 • Number of events 8 • Approximately 20 Months, collected from signing of informed consent to 30 days after last treatment dose.
Adverse events were reported in the results as Number of Patients affected, but did not report number of events. Number of patients affected was entered for both the number of patients affected field and the number of events field.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
12.8%
5/39 • Number of events 5 • Approximately 20 Months, collected from signing of informed consent to 30 days after last treatment dose.
Adverse events were reported in the results as Number of Patients affected, but did not report number of events. Number of patients affected was entered for both the number of patients affected field and the number of events field.
|
|
Musculoskeletal and connective tissue disorders
Myaligia
|
35.9%
14/39 • Number of events 14 • Approximately 20 Months, collected from signing of informed consent to 30 days after last treatment dose.
Adverse events were reported in the results as Number of Patients affected, but did not report number of events. Number of patients affected was entered for both the number of patients affected field and the number of events field.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
15.4%
6/39 • Number of events 6 • Approximately 20 Months, collected from signing of informed consent to 30 days after last treatment dose.
Adverse events were reported in the results as Number of Patients affected, but did not report number of events. Number of patients affected was entered for both the number of patients affected field and the number of events field.
|
|
Investigations
Transaminitis
|
30.8%
12/39 • Number of events 12 • Approximately 20 Months, collected from signing of informed consent to 30 days after last treatment dose.
Adverse events were reported in the results as Number of Patients affected, but did not report number of events. Number of patients affected was entered for both the number of patients affected field and the number of events field.
|
|
Investigations
TSH Alterations
|
25.6%
10/39 • Number of events 10 • Approximately 20 Months, collected from signing of informed consent to 30 days after last treatment dose.
Adverse events were reported in the results as Number of Patients affected, but did not report number of events. Number of patients affected was entered for both the number of patients affected field and the number of events field.
|
|
Investigations
Creatine Increase
|
15.4%
6/39 • Number of events 6 • Approximately 20 Months, collected from signing of informed consent to 30 days after last treatment dose.
Adverse events were reported in the results as Number of Patients affected, but did not report number of events. Number of patients affected was entered for both the number of patients affected field and the number of events field.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
10.3%
4/39 • Number of events 4 • Approximately 20 Months, collected from signing of informed consent to 30 days after last treatment dose.
Adverse events were reported in the results as Number of Patients affected, but did not report number of events. Number of patients affected was entered for both the number of patients affected field and the number of events field.
|
|
Metabolism and nutrition disorders
Hyperuricemia
|
10.3%
4/39 • Number of events 4 • Approximately 20 Months, collected from signing of informed consent to 30 days after last treatment dose.
Adverse events were reported in the results as Number of Patients affected, but did not report number of events. Number of patients affected was entered for both the number of patients affected field and the number of events field.
|
|
Blood and lymphatic system disorders
Anemia
|
25.6%
10/39 • Number of events 10 • Approximately 20 Months, collected from signing of informed consent to 30 days after last treatment dose.
Adverse events were reported in the results as Number of Patients affected, but did not report number of events. Number of patients affected was entered for both the number of patients affected field and the number of events field.
|
|
Nervous system disorders
Headache
|
23.1%
9/39 • Number of events 9 • Approximately 20 Months, collected from signing of informed consent to 30 days after last treatment dose.
Adverse events were reported in the results as Number of Patients affected, but did not report number of events. Number of patients affected was entered for both the number of patients affected field and the number of events field.
|
|
Psychiatric disorders
Insomnia
|
17.9%
7/39 • Number of events 7 • Approximately 20 Months, collected from signing of informed consent to 30 days after last treatment dose.
Adverse events were reported in the results as Number of Patients affected, but did not report number of events. Number of patients affected was entered for both the number of patients affected field and the number of events field.
|
|
Psychiatric disorders
Anxiety/Depression
|
12.8%
5/39 • Number of events 5 • Approximately 20 Months, collected from signing of informed consent to 30 days after last treatment dose.
