Trial Outcomes & Findings for Trial of Nivolumab With Chemotherapy as Neoadjuvant Treatment in Inflammatory Breast Cancer (IBC) (NCT NCT03742986)
NCT ID: NCT03742986
Last Updated: 2023-12-19
Results Overview
pCR is defined as no histologic evidence of invasive tumor cells in the surgical breast specimen, axillary nodes, or sentinel node identified after neoadjuvant chemotherapy (ypT0/Tis ypN0).
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
8 participants
Primary outcome timeframe
up to 16 weeks
Results posted on
2023-12-19
Participant Flow
Participant milestones
| Measure |
HER2-negative, Including TNBC or HR-positive
Nivolumab 360mg: Nivolumab 360 mg IV on Day 1 of every 21 day cycle (Cycle 1-4)
Paclitaxel 80mg/m\^2: Paclitaxel 80mg/m\^2 IV on Day of 1, 8, 15 of every 21 day cycle (Cycle 1-4)
Doxorubicin 60mg/m\^2: Doxorubicin 60 mg/m\^2 IV on Day 1 of every 14 day cycle (Cycle 5-8)
Cyclophosphamide 600mg/m\^2: Cyclophosphamide 600mg/m\^2 on Day 1 of every 14 day cycle (Cycle 5-8)
|
HER2-positive, Independent of HR Status
Nivolumab 360mg: Nivolumab 360 mg IV on Day 1 of every 21 day cycle (Cycle 1-4)
Doxorubicin 60mg/m\^2: Doxorubicin 60 mg/m\^2 IV on Day 1 of every 14 day cycle (Cycle 5-8)
Cyclophosphamide 600mg/m\^2: Cyclophosphamide 600mg/m\^2 on Day 1 of every 14 day cycle (Cycle 5-8)
Paclitaxel 80mg/m\^2 or Docetaxel 75mg/m\^2: Paclitaxel 80mg/m\^2 on Day 1, 8, 15 of every 21 day cycle (Cycle 1-4) OR Docetaxel 75mg/m\^2 on Day 1 of every 21 day cycle (Cycle 1-4)
Trastuzumab 8mg/kg and 6 mg/kg: Trastuzumab 8mg/kg IV on Day 1 of Cycle 1 and then 6mg/kg IV on Day 1 of Cycle 2-4
Pertuzumab 840mg and 420mg: Pertuzumab 840mg on Day 1 of Cycle 1 and then 420mg IV on Day 1 of Cycle 2-4
|
|---|---|---|
|
Overall Study
STARTED
|
4
|
4
|
|
Overall Study
COMPLETED
|
4
|
4
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Trial of Nivolumab With Chemotherapy as Neoadjuvant Treatment in Inflammatory Breast Cancer (IBC)
Baseline characteristics by cohort
| Measure |
HER2-negative, Including TNBC or HR-positive
n=4 Participants
Nivolumab 360mg: Nivolumab 360 mg IV on Day 1 of every 21 day cycle (Cycle 1-4)
Paclitaxel 80mg/m\^2: Paclitaxel 80mg/m\^2 IV on Day of 1, 8, 15 of every 21 day cycle (Cycle 1-4)
Doxorubicin 60mg/m\^2: Doxorubicin 60 mg/m\^2 IV on Day 1 of every 14 day cycle (Cycle 5-8)
Cyclophosphamide 600mg/m\^2: Cyclophosphamide 600mg/m\^2 on Day 1 of every 14 day cycle (Cycle 5-8)
|
HER2-positive, Independent of HR Status
n=4 Participants
Nivolumab 360mg: Nivolumab 360 mg IV on Day 1 of every 21 day cycle (Cycle 1-4)
Doxorubicin 60mg/m\^2: Doxorubicin 60 mg/m\^2 IV on Day 1 of every 14 day cycle (Cycle 5-8)
Cyclophosphamide 600mg/m\^2: Cyclophosphamide 600mg/m\^2 on Day 1 of every 14 day cycle (Cycle 5-8)
Paclitaxel 80mg/m\^2 or Docetaxel 75mg/m\^2: Paclitaxel 80mg/m\^2 on Day 1, 8, 15 of every 21 day cycle (Cycle 1-4) OR Docetaxel 75mg/m\^2 on Day 1 of every 21 day cycle (Cycle 1-4)
Trastuzumab 8mg/kg and 6 mg/kg: Trastuzumab 8mg/kg IV on Day 1 of Cycle 1 and then 6mg/kg IV on Day 1 of Cycle 2-4
Pertuzumab 840mg and 420mg: Pertuzumab 840mg on Day 1 of Cycle 1 and then 420mg IV on Day 1 of Cycle 2-4
|
Total
n=8 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
68.2 years
n=5 Participants
|
49.75 years
n=7 Participants
|
59 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
4 participants
n=5 Participants
|
4 participants
n=7 Participants
|
8 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: up to 16 weekspCR is defined as no histologic evidence of invasive tumor cells in the surgical breast specimen, axillary nodes, or sentinel node identified after neoadjuvant chemotherapy (ypT0/Tis ypN0).
