Trial Outcomes & Findings for Pembrolizumab and Carboplatin in Treating Patients With Circulating Tumor Cells Positive Metastatic Breast Cancer (NCT NCT03213041)
NCT ID: NCT03213041
Last Updated: 2026-06-17
Results Overview
PFS will be based on investigator assessment. PFS will be defined as the time from the first study treatment to the first occurrence of progression or death, and will be assessed every 9 weeks after beginning of treatment.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
12 participants
Primary outcome timeframe
Every 9 weeks from the first study treatment, assessed up to 3 years
Results posted on
2026-06-17
Participant Flow
Participant milestones
| Measure |
Treatment (Pembrolizumab, Carboplatin)
Patients receive pembrolizumab IV over 30 minutes on day 1 and carboplatin IV over 30-60 minutes on day 1 beginning with course 3. Courses repeat every 21 days for 24 months in the absence of disease progression or unacceptable toxicity.
Carboplatin: Given IV
Laboratory Biomarker Analysis: Correlative studies
Pembrolizumab: Given IV
|
|---|---|
|
Screening - 1st Response Assessment
STARTED
|
12
|
|
Screening - 1st Response Assessment
Cycle 1
|
9
|
|
Screening - 1st Response Assessment
Cycle 2
|
9
|
|
Screening - 1st Response Assessment
Cycle 3
|
8
|
|
Screening - 1st Response Assessment
COMPLETED
|
8
|
|
Screening - 1st Response Assessment
NOT COMPLETED
|
4
|
|
Study Treatment Period: Cycles 4-6
STARTED
|
8
|
|
Study Treatment Period: Cycles 4-6
Cycle 4
|
5
|
|
Study Treatment Period: Cycles 4-6
Cycle 5
|
4
|
|
Study Treatment Period: Cycles 4-6
Cycle 6
|
3
|
|
Study Treatment Period: Cycles 4-6
COMPLETED
|
3
|
|
Study Treatment Period: Cycles 4-6
NOT COMPLETED
|
5
|
|
Study Treatment Period: Cycles 7- 9+
STARTED
|
3
|
|
Study Treatment Period: Cycles 7- 9+
Cycle 7
|
3
|
|
Study Treatment Period: Cycles 7- 9+
Cycle 8
|
3
|
|
Study Treatment Period: Cycles 7- 9+
Cycle 8 and Beyond
|
2
|
|
Study Treatment Period: Cycles 7- 9+
COMPLETED
|
2
|
|
Study Treatment Period: Cycles 7- 9+
NOT COMPLETED
|
1
|
|
Survival Follow-Up
STARTED
|
10
|
|
Survival Follow-Up
COMPLETED
|
10
|
|
Survival Follow-Up
NOT COMPLETED
|
0
|
Reasons for withdrawal
| Measure |
Treatment (Pembrolizumab, Carboplatin)
Patients receive pembrolizumab IV over 30 minutes on day 1 and carboplatin IV over 30-60 minutes on day 1 beginning with course 3. Courses repeat every 21 days for 24 months in the absence of disease progression or unacceptable toxicity.
Carboplatin: Given IV
Laboratory Biomarker Analysis: Correlative studies
Pembrolizumab: Given IV
|
|---|---|
|
Screening - 1st Response Assessment
Disease Progression
|
2
|
|
Screening - 1st Response Assessment
Adverse Event
|
2
|
|
Study Treatment Period: Cycles 4-6
Disease Progression
|
5
|
|
Study Treatment Period: Cycles 7- 9+
Disease Progression
|
1
|
Baseline Characteristics
Pembrolizumab and Carboplatin in Treating Patients With Circulating Tumor Cells Positive Metastatic Breast Cancer
Baseline characteristics by cohort
| Measure |
Treatment (Pembrolizumab, Carboplatin)
n=12 Participants
Patients receive pembrolizumab IV over 30 minutes on day 1 and carboplatin IV over 30-60 minutes on day 1 beginning with course 3. Courses repeat every 21 days for 24 months in the absence of disease progression or unacceptable toxicity.
