Trial Outcomes & Findings for Brain Irradiation and Tremelimumab in Metastatic Breast Cancer (NCT NCT02563925)
NCT ID: NCT02563925
Last Updated: 2022-08-03
Results Overview
will be defined as the time from the first dose of tremelimumab until death or progressive disease, as measured by irRC. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
28 participants
Primary outcome timeframe
12 week
Results posted on
2022-08-03
Participant Flow
Participant milestones
| Measure |
Radiation and Tremelimumab
Subjects will get either whole brain radiation treatment (WBRT) or stereotactic radiosurgery (SRS), as per standard of care, with tremelimumab administered every 28 days. Patients, for whom concurrent HER2 directed therapy trastuzumab is indicated, as determined by the treating investigator, will be enrolled in a parallel HER2 directed therapy trastuzumab safety cohort.
|
|---|---|
|
Overall Study
STARTED
|
28
|
|
Overall Study
COMPLETED
|
26
|
|
Overall Study
NOT COMPLETED
|
2
|
Reasons for withdrawal
| Measure |
Radiation and Tremelimumab
Subjects will get either whole brain radiation treatment (WBRT) or stereotactic radiosurgery (SRS), as per standard of care, with tremelimumab administered every 28 days. Patients, for whom concurrent HER2 directed therapy trastuzumab is indicated, as determined by the treating investigator, will be enrolled in a parallel HER2 directed therapy trastuzumab safety cohort.
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
2
|
Baseline Characteristics
Brain Irradiation and Tremelimumab in Metastatic Breast Cancer
Baseline characteristics by cohort
| Measure |
Radiation and Tremelimumab
n=28 Participants
Subjects will get either whole brain radiation treatment (WBRT) or stereotactic radiosurgery (SRS), as per standard of care, with tremelimumab administered every 28 days. Patients, for whom concurrent HER2 directed therapy trastuzumab is indicated, as determined by the treating investigator, will be enrolled in a parallel HER2 directed therapy trastuzumab safety cohort.
|
|---|---|
|
Age, Continuous
|
50 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
28 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
28 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
17 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
28 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 12 weekwill be defined as the time from the first dose of tremelimumab until death or progressive disease, as measured by irRC. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions
Outcome measures
| Measure |
Radiation and Tremelimumab
n=28 Participants
Subjects will get either whole brain radiation treatment (WBRT) or stereotactic radiosurgery (SRS), as per standard of care, with tremelimumab administered every 28 days. Patients, for whom concurrent HER2 directed therapy trastuzumab is indicated, as determined by the treating investigator, will be enrolled in a parallel HER2 directed therapy trastuzumab safety cohort.
|
|---|---|
|
Progression Free Survival (irPFS)
Progressive Disease
|
21 Participants
|
|
Progression Free Survival (irPFS)
Death
|
1 Participants
|
|
Progression Free Survival (irPFS)
Stable Disease
|
3 Participants
|
|
Progression Free Survival (irPFS)
Partial Response
|
1 Participants
|
|
Progression Free Survival (irPFS)
Not Evaluable
|
2 Participants
|
SECONDARY outcome
Timeframe: 1 yearsafety profile assessed with regular physical examination and toxicity assessment using the NCI CTCAE 4.0. Subjects will be followed with regular radiation oncology assessments as per the standard of care.
Outcome measures
| Measure |
Radiation and Tremelimumab
n=28 Participants
Subjects will get either whole brain radiation treatment (WBRT) or stereotactic radiosurgery (SRS), as per standard of care, with tremelimumab administered every 28 days. Patients, for whom concurrent HER2 directed therapy trastuzumab is indicated, as determined by the treating investigator, will be enrolled in a parallel HER2 directed therapy trastuzumab safety cohort.
|
|---|---|
|
Participants Assessed for Toxicity Using the NCI CTCAE 4.0
|
28 Participants
|
Adverse Events
Radiation and Tremelimumab
Serious events: 20 serious events
Other events: 26 other events
Deaths: 27 deaths
Serious adverse events
| Measure |
Radiation and Tremelimumab
n=28 participants at risk
Subjects will get either whole brain radiation treatment (WBRT) or stereotactic radiosurgery (SRS), as per standard of care, with tremelimumab administered every 28 days. Patients, for whom concurrent HER2 directed therapy trastuzumab is indicated, as determined by the treating investigator, will be enrolled in a parallel HER2 directed therapy trastuzumab safety cohort.