Outcome measures
| Measure |
HER2-negative, Including TNBC or HR-positive
n=4 Participants
Nivolumab 360mg: Nivolumab 360 mg IV on Day 1 of every 21 day cycle (Cycle 1-4)
Paclitaxel 80mg/m\^2: Paclitaxel 80mg/m\^2 IV on Day of 1, 8, 15 of every 21 day cycle (Cycle 1-4)
Doxorubicin 60mg/m\^2: Doxorubicin 60 mg/m\^2 IV on Day 1 of every 14 day cycle (Cycle 5-8)
Cyclophosphamide 600mg/m\^2: Cyclophosphamide 600mg/m\^2 on Day 1 of every 14 day cycle (Cycle 5-8)
|
HER2-positive, Independent of HR Status
n=4 Participants
Nivolumab 360mg: Nivolumab 360 mg IV on Day 1 of every 21 day cycle (Cycle 1-4)
Doxorubicin 60mg/m\^2: Doxorubicin 60 mg/m\^2 IV on Day 1 of every 14 day cycle (Cycle 5-8)
Cyclophosphamide 600mg/m\^2: Cyclophosphamide 600mg/m\^2 on Day 1 of every 14 day cycle (Cycle 5-8)
Paclitaxel 80mg/m\^2 or Docetaxel 75mg/m\^2: Paclitaxel 80mg/m\^2 on Day 1, 8, 15 of every 21 day cycle (Cycle 1-4) OR Docetaxel 75mg/m\^2 on Day 1 of every 21 day cycle (Cycle 1-4)
Trastuzumab 8mg/kg and 6 mg/kg: Trastuzumab 8mg/kg IV on Day 1 of Cycle 1 and then 6mg/kg IV on Day 1 of Cycle 2-4
Pertuzumab 840mg and 420mg: Pertuzumab 840mg on Day 1 of Cycle 1 and then 420mg IV on Day 1 of Cycle 2-4
|
|---|---|---|
|
Number of Participants Who Had a Pathological Complete Response (pCR)
|
0 Participants
|
3 Participants
|
PRIMARY outcome
Timeframe: up to 1 yearpCR is defined as no histologic evidence of invasive tumor cells in the surgical breast specimen, axillary nodes, or sentinel node identified after neoadjuvant chemotherapy (ypT0/Tis ypN0).