Carboplatin: Given IV
Laboratory Biomarker Analysis: Correlative studies
Pembrolizumab: Given IV
|
|---|---|
|
Age, Customized
Age · 30-39
|
2 Participants
n=9 Participants
|
|
Age, Customized
Age · 40-49
|
2 Participants
n=9 Participants
|
|
Age, Customized
Age · 50-59
|
3 Participants
n=9 Participants
|
|
Age, Customized
Age · 60-69
|
5 Participants
n=9 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=9 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=9 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=9 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
11 Participants
n=9 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=9 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
White
|
11 Participants
n=9 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=9 Participants
|
PRIMARY outcome
Timeframe: Every 9 weeks from the first study treatment, assessed up to 3 yearsPopulation: Any patient who has completed at least 1 cycles of study treatment are evaluable for this endpoint.
PFS will be based on investigator assessment. PFS will be defined as the time from the first study treatment to the first occurrence of progression or death, and will be assessed every 9 weeks after beginning of treatment.
Outcome measures
| Measure |
Treatment (Pembrolizumab, Carboplatin)
n=9 Participants
Patients receive pembrolizumab IV over 30 minutes on day 1 and carboplatin IV over 30-60 minutes on day 1 beginning with course 3. Courses repeat every 21 days for 24 months in the absence of disease progression or unacceptable toxicity.
Carboplatin: Given IV
Laboratory Biomarker Analysis: Correlative studies
Pembrolizumab: Given IV
|
|---|---|
|
Progression Free Survival (PFS)
|
1.94 Months
Interval 1.68 to 2.04
|
SECONDARY outcome
Timeframe: 4 years and 6 monthsTo evaluate the impact on OS, ORR and CBR with combination Carboplatin - pembrolizumab in patients with CTCs positive MBC who have not received prior chemotherapy for metastatic disease or have developed recurrence after completion of neoadjuvant/adjuvant therapy or are de-novo stage IV. ORR and CBR will be evaluated according to RECIST criteria and in relation to PDL-1 expression in tissue and CTCs.
Outcome measures
| Measure |
Treatment (Pembrolizumab, Carboplatin)
n=10 Participants
Patients receive pembrolizumab IV over 30 minutes on day 1 and carboplatin IV over 30-60 minutes on day 1 beginning with course 3. Courses repeat every 21 days for 24 months in the absence of disease progression or unacceptable toxicity.
Carboplatin: Given IV
Laboratory Biomarker Analysis: Correlative studies
Pembrolizumab: Given IV
|
|---|---|
|
Overall Survival (OS)
|
6.77 Months
Interval 2.99 to
In R "survival" package, the median and its confidence interval are defined by drawing a horizontal line at 0.5 on the plot of the Kaplan-Meier survival curve and its confidence bands. The intersection of the line with the upper CI band defines the upper limit for the median's confidence interval. This is common when small sample size is small resulting in wide confidence intervals, where the upper limit at the end of the study exceeds the median survival time.
|
SECONDARY outcome
Timeframe: Every 9 weeks from the first study treatment, assessed up to 3 yearsTo evaluate the impact on OS, ORR and CBR with combination Carboplatin - pembrolizumab in patients with CTCs positive MBC who have not received prior chemotherapy for metastatic disease or have developed recurrence after completion of neoadjuvant/adjuvant therapy or are de-novo stage IV. ORR and CBR will be evaluated according to RECIST criteria and in relation to PDL-1 expression in tissue and CTCs.
Outcome measures
| Measure |
Treatment (Pembrolizumab, Carboplatin)
n=9 Participants
Patients receive pembrolizumab IV over 30 minutes on day 1 and carboplatin IV over 30-60 minutes on day 1 beginning with course 3. Courses repeat every 21 days for 24 months in the absence of disease progression or unacceptable toxicity.
