Trial Outcomes & Findings for Toll-like Receptor (TLR) 7 Agonist, Cyclophosphamide, and Radiotherapy for Breast Cancer With Skin Metastases (NCT NCT01421017)
NCT ID: NCT01421017
Last Updated: 2021-11-18
Results Overview
The systemic tumor response refers to the response at the time of best overall response. The response criteria are specially adapted from Response Evaluation Criteria in Solid Tumor for Immunotherapies (Wolchok, et al., 2009).
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
31 participants
Primary outcome timeframe
9 weeks from the start of the treatment of RT
Results posted on
2021-11-18
Participant Flow
Participant milestones
| Measure |
IMQ+RT
This arm has been closed as of 6/4/2014.
* Weeks 1-2: RT given to one metastatic skin site at 6 Gy on days 1, 3, 5, 8 and 10 (M-W-F-M-W)
* Weeks 1-8: day 1-5 of each week: imiquimod 5% cream applied to all skin sites overnight, starting on day 1 after RT, day 6-7 of each week: rest period.
* Week 9: response assessment
Patients may continue to receive additional cycles (same schedule, RT given to a different site), provided that patients wish to continue, are without clinically significant progression and further treatment may be beneficial in the opinion of the investigator.
Radiation
Imiquimod
|
CTX/IMQ/RT
* Week -1 (day-7): cyclophosphamide 200mg/m2 IV as single infusion
* Weeks 1-2: RT given to one metastatic skin site at 6 Gy on days 1, 3, 5, 8 and 10 (M-W-F-M-W)
* Weeks 1-8: day 1-5 of each week: imiquimod 5% cream applied all sites overnight, starting on day 1 after RT, day 6-7 of each week: rest period.
* Week 9: response assessment
Patients may continue to receive additional cycles (same schedule, RT given to a different site), provided that patients wish to continue, are without clinically significant progression and further treatment may be beneficial in the opinion of the investigator.
Radiation
Imiquimod
Cyclophosphamide
|
CTX/RT
For patients with only non-skin metastatic sites
First cycle (Cycle 1):
* Week -1 (day -7): cyclophosphamide 200mg/m2 IV as single infusion
* Weeks 1-2: RT given to one site at 6 Gy on days 1, 3, 5, 8 and 10 (M-W-F-M-W)
* Week 9: response assessment
Patients may continue to receive additional cycles (same schedule, RT given to a different site), provided that patients wish to continue, are without clinically significant progression and further treatment may be beneficial in the opinion of the investigator.
Radiation
Cyclophosphamide
|
|---|---|---|---|
|
Overall Study
STARTED
|
12
|
12
|
7
|
|
Overall Study
COMPLETED
|
10
|
6
|
4
|
|
Overall Study
NOT COMPLETED
|
2
|
6
|
3
|
Reasons for withdrawal
| Measure |
IMQ+RT
This arm has been closed as of 6/4/2014.
* Weeks 1-2: RT given to one metastatic skin site at 6 Gy on days 1, 3, 5, 8 and 10 (M-W-F-M-W)
* Weeks 1-8: day 1-5 of each week: imiquimod 5% cream applied to all skin sites overnight, starting on day 1 after RT, day 6-7 of each week: rest period.
* Week 9: response assessment
Patients may continue to receive additional cycles (same schedule, RT given to a different site), provided that patients wish to continue, are without clinically significant progression and further treatment may be beneficial in the opinion of the investigator.
Radiation
Imiquimod
|
CTX/IMQ/RT
* Week -1 (day-7): cyclophosphamide 200mg/m2 IV as single infusion
* Weeks 1-2: RT given to one metastatic skin site at 6 Gy on days 1, 3, 5, 8 and 10 (M-W-F-M-W)
* Weeks 1-8: day 1-5 of each week: imiquimod 5% cream applied all sites overnight, starting on day 1 after RT, day 6-7 of each week: rest period.
* Week 9: response assessment
Patients may continue to receive additional cycles (same schedule, RT given to a different site), provided that patients wish to continue, are without clinically significant progression and further treatment may be beneficial in the opinion of the investigator.