Outcome measures
| Measure |
HER2-negative, Including TNBC or HR-positive
n=4 Participants
Nivolumab 360mg: Nivolumab 360 mg IV on Day 1 of every 21 day cycle (Cycle 1-4)
Paclitaxel 80mg/m\^2: Paclitaxel 80mg/m\^2 IV on Day of 1, 8, 15 of every 21 day cycle (Cycle 1-4)
Doxorubicin 60mg/m\^2: Doxorubicin 60 mg/m\^2 IV on Day 1 of every 14 day cycle (Cycle 5-8)
Cyclophosphamide 600mg/m\^2: Cyclophosphamide 600mg/m\^2 on Day 1 of every 14 day cycle (Cycle 5-8)
|
HER2-positive, Independent of HR Status
n=4 Participants
Nivolumab 360mg: Nivolumab 360 mg IV on Day 1 of every 21 day cycle (Cycle 1-4)
Doxorubicin 60mg/m\^2: Doxorubicin 60 mg/m\^2 IV on Day 1 of every 14 day cycle (Cycle 5-8)
Cyclophosphamide 600mg/m\^2: Cyclophosphamide 600mg/m\^2 on Day 1 of every 14 day cycle (Cycle 5-8)
Paclitaxel 80mg/m\^2 or Docetaxel 75mg/m\^2: Paclitaxel 80mg/m\^2 on Day 1, 8, 15 of every 21 day cycle (Cycle 1-4) OR Docetaxel 75mg/m\^2 on Day 1 of every 21 day cycle (Cycle 1-4)
Trastuzumab 8mg/kg and 6 mg/kg: Trastuzumab 8mg/kg IV on Day 1 of Cycle 1 and then 6mg/kg IV on Day 1 of Cycle 2-4
Pertuzumab 840mg and 420mg: Pertuzumab 840mg on Day 1 of Cycle 1 and then 420mg IV on Day 1 of Cycle 2-4
|
|---|---|---|
|
Number of Participants Who Had a Pathological Complete Response (pCR)
|
1 Participants
|
3 Participants
|
Adverse Events
HER2-negative, Including TNBC or HR-positive
Serious events: 1 serious events
Other events: 4 other events
Deaths: 0 deaths
HER2-positive, Independent of HR Status
Serious events: 3 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
HER2-negative, Including TNBC or HR-positive
n=4 participants at risk
Nivolumab 360mg: Nivolumab 360 mg IV on Day 1 of every 21 day cycle (Cycle 1-4)
Paclitaxel 80mg/m\^2: Paclitaxel 80mg/m\^2 IV on Day of 1, 8, 15 of every 21 day cycle (Cycle 1-4)
Doxorubicin 60mg/m\^2: Doxorubicin 60 mg/m\^2 IV on Day 1 of every 14 day cycle (Cycle 5-8)
Cyclophosphamide 600mg/m\^2: Cyclophosphamide 600mg/m\^2 on Day 1 of every 14 day cycle (Cycle 5-8)
|
HER2-positive, Independent of HR Status
n=4 participants at risk
Nivolumab 360mg: Nivolumab 360 mg IV on Day 1 of every 21 day cycle (Cycle 1-4)
Doxorubicin 60mg/m\^2: Doxorubicin 60 mg/m\^2 IV on Day 1 of every 14 day cycle (Cycle 5-8)
Cyclophosphamide 600mg/m\^2: Cyclophosphamide 600mg/m\^2 on Day 1 of every 14 day cycle (Cycle 5-8)
Paclitaxel 80mg/m\^2 or Docetaxel 75mg/m\^2: Paclitaxel 80mg/m\^2 on Day 1, 8, 15 of every 21 day cycle (Cycle 1-4) OR Docetaxel 75mg/m\^2 on Day 1 of every 21 day cycle (Cycle 1-4)
Trastuzumab 8mg/kg and 6 mg/kg: Trastuzumab 8mg/kg IV on Day 1 of Cycle 1 and then 6mg/kg IV on Day 1 of Cycle 2-4
Pertuzumab 840mg and 420mg: Pertuzumab 840mg on Day 1 of Cycle 1 and then 420mg IV on Day 1 of Cycle 2-4
|
|---|---|---|
|
Blood and lymphatic system disorders
Febrile Neutropenia