Carboplatin: Given IV
Laboratory Biomarker Analysis: Correlative studies
Pembrolizumab: Given IV
|
|---|---|
|
Overall Response Rate (ORR)
|
2 Participants
|
SECONDARY outcome
Timeframe: Every 9 weeks from the first study treatment, assessed up to 3 yearsTo evaluate the impact on OS, ORR and CBR with combination Carboplatin - pembrolizumab in patients with CTCs positive MBC who have not received prior chemotherapy for metastatic disease or have developed recurrence after completion of neoadjuvant/adjuvant therapy or are de-novo stage IV. ORR and CBR will be evaluated according to RECIST criteria and in relation to PDL-1 expression in tissue and CTCs.
Outcome measures
| Measure |
Treatment (Pembrolizumab, Carboplatin)
n=9 Participants
Patients receive pembrolizumab IV over 30 minutes on day 1 and carboplatin IV over 30-60 minutes on day 1 beginning with course 3. Courses repeat every 21 days for 24 months in the absence of disease progression or unacceptable toxicity.
Carboplatin: Given IV
Laboratory Biomarker Analysis: Correlative studies
Pembrolizumab: Given IV
|
|---|---|
|
Clinical Benefit Rate (CBR)
|
3 Participants
|
SECONDARY outcome
Timeframe: Every 9 weeks from the first study treatment, assessed up to 3 yearsImmune-related response defined as irPR or irCR and assessed by irRECIST.
Outcome measures
| Measure |
Treatment (Pembrolizumab, Carboplatin)
n=9 Participants
Patients receive pembrolizumab IV over 30 minutes on day 1 and carboplatin IV over 30-60 minutes on day 1 beginning with course 3. Courses repeat every 21 days for 24 months in the absence of disease progression or unacceptable toxicity.
Carboplatin: Given IV
Laboratory Biomarker Analysis: Correlative studies
Pembrolizumab: Given IV
|
|---|---|
|
Immune-related Response
|
2 Participants
|
SECONDARY outcome
Timeframe: Every 9 weeks from the first study treatment, assessed up to 3 yearsImmune-related clinical benefit rate defined as immune-related stable disease (irSD), irPR or irCR and assessed by irRECIST.
Outcome measures
| Measure |
Treatment (Pembrolizumab, Carboplatin)
n=9 Participants
Patients receive pembrolizumab IV over 30 minutes on day 1 and carboplatin IV over 30-60 minutes on day 1 beginning with course 3. Courses repeat every 21 days for 24 months in the absence of disease progression or unacceptable toxicity.
Carboplatin: Given IV
Laboratory Biomarker Analysis: Correlative studies
Pembrolizumab: Given IV
|
|---|---|
|
Immune-related Clinical Benefit Rate
|
3 Participants
|
Adverse Events
Treatment (Pembrolizumab, Carboplatin)
Serious events: 7 serious events
Other events: 12 other events
Deaths: 12 deaths
Serious adverse events
| Measure |
Treatment (Pembrolizumab, Carboplatin)
n=12 participants at risk
Patients receive pembrolizumab IV over 30 minutes on day 1 and carboplatin IV over 30-60 minutes on day 1 beginning with course 3. Courses repeat every 21 days for 24 months in the absence of disease progression or unacceptable toxicity.