Adverse events were reported in the results as Number of Patients affected, but did not report number of events. Number of patients affected was entered for both the number of patients affected field and the number of events field.
|
|
Infections and infestations
Urinary Tract Infection
|
10.3%
4/39 • Number of events 4 • Approximately 20 Months, collected from signing of informed consent to 30 days after last treatment dose.
Adverse events were reported in the results as Number of Patients affected, but did not report number of events. Number of patients affected was entered for both the number of patients affected field and the number of events field.
|
|
Infections and infestations
Skin/Nail Infection
|
7.7%
3/39 • Number of events 3 • Approximately 20 Months, collected from signing of informed consent to 30 days after last treatment dose.
Adverse events were reported in the results as Number of Patients affected, but did not report number of events. Number of patients affected was entered for both the number of patients affected field and the number of events field.
|
|
Vascular disorders
Hypertension
|
12.8%
5/39 • Number of events 5 • Approximately 20 Months, collected from signing of informed consent to 30 days after last treatment dose.
Adverse events were reported in the results as Number of Patients affected, but did not report number of events. Number of patients affected was entered for both the number of patients affected field and the number of events field.
|
|
Eye disorders
Eye soreness/blurred vision
|
10.3%
4/39 • Number of events 4 • Approximately 20 Months, collected from signing of informed consent to 30 days after last treatment dose.
Adverse events were reported in the results as Number of Patients affected, but did not report number of events. Number of patients affected was entered for both the number of patients affected field and the number of events field.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
5.1%
2/39 • Number of events 2 • Approximately 20 Months, collected from signing of informed consent to 30 days after last treatment dose.
Adverse events were reported in the results as Number of Patients affected, but did not report number of events. Number of patients affected was entered for both the number of patients affected field and the number of events field.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
5.1%
2/39 • Number of events 2 • Approximately 20 Months, collected from signing of informed consent to 30 days after last treatment dose.
Adverse events were reported in the results as Number of Patients affected, but did not report number of events. Number of patients affected was entered for both the number of patients affected field and the number of events field.
|
|
Ear and labyrinth disorders
Dizziness/Vertigo
|
7.7%
3/39 • Number of events 3 • Approximately 20 Months, collected from signing of informed consent to 30 days after last treatment dose.
Adverse events were reported in the results as Number of Patients affected, but did not report number of events. Number of patients affected was entered for both the number of patients affected field and the number of events field.
|
|
Nervous system disorders
Tremor
|
5.1%
2/39 • Number of events 2 • Approximately 20 Months, collected from signing of informed consent to 30 days after last treatment dose.
Adverse events were reported in the results as Number of Patients affected, but did not report number of events. Number of patients affected was entered for both the number of patients affected field and the number of events field.
|
|
Vascular disorders
Hot Flashes
|
5.1%
2/39 • Number of events 2 • Approximately 20 Months, collected from signing of informed consent to 30 days after last treatment dose.
Adverse events were reported in the results as Number of Patients affected, but did not report number of events. Number of patients affected was entered for both the number of patients affected field and the number of events field.
|
|
Nervous system disorders
Dysguesia
|
7.7%
3/39 • Number of events 3 • Approximately 20 Months, collected from signing of informed consent to 30 days after last treatment dose.
Adverse events were reported in the results as Number of Patients affected, but did not report number of events. Number of patients affected was entered for both the number of patients affected field and the number of events field.
|
|
Gastrointestinal disorders
Dyspepsia
|
5.1%
2/39 • Number of events 2 • Approximately 20 Months, collected from signing of informed consent to 30 days after last treatment dose.
Adverse events were reported in the results as Number of Patients affected, but did not report number of events. Number of patients affected was entered for both the number of patients affected field and the number of events field.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
5.1%
2/39 • Number of events 2 • Approximately 20 Months, collected from signing of informed consent to 30 days after last treatment dose.