Radiation
Imiquimod
Cyclophosphamide
|
CTX/RT
For patients with only non-skin metastatic sites
First cycle (Cycle 1):
* Week -1 (day -7): cyclophosphamide 200mg/m2 IV as single infusion
* Weeks 1-2: RT given to one site at 6 Gy on days 1, 3, 5, 8 and 10 (M-W-F-M-W)
* Week 9: response assessment
Patients may continue to receive additional cycles (same schedule, RT given to a different site), provided that patients wish to continue, are without clinically significant progression and further treatment may be beneficial in the opinion of the investigator.
Radiation
Cyclophosphamide
|
|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
2
|
0
|
0
|
|
Overall Study
POD
|
0
|
6
|
3
|
Baseline Characteristics
Toll-like Receptor (TLR) 7 Agonist, Cyclophosphamide, and Radiotherapy for Breast Cancer With Skin Metastases
Baseline characteristics by cohort
| Measure |
IMQ+RT
n=12 Participants
This arm has been closed as of 6/4/2014.
* Weeks 1-2: RT given to one metastatic skin site at 6 Gy on days 1, 3, 5, 8 and 10 (M-W-F-M-W)
* Weeks 1-8: day 1-5 of each week: imiquimod 5% cream applied to all skin sites overnight, starting on day 1 after RT, day 6-7 of each week: rest period.
* Week 9: response assessment
Patients may continue to receive additional cycles (same schedule, RT given to a different site), provided that patients wish to continue, are without clinically significant progression and further treatment may be beneficial in the opinion of the investigator.
Radiation
Imiquimod
|
CTX/IMQ/RT
n=12 Participants
* Week -1 (day-7): cyclophosphamide 200mg/m2 IV as single infusion
* Weeks 1-2: RT given to one metastatic skin site at 6 Gy on days 1, 3, 5, 8 and 10 (M-W-F-M-W)
* Weeks 1-8: day 1-5 of each week: imiquimod 5% cream applied all sites overnight, starting on day 1 after RT, day 6-7 of each week: rest period.
* Week 9: response assessment
Patients may continue to receive additional cycles (same schedule, RT given to a different site), provided that patients wish to continue, are without clinically significant progression and further treatment may be beneficial in the opinion of the investigator.
Radiation
Imiquimod
Cyclophosphamide
|
CTX/RT
n=7 Participants
For patients with only non-skin metastatic sites
First cycle (Cycle 1):
* Week -1 (day -7): cyclophosphamide 200mg/m2 IV as single infusion
* Weeks 1-2: RT given to one site at 6 Gy on days 1, 3, 5, 8 and 10 (M-W-F-M-W)
* Week 9: response assessment
Patients may continue to receive additional cycles (same schedule, RT given to a different site), provided that patients wish to continue, are without clinically significant progression and further treatment may be beneficial in the opinion of the investigator.
Radiation
Cyclophosphamide
|
Total
n=31 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Customized
Mean Age
|
67 years
STANDARD_DEVIATION 6.2 • n=5 Participants
|
51 years
STANDARD_DEVIATION 7.4 • n=7 Participants
|
51 years
STANDARD_DEVIATION 7.1 • n=5 Participants
|
57 years
STANDARD_DEVIATION 6 • n=4 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
30 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
10 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
28 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
6 Participants
n=4 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
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
8 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
17 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
12 participants
n=5 Participants
|
12 participants
n=7 Participants
|
7 participants
n=5 Participants
|
31 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 9 weeks from the start of the treatment of RTThe systemic tumor response refers to the response at the time of best overall response. The response criteria are specially adapted from Response Evaluation Criteria in Solid Tumor for Immunotherapies (Wolchok, et al., 2009).
Outcome measures
| Measure |
IMQ+RT
n=12 Participants
This arm has been closed as of 6/4/2014.
* Weeks 1-2: RT given to one metastatic skin site at 6 Gy on days 1, 3, 5, 8 and 10 (M-W-F-M-W)
* Weeks 1-8: day 1-5 of each week: imiquimod 5% cream applied to all skin sites overnight, starting on day 1 after RT, day 6-7 of each week: rest period.
* Week 9: response assessment
Patients may continue to receive additional cycles (same schedule, RT given to a different site), provided that patients wish to continue, are without clinically significant progression and further treatment may be beneficial in the opinion of the investigator.
Radiation
Imiquimod
|
CTX/IMQ/RT
n=12 Participants
* Week -1 (day-7): cyclophosphamide 200mg/m2 IV as single infusion
* Weeks 1-2: RT given to one metastatic skin site at 6 Gy on days 1, 3, 5, 8 and 10 (M-W-F-M-W)
* Weeks 1-8: day 1-5 of each week: imiquimod 5% cream applied all sites overnight, starting on day 1 after RT, day 6-7 of each week: rest period.