|
0.00%
0/4 • 16 weeks
|
25.0%
1/4 • 16 weeks
|
|
General disorders
Fever
|
0.00%
0/4 • 16 weeks
|
25.0%
1/4 • 16 weeks
|
|
General disorders
Allergic Reaction
|
0.00%
0/4 • 16 weeks
|
25.0%
1/4 • 16 weeks
|
|
Infections and infestations
Mediport Site Sepsis
|
0.00%
0/4 • 16 weeks
|
25.0%
1/4 • 16 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Shortness of Breath (Dyspnea)
|
25.0%
1/4 • 16 weeks
|
0.00%
0/4 • 16 weeks
|
Other adverse events
| Measure |
HER2-negative, Including TNBC or HR-positive
n=4 participants at risk
Nivolumab 360mg: Nivolumab 360 mg IV on Day 1 of every 21 day cycle (Cycle 1-4)
Paclitaxel 80mg/m\^2: Paclitaxel 80mg/m\^2 IV on Day of 1, 8, 15 of every 21 day cycle (Cycle 1-4)
Doxorubicin 60mg/m\^2: Doxorubicin 60 mg/m\^2 IV on Day 1 of every 14 day cycle (Cycle 5-8)
Cyclophosphamide 600mg/m\^2: Cyclophosphamide 600mg/m\^2 on Day 1 of every 14 day cycle (Cycle 5-8)
|
HER2-positive, Independent of HR Status
n=4 participants at risk
Nivolumab 360mg: Nivolumab 360 mg IV on Day 1 of every 21 day cycle (Cycle 1-4)
Doxorubicin 60mg/m\^2: Doxorubicin 60 mg/m\^2 IV on Day 1 of every 14 day cycle (Cycle 5-8)
Cyclophosphamide 600mg/m\^2: Cyclophosphamide 600mg/m\^2 on Day 1 of every 14 day cycle (Cycle 5-8)
Paclitaxel 80mg/m\^2 or Docetaxel 75mg/m\^2: Paclitaxel 80mg/m\^2 on Day 1, 8, 15 of every 21 day cycle (Cycle 1-4) OR Docetaxel 75mg/m\^2 on Day 1 of every 21 day cycle (Cycle 1-4)
Trastuzumab 8mg/kg and 6 mg/kg: Trastuzumab 8mg/kg IV on Day 1 of Cycle 1 and then 6mg/kg IV on Day 1 of Cycle 2-4
Pertuzumab 840mg and 420mg: Pertuzumab 840mg on Day 1 of Cycle 1 and then 420mg IV on Day 1 of Cycle 2-4
|
|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
50.0%
2/4 • 16 weeks
|
25.0%
1/4 • 16 weeks
|
|
Blood and lymphatic system disorders
Febrile Neutropenia
|
100.0%
4/4 • 16 weeks
|
100.0%
4/4 • 16 weeks
|
|
Cardiac disorders
Atrial Fibrilation
|
100.0%
4/4 • 16 weeks
|
25.0%
1/4 • 16 weeks
|
|
Cardiac disorders
Myocardial Infarction
|
75.0%
3/4 • 16 weeks
|
100.0%
4/4 • 16 weeks
|
|
Cardiac disorders
Palpitations
|
75.0%
3/4 • 16 weeks
|
75.0%
3/4 • 16 weeks
|
|
Cardiac disorders
Sinus Tachycardia
|
100.0%
4/4 • 16 weeks
|
75.0%
3/4 • 16 weeks
|
|
Gastrointestinal disorders
Abdominal Pain
|
75.0%
3/4 • 16 weeks
|
75.0%
3/4 • 16 weeks
|
|
Gastrointestinal disorders
Colitis
|
75.0%
3/4 • 16 weeks
|
75.0%
3/4 • 16 weeks
|
|
Gastrointestinal disorders
Constipation
|
75.0%
3/4 • 16 weeks
|
75.0%
3/4 • 16 weeks
|
|
Gastrointestinal disorders
Stomach Pain
|
100.0%
4/4 • 16 weeks
|
75.0%
3/4 • 16 weeks
|
|
Gastrointestinal disorders
Gastroesophageal Reflux Disease
|
50.0%
2/4 • 16 weeks
|
50.0%
2/4 • 16 weeks
|
|
Investigations
Alanine Aminotransferase Increased
|
75.0%
3/4 • 16 weeks
|
25.0%
1/4 • 16 weeks
|
|
General disorders
Allergic Reaction
|
100.0%