Adverse events were reported in the results as Number of Patients affected, but did not report number of events. Number of patients affected was entered for both the number of patients affected field and the number of events field.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
7.7%
3/39 • Number of events 3 • Approximately 20 Months, collected from signing of informed consent to 30 days after last treatment dose.
Adverse events were reported in the results as Number of Patients affected, but did not report number of events. Number of patients affected was entered for both the number of patients affected field and the number of events field.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
7.7%
3/39 • Number of events 3 • Approximately 20 Months, collected from signing of informed consent to 30 days after last treatment dose.
Adverse events were reported in the results as Number of Patients affected, but did not report number of events. Number of patients affected was entered for both the number of patients affected field and the number of events field.
|
|
Investigations
Elevated LDH
|
7.7%
3/39 • Number of events 3 • Approximately 20 Months, collected from signing of informed consent to 30 days after last treatment dose.
Adverse events were reported in the results as Number of Patients affected, but did not report number of events. Number of patients affected was entered for both the number of patients affected field and the number of events field.
|
|
Renal and urinary disorders
Elevated Creatinine
|
15.4%
6/39 • Number of events 6 • Approximately 20 Months, collected from signing of informed consent to 30 days after last treatment dose.
Adverse events were reported in the results as Number of Patients affected, but did not report number of events. Number of patients affected was entered for both the number of patients affected field and the number of events field.
|
|
Gastrointestinal disorders
Elevated Amylase/Lipase
|
5.1%
2/39 • Number of events 2 • Approximately 20 Months, collected from signing of informed consent to 30 days after last treatment dose.
Adverse events were reported in the results as Number of Patients affected, but did not report number of events. Number of patients affected was entered for both the number of patients affected field and the number of events field.
|
|
Blood and lymphatic system disorders
Leukopenia
|
5.1%
2/39 • Number of events 2 • Approximately 20 Months, collected from signing of informed consent to 30 days after last treatment dose.
Adverse events were reported in the results as Number of Patients affected, but did not report number of events. Number of patients affected was entered for both the number of patients affected field and the number of events field.
|
|
Blood and lymphatic system disorders
Lymphocyte count decrease
|
7.7%
3/39 • Number of events 3 • Approximately 20 Months, collected from signing of informed consent to 30 days after last treatment dose.
Adverse events were reported in the results as Number of Patients affected, but did not report number of events. Number of patients affected was entered for both the number of patients affected field and the number of events field.
|
|
Cardiac disorders
Hypotension
|
5.1%
2/39 • Number of events 2 • Approximately 20 Months, collected from signing of informed consent to 30 days after last treatment dose.
Adverse events were reported in the results as Number of Patients affected, but did not report number of events. Number of patients affected was entered for both the number of patients affected field and the number of events field.
|
|
Metabolism and nutrition disorders
Edema
|
5.1%
2/39 • Number of events 2 • Approximately 20 Months, collected from signing of informed consent to 30 days after last treatment dose.
Adverse events were reported in the results as Number of Patients affected, but did not report number of events. Number of patients affected was entered for both the number of patients affected field and the number of events field.
|
|
Respiratory, thoracic and mediastinal disorders
Sore Throat
|
5.1%
2/39 • Number of events 2 • Approximately 20 Months, collected from signing of informed consent to 30 days after last treatment dose.
Adverse events were reported in the results as Number of Patients affected, but did not report number of events. Number of patients affected was entered for both the number of patients affected field and the number of events field.
|
|
Respiratory, thoracic and mediastinal disorders
Flu like symptoms/nasal congestion
|
17.9%
7/39 • Number of events 7 • Approximately 20 Months, collected from signing of informed consent to 30 days after last treatment dose.
Adverse events were reported in the results as Number of Patients affected, but did not report number of events. Number of patients affected was entered for both the number of patients affected field and the number of events field.
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Additional Information
Polly Niravath, M.D.
Houston Methodist Neal Cancer Center
Phone: 7134418324
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place