Carboplatin: Given IV
Laboratory Biomarker Analysis: Correlative studies
Pembrolizumab: Given IV
|
|---|---|
|
Immune system disorders
Anaphylaxis
|
8.3%
1/12 • Number of events 1 • All-Cause Mortality was assessed for 4 years and 6 months. Serious and Other (Not Including Serious) Adverse Events were monitored for 3 years and 9 months
|
|
Metabolism and nutrition disorders
Anorexia
|
8.3%
1/12 • Number of events 1 • All-Cause Mortality was assessed for 4 years and 6 months. Serious and Other (Not Including Serious) Adverse Events were monitored for 3 years and 9 months
|
|
Eye disorders
Blurred vision
|
8.3%
1/12 • Number of events 1 • All-Cause Mortality was assessed for 4 years and 6 months. Serious and Other (Not Including Serious) Adverse Events were monitored for 3 years and 9 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
8.3%
1/12 • Number of events 1 • All-Cause Mortality was assessed for 4 years and 6 months. Serious and Other (Not Including Serious) Adverse Events were monitored for 3 years and 9 months
|
|
Nervous system disorders
Facial nerve disorder
|
8.3%
1/12 • Number of events 1 • All-Cause Mortality was assessed for 4 years and 6 months. Serious and Other (Not Including Serious) Adverse Events were monitored for 3 years and 9 months
|
|
Hepatobiliary disorders
Immune-mediated Hepatitis
|
8.3%
1/12 • Number of events 1 • All-Cause Mortality was assessed for 4 years and 6 months. Serious and Other (Not Including Serious) Adverse Events were monitored for 3 years and 9 months
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
8.3%
1/12 • Number of events 1 • All-Cause Mortality was assessed for 4 years and 6 months. Serious and Other (Not Including Serious) Adverse Events were monitored for 3 years and 9 months
|
|
Infections and infestations
Lung infection
|
8.3%
1/12 • Number of events 1 • All-Cause Mortality was assessed for 4 years and 6 months. Serious and Other (Not Including Serious) Adverse Events were monitored for 3 years and 9 months
|
|
Gastrointestinal disorders
Nausea
|
8.3%
1/12 • Number of events 1 • All-Cause Mortality was assessed for 4 years and 6 months. Serious and Other (Not Including Serious) Adverse Events were monitored for 3 years and 9 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
disease progression
|
33.3%
4/12 • Number of events 5 • All-Cause Mortality was assessed for 4 years and 6 months. Serious and Other (Not Including Serious) Adverse Events were monitored for 3 years and 9 months
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
16.7%
2/12 • Number of events 2 • All-Cause Mortality was assessed for 4 years and 6 months. Serious and Other (Not Including Serious) Adverse Events were monitored for 3 years and 9 months
|
|
Vascular disorders
Superior vena cava syndrome
|
8.3%
1/12 • Number of events 1 • All-Cause Mortality was assessed for 4 years and 6 months. Serious and Other (Not Including Serious) Adverse Events were monitored for 3 years and 9 months
|
Other adverse events
| Measure |
Treatment (Pembrolizumab, Carboplatin)
n=12 participants at risk
Patients receive pembrolizumab IV over 30 minutes on day 1 and carboplatin IV over 30-60 minutes on day 1 beginning with course 3. Courses repeat every 21 days for 24 months in the absence of disease progression or unacceptable toxicity.
Carboplatin: Given IV
Laboratory Biomarker Analysis: Correlative studies
Pembrolizumab: Given IV
|
|---|---|
|
Gastrointestinal disorders
Constipation
|
25.0%
3/12 • Number of events 3 • All-Cause Mortality was assessed for 4 years and 6 months. Serious and Other (Not Including Serious) Adverse Events were monitored for 3 years and 9 months
|
|
Gastrointestinal disorders
Cough
|
8.3%
1/12 • Number of events 2 • All-Cause Mortality was assessed for 4 years and 6 months. Serious and Other (Not Including Serious) Adverse Events were monitored for 3 years and 9 months
|
|
Gastrointestinal disorders
Diarrhea
|
8.3%
1/12 • Number of events 4 • All-Cause Mortality was assessed for 4 years and 6 months. Serious and Other (Not Including Serious) Adverse Events were monitored for 3 years and 9 months
|
|
Nervous system disorders
Dizziness
|
16.7%