* Week 9: response assessment
Patients may continue to receive additional cycles (same schedule, RT given to a different site), provided that patients wish to continue, are without clinically significant progression and further treatment may be beneficial in the opinion of the investigator.
Radiation
Imiquimod
Cyclophosphamide
|
CTX/RT
n=7 Participants
For patients with only non-skin metastatic sites
First cycle (Cycle 1):
* Week -1 (day -7): cyclophosphamide 200mg/m2 IV as single infusion
* Weeks 1-2: RT given to one site at 6 Gy on days 1, 3, 5, 8 and 10 (M-W-F-M-W)
* Week 9: response assessment
Patients may continue to receive additional cycles (same schedule, RT given to a different site), provided that patients wish to continue, are without clinically significant progression and further treatment may be beneficial in the opinion of the investigator.
Radiation
Cyclophosphamide
|
|---|---|---|---|
|
Systemic Tumor Response Rates (Complete Response+Partial Response)
|
.25 proportion of tumors
Interval 0.06 to 0.57
|
.083 proportion of tumors
Interval 0.002 to 0.38
|
0 proportion of tumors
Interval 0.0 to 0.0
|
SECONDARY outcome
Timeframe: 9 weeks from the start of the treatmentPopulation: Arm "CTX/RT" is not applicable, as it includes only patients with non-skin metastatic sites.
The response refers to the best overall response, based on European Organization for Research and Treatment of Cancer's definitions for chest wall tumors (Kouloulias, et al., 2002).
Outcome measures
| Measure |
IMQ+RT
n=12 Participants
This arm has been closed as of 6/4/2014.
* Weeks 1-2: RT given to one metastatic skin site at 6 Gy on days 1, 3, 5, 8 and 10 (M-W-F-M-W)
* Weeks 1-8: day 1-5 of each week: imiquimod 5% cream applied to all skin sites overnight, starting on day 1 after RT, day 6-7 of each week: rest period.
* Week 9: response assessment
Patients may continue to receive additional cycles (same schedule, RT given to a different site), provided that patients wish to continue, are without clinically significant progression and further treatment may be beneficial in the opinion of the investigator.
Radiation
Imiquimod
|
CTX/IMQ/RT
n=12 Participants
* Week -1 (day-7): cyclophosphamide 200mg/m2 IV as single infusion
* Weeks 1-2: RT given to one metastatic skin site at 6 Gy on days 1, 3, 5, 8 and 10 (M-W-F-M-W)
* Weeks 1-8: day 1-5 of each week: imiquimod 5% cream applied all sites overnight, starting on day 1 after RT, day 6-7 of each week: rest period.
* Week 9: response assessment
Patients may continue to receive additional cycles (same schedule, RT given to a different site), provided that patients wish to continue, are without clinically significant progression and further treatment may be beneficial in the opinion of the investigator.
Radiation
Imiquimod
Cyclophosphamide
|
CTX/RT
For patients with only non-skin metastatic sites
First cycle (Cycle 1):
* Week -1 (day -7): cyclophosphamide 200mg/m2 IV as single infusion
* Weeks 1-2: RT given to one site at 6 Gy on days 1, 3, 5, 8 and 10 (M-W-F-M-W)
* Week 9: response assessment
Patients may continue to receive additional cycles (same schedule, RT given to a different site), provided that patients wish to continue, are without clinically significant progression and further treatment may be beneficial in the opinion of the investigator.
Radiation
Cyclophosphamide
|
|---|---|---|---|
|
Local Skin Tumor Response Rates (Complete Response + Partial Response)
Local Area A; irradiated area
|
0.83 proportion of tumors
Interval 0.52 to 0.98
|
0.75 proportion of tumors
Interval 0.43 to 0.95
|
—
|
|
Local Skin Tumor Response Rates (Complete Response + Partial Response)
Local Area B; non-irradiated area
|
.33 proportion of tumors
Interval 0.1 to 0.65
|
.083 proportion of tumors
Interval 0.002 to 0.38
|
—
|
Adverse Events
IMQ+RT
Serious events: 2 serious events
Other events: 12 other events
Deaths: 0 deaths
CTX/IMQ/RT
Serious events: 3 serious events
Other events: 12 other events
Deaths: 0 deaths
CTX/RT
Serious events: 1 serious events
Other events: 7 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
IMQ+RT
n=12 participants at risk
This arm has been closed as of 6/4/2014.
