Trial Outcomes & Findings for Phase II Trial of EVEROLIMUS ± Trastuzumab in Hormone-Refractory Metastatic Breast Cancer (NCT NCT00912340)
NCT ID: NCT00912340
Last Updated: 2018-12-05
Results Overview
Median PFS will be calculated based on time to first progression or death.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
70 participants
Primary outcome timeframe
Every 3 to 4 weeks after study start, until progression or death, assessed up to 5 years
Results posted on
2018-12-05
Participant Flow
Patients were recruited at Winship Cancer Institute of Emory University, Emory University Hospital Midtown, and Robert H. Lurie Comprehensive Cancer Center of Northwestern University.
70 participants were enrolled. Nine were found to be ineligible. Three declined to participate and were not treated.
Participant milestones
| Measure |
Trastuzumab
Patients receive trastuzumab IV over 30 minutes once every 3 weeks and continue to receive their most recent hormone therapy. Patients achieving disease progression receive everolimus PO daily in combination with trastuzumab and hormone therapy.
|
Everolimus
Patients receive everolimus PO daily and continue their most recent hormone therapy. Patients achieving disease progression receive trastuzumab IV over 30-90 minutes once every 3 weeks in combination with everolimus and hormone therapy.
|
Trastuzumab and Everolimus (ARM REMOVED)
Patients receive trastuzumab IV over 30 minutes once every 3 weeks and everolimus PO daily while continuing to receive their most recent hormone therapy.
|
|---|---|---|---|
|
Overall Study
STARTED
|
24
|
30
|
4
|
|
Overall Study
COMPLETED
|
22
|
26
|
0
|
|
Overall Study
NOT COMPLETED
|
2
|
4
|
4
|
Reasons for withdrawal
| Measure |
Trastuzumab
Patients receive trastuzumab IV over 30 minutes once every 3 weeks and continue to receive their most recent hormone therapy. Patients achieving disease progression receive everolimus PO daily in combination with trastuzumab and hormone therapy.
|
Everolimus
Patients receive everolimus PO daily and continue their most recent hormone therapy. Patients achieving disease progression receive trastuzumab IV over 30-90 minutes once every 3 weeks in combination with everolimus and hormone therapy.
|
Trastuzumab and Everolimus (ARM REMOVED)
Patients receive trastuzumab IV over 30 minutes once every 3 weeks and everolimus PO daily while continuing to receive their most recent hormone therapy.
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
2
|
4
|
0
|
|
Overall Study
Protocol revised to remove arm
|
0
|
0
|
4
|
Baseline Characteristics
Phase II Trial of EVEROLIMUS ± Trastuzumab in Hormone-Refractory Metastatic Breast Cancer
Baseline characteristics by cohort
| Measure |
Trastuzumab
n=24 Participants
Patients receive trastuzumab IV over 30 minutes once every 3 weeks and continue to receive their most recent hormone therapy. Patients achieving disease progression receive everolimus PO daily in combination with trastuzumab and hormone therapy.
|
Everolimus
n=30 Participants
Patients receive everolimus PO daily and continue their most recent hormone therapy. Patients achieving disease progression receive trastuzumab IV over 30-90 minutes once every 3 weeks in combination with everolimus and hormone therapy.
|
Trastuzumab and Everolimus (ARM REMOVED)
n=4 Participants
Patients receive trastuzumab IV over 30 minutes once every 3 weeks and everolimus PO daily while continuing to receive their most recent hormone therapy.
|
Total
n=58 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Customized
Age range 30-39
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Age, Customized
Age range 40-49
|
2 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
|
Age, Customized
Age range 50-59
|
9 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
17 Participants
n=4 Participants
|
|
Age, Customized
Age range 60-69
|
4 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
17 Participants
n=4 Participants
|
|
Age, Customized
Age range 70-79
|
7 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
14 Participants
n=4 Participants
|
|
Age, Customized
Age range 81-89
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Sex: Female, Male
Female
|
23 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
57 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
23 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
53 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
4 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
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 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
|
9 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
13 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
15 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
41 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
|
0 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
24 participants
n=5 Participants
|
30 participants
n=7 Participants
|
4 participants
n=5 Participants
|
0 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Every 3 to 4 weeks after study start, until progression or death, assessed up to 5 yearsPopulation: Four patients were treated with both trastuzumab \& everolimus up front. These patients were not included in the data analysis because this arm was later discontinued.