2/12 • Number of events 2 • All-Cause Mortality was assessed for 4 years and 6 months. Serious and Other (Not Including Serious) Adverse Events were monitored for 3 years and 9 months
|
|
Eye disorders
Dry eye
|
16.7%
2/12 • Number of events 2 • All-Cause Mortality was assessed for 4 years and 6 months. Serious and Other (Not Including Serious) Adverse Events were monitored for 3 years and 9 months
|
|
Gastrointestinal disorders
Dry mouth
|
8.3%
1/12 • Number of events 1 • All-Cause Mortality was assessed for 4 years and 6 months. Serious and Other (Not Including Serious) Adverse Events were monitored for 3 years and 9 months
|
|
Investigations
INR increased
|
8.3%
1/12 • Number of events 2 • All-Cause Mortality was assessed for 4 years and 6 months. Serious and Other (Not Including Serious) Adverse Events were monitored for 3 years and 9 months
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
8.3%
1/12 • Number of events 1 • All-Cause Mortality was assessed for 4 years and 6 months. Serious and Other (Not Including Serious) Adverse Events were monitored for 3 years and 9 months
|
|
Nervous system disorders
Dysgeusia
|
8.3%
1/12 • Number of events 1 • All-Cause Mortality was assessed for 4 years and 6 months. Serious and Other (Not Including Serious) Adverse Events were monitored for 3 years and 9 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
16.7%
2/12 • Number of events 2 • All-Cause Mortality was assessed for 4 years and 6 months. Serious and Other (Not Including Serious) Adverse Events were monitored for 3 years and 9 months
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
8.3%
1/12 • Number of events 1 • All-Cause Mortality was assessed for 4 years and 6 months. Serious and Other (Not Including Serious) Adverse Events were monitored for 3 years and 9 months
|
|
General disorders
Fatigue
|
41.7%
5/12 • Number of events 7 • All-Cause Mortality was assessed for 4 years and 6 months. Serious and Other (Not Including Serious) Adverse Events were monitored for 3 years and 9 months
|
|
General disorders
Fever
|
8.3%
1/12 • Number of events 1 • All-Cause Mortality was assessed for 4 years and 6 months. Serious and Other (Not Including Serious) Adverse Events were monitored for 3 years and 9 months
|
|
Vascular disorders
Flushing
|
8.3%
1/12 • Number of events 1 • All-Cause Mortality was assessed for 4 years and 6 months. Serious and Other (Not Including Serious) Adverse Events were monitored for 3 years and 9 months
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
8.3%
1/12 • Number of events 1 • All-Cause Mortality was assessed for 4 years and 6 months. Serious and Other (Not Including Serious) Adverse Events were monitored for 3 years and 9 months
|
|
Nervous system disorders
Headache
|
8.3%
1/12 • Number of events 1 • All-Cause Mortality was assessed for 4 years and 6 months. Serious and Other (Not Including Serious) Adverse Events were monitored for 3 years and 9 months
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
33.3%
4/12 • Number of events 10 • All-Cause Mortality was assessed for 4 years and 6 months. Serious and Other (Not Including Serious) Adverse Events were monitored for 3 years and 9 months
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
8.3%
1/12 • Number of events 2 • All-Cause Mortality was assessed for 4 years and 6 months. Serious and Other (Not Including Serious) Adverse Events were monitored for 3 years and 9 months
|
|
Vascular disorders
Hypertension
|
8.3%
1/12 • Number of events 6 • All-Cause Mortality was assessed for 4 years and 6 months. Serious and Other (Not Including Serious) Adverse Events were monitored for 3 years and 9 months
|
|
Metabolism and nutrition disorders
Hyperuricemia
|
8.3%
1/12 • Number of events 1 • All-Cause Mortality was assessed for 4 years and 6 months. Serious and Other (Not Including Serious) Adverse Events were monitored for 3 years and 9 months
|
|
Psychiatric disorders
Insomnia
|
16.7%
2/12 • Number of events 2 • All-Cause Mortality was assessed for 4 years and 6 months. Serious and Other (Not Including Serious) Adverse Events were monitored for 3 years and 9 months
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