Weeks 1-2: RT given to one metastatic skin site at 6 Gy on days 1, 3, 5, 8 and 10 (M-W-F-M-W) Weeks 1-8: day 1-5 of each week: imiquimod 5% cream applied to all skin sites overnight, starting on day 1 after RT, day 6-7 of each week: rest period.
Week 9: response assessment
Patients may continue to receive additional cycles (same schedule, RT given to a different site), provided that patients wish to continue, are without clinically significant progression and further treatment may be beneficial in the opinion of the investigator.
Radiation Imiquimod
|
CTX/IMQ/RT
n=12 participants at risk
Week -1 (day-7): cyclophosphamide 200mg/m2 IV as single infusion Weeks 1-2: RT given to one metastatic skin site at 6 Gy on days 1, 3, 5, 8 and 10 (M-W-F-M-W) Weeks 1-8: day 1-5 of each week: imiquimod 5% cream applied all sites overnight, starting on day 1 after RT, day 6-7 of each week: rest period.
Week 9: response assessment
Patients may continue to receive additional cycles (same schedule, RT given to a different site), provided that patients wish to continue, are without clinically significant progression and further treatment may be beneficial in the opinion of the investigator.
Radiation Imiquimod Cyclophosphamide
|
CTX/RT
n=7 participants at risk
For patients with only non-skin metastatic sites
First cycle (Cycle 1):
Week -1 (day -7): cyclophosphamide 200mg/m2 IV as single infusion Weeks 1-2: RT given to one site at 6 Gy on days 1, 3, 5, 8 and 10 (M-W-F-M-W) Week 9: response assessment
Patients may continue to receive additional cycles (same schedule, RT given to a different site), provided that patients wish to continue, are without clinically significant progression and further treatment may be beneficial in the opinion of the investigator.
Radiation Cyclophosphamide
|
|---|---|---|---|
|
Infections and infestations
Breast Infection
|
8.3%
1/12 • 8 weeks
|
0.00%
0/12 • 8 weeks
|
0.00%
0/7 • 8 weeks
|
|
General disorders
Breast Pain
|
8.3%
1/12 • 8 weeks
|
0.00%
0/12 • 8 weeks
|
0.00%
0/7 • 8 weeks
|
|
General disorders
Fever
|
8.3%
1/12 • 8 weeks
|
0.00%
0/12 • 8 weeks
|
0.00%
0/7 • 8 weeks
|
|
Infections and infestations
Skin Infection
|
8.3%
1/12 • 8 weeks
|
8.3%
1/12 • 8 weeks
|
0.00%
0/7 • 8 weeks
|
|
Skin and subcutaneous tissue disorders
Skin ulceration
|
8.3%
1/12 • 8 weeks
|
0.00%
0/12 • 8 weeks
|
0.00%
0/7 • 8 weeks
|
|
General disorders
Tumor Pain
|
16.7%
2/12 • 8 weeks
|
0.00%
0/12 • 8 weeks
|
0.00%
0/7 • 8 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neosplasms Benign
|
8.3%
1/12 • 8 weeks
|
0.00%
0/12 • 8 weeks
|
0.00%
0/7 • 8 weeks
|
|
Eye disorders
Blurred Vision
|
0.00%
0/12 • 8 weeks
|
0.00%
0/12 • 8 weeks
|
14.3%
1/7 • 8 weeks
|
|
Nervous system disorders
Dysarthria
|
0.00%
0/12 • 8 weeks
|
8.3%
1/12 • 8 weeks
|
0.00%
0/7 • 8 weeks
|
|
General disorders
Headache
|
0.00%
0/12 • 8 weeks
|
8.3%
1/12 • 8 weeks
|
0.00%
0/7 • 8 weeks
|
|
General disorders
Pain in extremity
|
0.00%
0/12 • 8 weeks
|
8.3%
1/12 • 8 weeks
|
0.00%
0/7 • 8 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
0.00%
0/12 • 8 weeks
|
8.3%
1/12 • 8 weeks
|
0.00%
0/7 • 8 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Adult respiratory disorder
|
0.00%
0/12 • 8 weeks
|
8.3%
1/12 • 8 weeks
|
0.00%
0/7 • 8 weeks
|
Other adverse events
| Measure |
IMQ+RT
n=12 participants at risk
This arm has been closed as of 6/4/2014.