4/4 • 16 weeks
|
50.0%
2/4 • 16 weeks
|
|
Metabolism and nutrition disorders
Anorexia
|
100.0%
4/4 • 16 weeks
|
75.0%
3/4 • 16 weeks
|
|
Psychiatric disorders
Anxiety
|
100.0%
4/4 • 16 weeks
|
75.0%
3/4 • 16 weeks
|
|
Investigations
Aspartate Aminotransferase Increased
|
75.0%
3/4 • 16 weeks
|
50.0%
2/4 • 16 weeks
|
|
Investigations
Blood Bilirubin Increased
|
100.0%
4/4 • 16 weeks
|
75.0%
3/4 • 16 weeks
|
|
Musculoskeletal and connective tissue disorders
Bone Pain
|
100.0%
4/4 • 16 weeks
|
75.0%
3/4 • 16 weeks
|
|
General disorders
Chills
|
75.0%
3/4 • 16 weeks
|
75.0%
3/4 • 16 weeks
|
|
General disorders
Confusion
|
100.0%
4/4 • 16 weeks
|
75.0%
3/4 • 16 weeks
|
|
Psychiatric disorders
Depression
|
75.0%
3/4 • 16 weeks
|
100.0%
4/4 • 16 weeks
|
|
Nervous system disorders
Dizziness
|
50.0%
2/4 • 16 weeks
|
50.0%
2/4 • 16 weeks
|
|
Eye disorders
Dry Eye
|
100.0%
4/4 • 16 weeks
|
75.0%
3/4 • 16 weeks
|
|
Gastrointestinal disorders
Dry mouth
|
100.0%
4/4 • 16 weeks
|
75.0%
3/4 • 16 weeks
|
|
Nervous system disorders
Dysgeusia
|
75.0%
3/4 • 16 weeks
|
50.0%
2/4 • 16 weeks
|
|
Investigations
Neutrophil Count Decreased
|
50.0%
2/4 • 16 weeks
|
50.0%
2/4 • 16 weeks
|
|
Musculoskeletal and connective tissue disorders
Pain in Extremity
|
75.0%
3/4 • 16 weeks
|
75.0%
3/4 • 16 weeks
|
|
Investigations
Platelet Count Decreased
|
75.0%
3/4 • 16 weeks
|
75.0%
3/4 • 16 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Productive Cough
|
75.0%
3/4 • 16 weeks
|
100.0%
4/4 • 16 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Sore Throat
|
75.0%
3/4 • 16 weeks
|
50.0%
2/4 • 16 weeks
|
|
Nervous system disorders
Syncope
|
100.0%
4/4 • 16 weeks
|
75.0%
3/4 • 16 weeks
|
|
Gastrointestinal disorders
Vomiting
|
100.0%
4/4 • 16 weeks
|
25.0%
1/4 • 16 weeks
|
|
Investigations
White Blood Cell Decreased
|
50.0%
2/4 • 16 weeks
|
75.0%
3/4 • 16 weeks
|
|
General disorders
Edema Face
|
100.0%
4/4 • 16 weeks
|
75.0%
3/4 • 16 weeks
|
|
General disorders
Edema Limbs
|
50.0%
2/4 • 16 weeks
|
75.0%
3/4 • 16 weeks
|
|
General disorders
Fatigue
|
25.0%
1/4 • 16 weeks
|
0.00%
0/4 • 16 weeks
|
|
General disorders
Fever
|
100.0%
4/4 • 16 weeks
|
50.0%
2/4 • 16 weeks
|
|
Gastrointestinal disorders
Flatulence
|
100.0%
4/4 • 16 weeks
|
75.0%
3/4 • 16 weeks
|
|
Vascular disorders
Flushing
|
100.0%
4/4 • 16 weeks
|
75.0%
3/4 • 16 weeks
|
|
General disorders
General Disorders and Administration Site Conditions
|
75.0%
3/4 • 16 weeks
|
100.0%
4/4 • 16 weeks
|
|
Nervous system disorders
Headache
|
100.0%
4/4 • 16 weeks
|
50.0%
2/4 • 16 weeks
|
|
Vascular disorders
Hot Flashes
|
100.0%
4/4 • 16 weeks
|
75.0%
3/4 • 16 weeks
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
75.0%
3/4 • 16 weeks
|
75.0%
3/4 • 16 weeks
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
75.0%
3/4 • 16 weeks
|
100.0%
4/4 • 16 weeks