|
|---|---|
|
Gastrointestinal disorders
Abdominal Distension
|
3.6%
1/28 • 1 year
|
|
Gastrointestinal disorders
Abdominal Pain
|
10.7%
3/28 • 1 year
|
|
Investigations
Alanine aminotransferase increased
|
3.6%
1/28 • 1 year
|
|
Gastrointestinal disorders
Ascites
|
7.1%
2/28 • 1 year
|
|
Investigations
Aspartate aminotransferase increased
|
7.1%
2/28 • 1 year
|
|
Nervous system disorders
Ataxia
|
3.6%
1/28 • 1 year
|
|
Investigations
Blood bilirubin increased
|
3.6%
1/28 • 1 year
|
|
Reproductive system and breast disorders
Breast pain
|
3.6%
1/28 • 1 year
|
|
Nervous system disorders
Cognitive disturbance
|
3.6%
1/28 • 1 year
|
|
Gastrointestinal disorders
Colitis
|
10.7%
3/28 • 1 year
|
|
Psychiatric disorders
Confusion
|
7.1%
2/28 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
3.6%
1/28 • 1 year
|
|
General disorders
Death NOS
|
3.6%
1/28 • 1 year
|
|
Metabolism and nutrition disorders
Dehydration
|
3.6%
1/28 • 1 year
|
|
Gastrointestinal disorders
Diarrhea
|
14.3%
4/28 • 1 year
|
|
Gastrointestinal disorders
Dysphagia
|
7.1%
2/28 • 1 year
|
|
Nervous system disorders
Dysphasia
|
3.6%
1/28 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
14.3%
4/28 • 1 year
|
|
Gastrointestinal disorders
Esophagitis
|
3.6%
1/28 • 1 year
|
|
Nervous system disorders
Facial nerve disorder
|
3.6%
1/28 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
10.7%
3/28 • 1 year
|
|
Nervous system disorders
Headache
|
3.6%
1/28 • 1 year
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
7.1%
2/28 • 1 year
|
|
Vascular disorders
Hypertension
|
3.6%
1/28 • 1 year
|
|
Metabolism and nutrition disorders
Hyponatremia
|
3.6%
1/28 • 1 year
|
|
Vascular disorders
Hypotension
|
3.6%
1/28 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
10.7%
3/28 • 1 year
|
|
Gastrointestinal disorders
Nausea
|
10.7%
3/28 • 1 year
|
|
General disorders
Neck edema
|
3.6%
1/28 • 1 year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms ben/mal/unk (inc cyst/polyp) Other, spec
|
28.6%
8/28 • 1 year
|
|
Investigations
Neutrophil count decreased
|
3.6%
1/28 • 1 year
|
|
General disorders
Pain
|
3.6%
1/28 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
7.1%
2/28 • 1 year
|
|
Investigations
Platelet count decreased
|
3.6%
1/28 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
3.6%
1/28 • 1 year
|
|
Cardiac disorders
Sinus tachycardia
|
3.6%
1/28 • 1 year
|
|
Nervous system disorders
Somnolence
|
3.6%
1/28 • 1 year
|
|
Infections and infestations
Urinary tract infection
|
3.6%
1/28 • 1 year
|
|
Gastrointestinal disorders
Vomiting
|
7.1%
2/28 • 1 year
|
Other adverse events
| Measure |
Radiation and Tremelimumab
n=28 participants at risk
Subjects will get either whole brain radiation treatment (WBRT) or stereotactic radiosurgery (SRS), as per standard of care, with tremelimumab administered every 28 days. Patients, for whom concurrent HER2 directed therapy trastuzumab is indicated, as determined by the treating investigator, will be enrolled in a parallel HER2 directed therapy trastuzumab safety cohort.
|
|---|---|
|
Metabolism and nutrition disorders
Anorexia
|
50.0%
14/28 • 1 year
|
|
Gastrointestinal disorders
Nausea
|
39.3%
11/28 • 1 year
|
|
General disorders
Fatigue
|
35.7%
10/28 • 1 year
|
|
Investigations
Weight loss
|
35.7%
10/28 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
32.1%
9/28 • 1 year
|
|
Gastrointestinal disorders
Vomiting
|
32.1%
9/28 • 1 year
|
|
Gastrointestinal disorders
Colitis
|
21.4%
6/28 • 1 year
|
|
Gastrointestinal disorders
Diarrhea
|
21.4%
6/28 • 1 year
|
|
Gastrointestinal disorders
Constipation
|
17.9%
5/28 • 1 year
|
|
Nervous system disorders
Headache
|
17.9%
5/28 • 1 year
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
17.9%
5/28 • 1 year
|
|
Nervous system disorders
Dizziness
|
14.3%
4/28 • 1 year
|
|
Gastrointestinal disorders
Dry Mouth
|
14.3%
4/28 • 1 year
|
|
Nervous system disorders
Dysgeusia
|
14.3%
4/28 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
14.3%
4/28 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
14.3%
4/28 • 1 year
|
|
Gastrointestinal disorders
Mucositis oral
|
14.3%
4/28 • 1 year
|
|
Gastrointestinal disorders
Abdominal pain
|
10.7%
3/28 • 1 year
|
|
Investigations
Alkaline phosphatase increased
|
10.7%
3/28 • 1 year
|
|
Nervous system disorders
Ataxia
|
10.7%
3/28 • 1 year
|
|
General disorders
Pain
|
10.7%
3/28 • 1 year
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
10.7%
3/28 • 1 year
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
10.7%
3/28 • 1 year
|
|
Investigations
Alanine aminotransferase increased
|
7.1%
2/28 • 1 year
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
7.1%
2/28 • 1 year
|
|
Blood and lymphatic system disorders
Anemia
|
7.1%
2/28 • 1 year
|
|
Investigations
Aspartate aminotransferase increased
|
7.1%
2/28 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
7.1%
2/28 • 1 year
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
7.1%
2/28 • 1 year
|
|
Gastrointestinal disorders
Dysphagia
|
7.1%
2/28 • 1 year
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
7.1%
2/28 • 1 year
|
|
General disorders
Gen disorders & admin site conditions Other, spec
|
7.1%
2/28 • 1 year
|
|
Endocrine disorders
Hypothyroidism
|
7.1%
2/28 • 1 year
|
|
Investigations
Investigations - Other, specify
|
7.1%
2/28 • 1 year
|
|
General disorders
Malaise
|
7.1%
2/28 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Resp, thoracic & mediastinal disorder Other, spec
|
7.1%
2/28 • 1 year
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
7.1%
2/28 • 1 year
|
Additional Information
Dr. Shanu Modi, MD
Memorial Sloan Kettering Cancer Center
Phone: 646-888-5243
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place