Weeks 1-2: RT given to one metastatic skin site at 6 Gy on days 1, 3, 5, 8 and 10 (M-W-F-M-W) Weeks 1-8: day 1-5 of each week: imiquimod 5% cream applied to all skin sites overnight, starting on day 1 after RT, day 6-7 of each week: rest period.
Week 9: response assessment
Patients may continue to receive additional cycles (same schedule, RT given to a different site), provided that patients wish to continue, are without clinically significant progression and further treatment may be beneficial in the opinion of the investigator.
Radiation Imiquimod
|
CTX/IMQ/RT
n=12 participants at risk
Week -1 (day-7): cyclophosphamide 200mg/m2 IV as single infusion Weeks 1-2: RT given to one metastatic skin site at 6 Gy on days 1, 3, 5, 8 and 10 (M-W-F-M-W) Weeks 1-8: day 1-5 of each week: imiquimod 5% cream applied all sites overnight, starting on day 1 after RT, day 6-7 of each week: rest period.
Week 9: response assessment
Patients may continue to receive additional cycles (same schedule, RT given to a different site), provided that patients wish to continue, are without clinically significant progression and further treatment may be beneficial in the opinion of the investigator.
Radiation Imiquimod Cyclophosphamide
|
CTX/RT
n=7 participants at risk
For patients with only non-skin metastatic sites
First cycle (Cycle 1):
Week -1 (day -7): cyclophosphamide 200mg/m2 IV as single infusion Weeks 1-2: RT given to one site at 6 Gy on days 1, 3, 5, 8 and 10 (M-W-F-M-W) Week 9: response assessment
Patients may continue to receive additional cycles (same schedule, RT given to a different site), provided that patients wish to continue, are without clinically significant progression and further treatment may be beneficial in the opinion of the investigator.
Radiation Cyclophosphamide
|
|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Adult respiratory distress syndrome
|
0.00%
0/12 • 8 weeks
|
100.0%
12/12 • 8 weeks
|
0.00%
0/7 • 8 weeks
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/12 • 8 weeks
|
100.0%
12/12 • 8 weeks
|
0.00%
0/7 • 8 weeks
|
|
Blood and lymphatic system disorders
Anemia
|
100.0%
12/12 • 8 weeks
|
100.0%
12/12 • 8 weeks
|
100.0%
7/7 • 8 weeks
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/12 • 8 weeks
|
100.0%
12/12 • 8 weeks
|
0.00%
0/7 • 8 weeks
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
100.0%
12/12 • 8 weeks
|
100.0%
12/12 • 8 weeks
|
0.00%
0/7 • 8 weeks
|
|
General disorders
Back Pain
|
0.00%
0/12 • 8 weeks
|
100.0%
12/12 • 8 weeks
|
0.00%
0/7 • 8 weeks
|
|
General disorders
Breast Pain
|
100.0%
12/12 • 8 weeks
|
100.0%
12/12 • 8 weeks
|
0.00%
0/7 • 8 weeks
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/12 • 8 weeks
|
100.0%
12/12 • 8 weeks
|
100.0%
7/7 • 8 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/12 • 8 weeks
|
100.0%
12/12 • 8 weeks
|
100.0%
7/7 • 8 weeks
|
|
Psychiatric disorders
Depression
|
0.00%
0/12 • 8 weeks
|
100.0%
12/12 • 8 weeks
|
0.00%
0/7 • 8 weeks
|
|
Skin and subcutaneous tissue disorders
Dermatitis Radiation
|
100.0%
12/12 • 8 weeks
|
100.0%
12/12 • 8 weeks
|
0.00%
0/7 • 8 weeks