|
|
Metabolism and nutrition disorders
Hypokalemia
|
75.0%
3/4 • 16 weeks
|
25.0%
1/4 • 16 weeks
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
75.0%
3/4 • 16 weeks
|
100.0%
4/4 • 16 weeks
|
|
Vascular disorders
Hypotension
|
100.0%
4/4 • 16 weeks
|
50.0%
2/4 • 16 weeks
|
|
Metabolism and nutrition disorders
Hyponatremia
|
100.0%
4/4 • 16 weeks
|
75.0%
3/4 • 16 weeks
|
|
General disorders
Infusion Related Reaction
|
100.0%
4/4 • 16 weeks
|
50.0%
2/4 • 16 weeks
|
|
Investigations
Lymphocyte Count Decreased
|
50.0%
2/4 • 16 weeks
|
50.0%
2/4 • 16 weeks
|
|
General disorders
Malaise
|
75.0%
3/4 • 16 weeks
|
100.0%
4/4 • 16 weeks
|
|
Gastrointestinal disorders
Mucositis Oral
|
100.0%
4/4 • 16 weeks
|
50.0%
2/4 • 16 weeks
|
|
Musculoskeletal and connective tissue disorders
Muscle Cramp
|
75.0%
3/4 • 16 weeks
|
75.0%
3/4 • 16 weeks
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
50.0%
2/4 • 16 weeks
|
50.0%
2/4 • 16 weeks
|
|
Infections and infestations
Skin infection
|
50.0%
2/4 • 16 weeks
|
100.0%
4/4 • 16 weeks
|
|
Infections and infestations
Vaginal infection
|
75.0%
3/4 • 16 weeks
|
100.0%
4/4 • 16 weeks
|
|
Infections and infestations
Infections and Infestations
|
50.0%
2/4 • 16 weeks
|
50.0%
2/4 • 16 weeks
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
75.0%
3/4 • 16 weeks
|
100.0%
4/4 • 16 weeks
|
|
Musculoskeletal and connective tissue disorders
Other Musculoskeletal and Connective Tissue Disorders
|
75.0%
3/4 • 16 weeks
|
50.0%
2/4 • 16 weeks
|
|
Nervous system disorders
Peripheral Motor Neuropathy
|
75.0%
3/4 • 16 weeks
|
100.0%
4/4 • 16 weeks
|
|
Nervous system disorders
Peripheral Sensory Neuropathy
|
50.0%
2/4 • 16 weeks
|
50.0%
2/4 • 16 weeks
|
|
Renal and urinary disorders
Acute Kidney Injury
|
100.0%
4/4 • 16 weeks
|
75.0%
3/4 • 16 weeks
|
|
Renal and urinary disorders
Urinary Tract Infection
|
75.0%
3/4 • 16 weeks
|
100.0%
4/4 • 16 weeks
|
|
Reproductive system and breast disorders
Reproductive System and Breast Disorders
|
100.0%
4/4 • 16 weeks
|
75.0%
3/4 • 16 weeks
|
|
Skin and subcutaneous tissue disorders
Pruiritus
|
75.0%
3/4 • 16 weeks
|
100.0%
4/4 • 16 weeks
|
|
Skin and subcutaneous tissue disorders
Rash Acneiform
|
100.0%
4/4 • 16 weeks
|
75.0%
3/4 • 16 weeks
|
|
Skin and subcutaneous tissue disorders
Rash Maculo
|
100.0%
4/4 • 16 weeks
|
75.0%
3/4 • 16 weeks
|
|
Skin and subcutaneous tissue disorders
Skin Hypopigmentation
|
75.0%
3/4 • 16 weeks
|
100.0%
4/4 • 16 weeks
|
|
Skin and subcutaneous tissue disorders
Folliculitis
|
75.0%
3/4 • 16 weeks
|
75.0%
3/4 • 16 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
50.0%
2/4 • 16 weeks
|
75.0%
3/4 • 16 weeks
|
Additional Information
Maryann Kwa, MD
NYU Langone Health - Perlmutter Cancer Center
Phone: (212) 731-6364
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place