25.0%
3/12 • Number of events 5 • All-Cause Mortality was assessed for 4 years and 6 months. Serious and Other (Not Including Serious) Adverse Events were monitored for 3 years and 9 months
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
16.7%
2/12 • Number of events 3 • All-Cause Mortality was assessed for 4 years and 6 months. Serious and Other (Not Including Serious) Adverse Events were monitored for 3 years and 9 months
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
16.7%
2/12 • Number of events 2 • All-Cause Mortality was assessed for 4 years and 6 months. Serious and Other (Not Including Serious) Adverse Events were monitored for 3 years and 9 months
|
|
Metabolism and nutrition disorders
Hypokalemia
|
41.7%
5/12 • Number of events 6 • All-Cause Mortality was assessed for 4 years and 6 months. Serious and Other (Not Including Serious) Adverse Events were monitored for 3 years and 9 months
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
16.7%
2/12 • Number of events 3 • All-Cause Mortality was assessed for 4 years and 6 months. Serious and Other (Not Including Serious) Adverse Events were monitored for 3 years and 9 months
|
|
Metabolism and nutrition disorders
Hyponatremia
|
8.3%
1/12 • Number of events 1 • All-Cause Mortality was assessed for 4 years and 6 months. Serious and Other (Not Including Serious) Adverse Events were monitored for 3 years and 9 months
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
8.3%
1/12 • Number of events 1 • All-Cause Mortality was assessed for 4 years and 6 months. Serious and Other (Not Including Serious) Adverse Events were monitored for 3 years and 9 months
|
|
Endocrine disorders
Hypothyroidism
|
16.7%
2/12 • Number of events 2 • All-Cause Mortality was assessed for 4 years and 6 months. Serious and Other (Not Including Serious) Adverse Events were monitored for 3 years and 9 months
|
|
General disorders
Infusion related reaction
|
8.3%
1/12 • Number of events 1 • All-Cause Mortality was assessed for 4 years and 6 months. Serious and Other (Not Including Serious) Adverse Events were monitored for 3 years and 9 months
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
8.3%
1/12 • Number of events 1 • All-Cause Mortality was assessed for 4 years and 6 months. Serious and Other (Not Including Serious) Adverse Events were monitored for 3 years and 9 months
|
|
General disorders
Chills
|
8.3%
1/12 • Number of events 1 • All-Cause Mortality was assessed for 4 years and 6 months. Serious and Other (Not Including Serious) Adverse Events were monitored for 3 years and 9 months
|
|
Gastrointestinal disorders
Colitis
|
8.3%
1/12 • Number of events 2 • All-Cause Mortality was assessed for 4 years and 6 months. Serious and Other (Not Including Serious) Adverse Events were monitored for 3 years and 9 months
|
|
Psychiatric disorders
Confusion
|
8.3%
1/12 • Number of events 1 • All-Cause Mortality was assessed for 4 years and 6 months. Serious and Other (Not Including Serious) Adverse Events were monitored for 3 years and 9 months
|
|
Infections and infestations
Conjunctivitis infective
|
8.3%
1/12 • Number of events 1 • All-Cause Mortality was assessed for 4 years and 6 months. Serious and Other (Not Including Serious) Adverse Events were monitored for 3 years and 9 months
|
|
Gastrointestinal disorders
Abdominal Pain
|
8.3%
1/12 • Number of events 1 • All-Cause Mortality was assessed for 4 years and 6 months. Serious and Other (Not Including Serious) Adverse Events were monitored for 3 years and 9 months
|
|
Investigations
Alanine aminotransferase increased
|
33.3%
4/12 • Number of events 6 • All-Cause Mortality was assessed for 4 years and 6 months. Serious and Other (Not Including Serious) Adverse Events were monitored for 3 years and 9 months
|
|
Investigations
Alkaline phosphatase increased
|
41.7%
5/12 • Number of events 9 • All-Cause Mortality was assessed for 4 years and 6 months. Serious and Other (Not Including Serious) Adverse Events were monitored for 3 years and 9 months
|
|
Blood and lymphatic system disorders
Anemia
|
33.3%