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/12 • 8 weeks
|
100.0%
12/12 • 8 weeks
|
100.0%
7/7 • 8 weeks
|
|
Musculoskeletal and connective tissue disorders
Dysarthria
|
0.00%
0/12 • 8 weeks
|
100.0%
12/12 • 8 weeks
|
0.00%
0/7 • 8 weeks
|
|
General disorders
Fatigue
|
100.0%
12/12 • 8 weeks
|
100.0%
12/12 • 8 weeks
|
100.0%
7/7 • 8 weeks
|
|
General disorders
Headache
|
0.00%
0/12 • 8 weeks
|
100.0%
12/12 • 8 weeks
|
0.00%
0/7 • 8 weeks
|
|
Blood and lymphatic system disorders
Lymphedema
|
0.00%
0/12 • 8 weeks
|
100.0%
12/12 • 8 weeks
|
0.00%
0/7 • 8 weeks
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
100.0%
12/12 • 8 weeks
|
100.0%
12/12 • 8 weeks
|
0.00%
0/7 • 8 weeks
|
|
General disorders
Nausea
|
100.0%
12/12 • 8 weeks
|
100.0%
12/12 • 8 weeks
|
100.0%
7/7 • 8 weeks
|
|
General disorders
Pain
|
100.0%
12/12 • 8 weeks
|
100.0%
12/12 • 8 weeks
|
0.00%
0/7 • 8 weeks
|
|
Musculoskeletal and connective tissue disorders
Paresthesia
|
0.00%
0/12 • 8 weeks
|
100.0%
12/12 • 8 weeks
|
100.0%
7/7 • 8 weeks
|
|
Gastrointestinal disorders
Abdominal Distension
|
100.0%
12/12 • 8 weeks
|
0.00%
0/12 • 8 weeks
|
100.0%
7/7 • 8 weeks
|
|
Gastrointestinal disorders
Alkaline Phosphatase Increased
|
0.00%
0/12 • 8 weeks
|
0.00%
0/12 • 8 weeks
|
100.0%
7/7 • 8 weeks
|
|
Gastrointestinal disorders
Aspartate Aminotransferase Increased
|
0.00%
0/12 • 8 weeks
|
0.00%
0/12 • 8 weeks
|
100.0%
7/7 • 8 weeks
|
|
Blood and lymphatic system disorders
Blood bilirubin increased
|
0.00%
0/12 • 8 weeks
|
0.00%
0/12 • 8 weeks
|
100.0%
7/7 • 8 weeks
|
|
Eye disorders
Blurred Vision
|
0.00%
0/12 • 8 weeks
|
0.00%
0/12 • 8 weeks
|
100.0%
7/7 • 8 weeks
|
|
Metabolism and nutrition disorders
Anorexia
|
100.0%
12/12 • 8 weeks
|
0.00%
0/12 • 8 weeks
|
0.00%
0/7 • 8 weeks
|
|
General disorders
Body Odor
|
100.0%
12/12 • 8 weeks
|
0.00%
0/12 • 8 weeks
|
0.00%
0/7 • 8 weeks
|
|
Infections and infestations
Breast Infection
|
100.0%
12/12 • 8 weeks
|
0.00%
0/12 • 8 weeks
|
0.00%
0/7 • 8 weeks
|
|
General disorders
Dehydration
|
100.0%
12/12 • 8 weeks
|
0.00%
0/12 • 8 weeks
|
0.00%
0/7 • 8 weeks
|
|
Skin and subcutaneous tissue disorders
Erythema Multiforma
|
100.0%
12/12 • 8 weeks
|
0.00%
0/12 • 8 weeks
|
0.00%
0/7 • 8 weeks
|
|
General disorders
Fever
|
100.0%
12/12 • 8 weeks
|
0.00%
0/12 • 8 weeks
|
100.0%
7/7 • 8 weeks
|
|
Immune system disorders
Febrile Neutropenia
|
100.0%
12/12 • 8 weeks
|
0.00%
0/12 • 8 weeks
|
0.00%
0/7 • 8 weeks
|
|
General disorders
Insomnia
|
100.0%
12/12 • 8 weeks
|
0.00%
0/12 • 8 weeks
|
0.00%
0/7 • 8 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, malignant, and unspecified
|
100.0%
12/12 • 8 weeks
|
0.00%
0/12 • 8 weeks
|
0.00%
0/7 • 8 weeks
|
|
Skin and subcutaneous tissue disorders
Pruitus
|
100.0%
12/12 • 8 weeks
|
0.00%
0/12 • 8 weeks
|
0.00%
0/7 • 8 weeks
|
|
Metabolism and nutrition disorders
Weight Loss
|
100.0%
12/12 • 8 weeks
|
0.00%
0/12 • 8 weeks
|
100.0%
7/7 • 8 weeks
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/12 • 8 weeks
|
0.00%
0/12 • 8 weeks
|
100.0%
7/7 • 8 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place