4/12 • Number of events 18 • All-Cause Mortality was assessed for 4 years and 6 months. Serious and Other (Not Including Serious) Adverse Events were monitored for 3 years and 9 months
|
|
Metabolism and nutrition disorders
Anorexia
|
33.3%
4/12 • Number of events 4 • All-Cause Mortality was assessed for 4 years and 6 months. Serious and Other (Not Including Serious) Adverse Events were monitored for 3 years and 9 months
|
|
Psychiatric disorders
Anxiety
|
8.3%
1/12 • Number of events 1 • All-Cause Mortality was assessed for 4 years and 6 months. Serious and Other (Not Including Serious) Adverse Events were monitored for 3 years and 9 months
|
|
Investigations
Aspartate aminotransferase increased
|
58.3%
7/12 • Number of events 7 • All-Cause Mortality was assessed for 4 years and 6 months. Serious and Other (Not Including Serious) Adverse Events were monitored for 3 years and 9 months
|
|
Investigations
Blood bilirubin increased
|
16.7%
2/12 • Number of events 3 • All-Cause Mortality was assessed for 4 years and 6 months. Serious and Other (Not Including Serious) Adverse Events were monitored for 3 years and 9 months
|
|
Eye disorders
Blurred vision
|
16.7%
2/12 • Number of events 2 • All-Cause Mortality was assessed for 4 years and 6 months. Serious and Other (Not Including Serious) Adverse Events were monitored for 3 years and 9 months
|
|
Investigations
Lymphocyte count decreased
|
58.3%
7/12 • Number of events 25 • All-Cause Mortality was assessed for 4 years and 6 months. Serious and Other (Not Including Serious) Adverse Events were monitored for 3 years and 9 months
|
|
Gastrointestinal disorders
Nausea
|
25.0%
3/12 • Number of events 3 • All-Cause Mortality was assessed for 4 years and 6 months. Serious and Other (Not Including Serious) Adverse Events were monitored for 3 years and 9 months
|
|
Investigations
Neutrophil count decreased
|
33.3%
4/12 • Number of events 6 • All-Cause Mortality was assessed for 4 years and 6 months. Serious and Other (Not Including Serious) Adverse Events were monitored for 3 years and 9 months
|
|
General disorders
Pain
|
33.3%
4/12 • Number of events 4 • All-Cause Mortality was assessed for 4 years and 6 months. Serious and Other (Not Including Serious) Adverse Events were monitored for 3 years and 9 months
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
16.7%
2/12 • Number of events 2 • All-Cause Mortality was assessed for 4 years and 6 months. Serious and Other (Not Including Serious) Adverse Events were monitored for 3 years and 9 months
|
|
Investigations
Platelet count decreased
|
50.0%
6/12 • Number of events 17 • All-Cause Mortality was assessed for 4 years and 6 months. Serious and Other (Not Including Serious) Adverse Events were monitored for 3 years and 9 months
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
8.3%
1/12 • Number of events 1 • All-Cause Mortality was assessed for 4 years and 6 months. Serious and Other (Not Including Serious) Adverse Events were monitored for 3 years and 9 months
|
|
Cardiac disorders
Sinus tachycardia
|
33.3%
4/12 • Number of events 4 • All-Cause Mortality was assessed for 4 years and 6 months. Serious and Other (Not Including Serious) Adverse Events were monitored for 3 years and 9 months
|
|
Cardiac disorders
Right breast inflammation
|
8.3%
1/12 • Number of events 1 • All-Cause Mortality was assessed for 4 years and 6 months. Serious and Other (Not Including Serious) Adverse Events were monitored for 3 years and 9 months
|
|
Renal and urinary disorders
Urinary frequency
|
16.7%
2/12 • Number of events 2 • All-Cause Mortality was assessed for 4 years and 6 months. Serious and Other (Not Including Serious) Adverse Events were monitored for 3 years and 9 months
|
|
Investigations
Weight loss
|
25.0%
3/12 • Number of events 4 • All-Cause Mortality was assessed for 4 years and 6 months. Serious and Other (Not Including Serious) Adverse Events were monitored for 3 years and 9 months
|
|
Investigations
White blood cell decreased
|
33.3%
4/12 • Number of events 17 • All-Cause Mortality was assessed for 4 years and 6 months. Serious and Other (Not Including Serious) Adverse Events were monitored for 3 years and 9 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place