Median PFS will be calculated based on time to first progression or death.
Outcome measures
| Measure |
Trastuzumab
n=24 Participants
Patients receive trastuzumab IV over 30 minutes once every 3 weeks and continue to receive their most recent hormone therapy. Patients achieving disease progression receive everolimus PO daily in combination with trastuzumab and hormone therapy.
|
Everolimus
n=30 Participants
Patients receive everolimus PO daily and continue their most recent hormone therapy. Patients achieving disease progression receive trastuzumab IV over 30-90 minutes once every 3 weeks in combination with everolimus and hormone therapy.
|
Trastuzumab and Everolimus (ARM REMOVED)
Patients receive trastuzumab IV over 30 minutes once every 3 weeks and everolimus PO daily while continuing to receive their most recent hormone therapy.
|
|---|---|---|---|
|
Progression-free Survival (PFS) Until First Progression
|
2.0 months
Interval 1.6 to 4.1
|
5.7 months
Interval 3.9 to 8.9
|
—
|
SECONDARY outcome
Timeframe: Every 3 to 4 weeks after study start, until progression or death, assessed up to 5 yearsPopulation: Among 48 patients with disease progression, everolimus was added to 16 patients treated by trastuzumab, and trastuzumab was added to 12 patients treated by everolimus. Four patients were treated with both trastuzumab \& everolimus up front. These patients were not included in the data analysis because this arm was later discontinued.
Median PFS will be calculated based on time to first progression or death.
Outcome measures
| Measure |
Trastuzumab
n=16 Participants
Patients receive trastuzumab IV over 30 minutes once every 3 weeks and continue to receive their most recent hormone therapy. Patients achieving disease progression receive everolimus PO daily in combination with trastuzumab and hormone therapy.
|
Everolimus
n=12 Participants
Patients receive everolimus PO daily and continue their most recent hormone therapy. Patients achieving disease progression receive trastuzumab IV over 30-90 minutes once every 3 weeks in combination with everolimus and hormone therapy.
|
Trastuzumab and Everolimus (ARM REMOVED)
Patients receive trastuzumab IV over 30 minutes once every 3 weeks and everolimus PO daily while continuing to receive their most recent hormone therapy.
|
|---|---|---|---|
|
Progression-free Survival (PFS) in Patients Who Crossed Over
|
6.3 months
Interval 2.6 to 10.5
|
3.1 months
Interval 1.8 to 6.7
|
—
|
Adverse Events
Trastuzumab
Serious events: 1 serious events
Other events: 0 other events
Deaths: 9 deaths
Everolimus
Serious events: 6 serious events
Other events: 12 other events
Deaths: 8 deaths
Trastuzumab and Everolimus (ARM REMOVED)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 3 deaths
Serious adverse events
| Measure |
Trastuzumab
n=24 participants at risk
Patients receive 10 mg everolimus PO daily and continue to receive their most recent hormone therapy. Patients achieving disease progression receive 8 mg/kg trastuzumab IV over 30-90 minutes once every 3 weeks in combination with everolimus and hormone therapy.
|
Everolimus
n=30 participants at risk
Patients receive everolimus PO daily and continue their most recent hormone therapy. Patients achieving disease progression receive trastuzumab IV over 30-90 minutes once every 3 weeks in combination with everolimus and hormone therapy.
|
Trastuzumab and Everolimus (ARM REMOVED)
n=4 participants at risk
Patients receive trastuzumab IV over 30 minutes once every 3 weeks and everolimus PO daily while continuing to receive their most recent hormone therapy.
|
|---|---|---|---|
|
Cardiac disorders
Pericardial effusion
|
4.2%
1/24 • Adverse events were collected throughout the study assessed up to 5 years. Patients were evaluated in the clinic every 3 weeks and then after a protocol amendment, they were evaluated every 4 weeks if only receiving everolimus plus endocrine therapy and not trastuzumab. Scans were done at 6 weeks from the start of treatment and then every 12 weeks.
|
3.3%
1/30 • Adverse events were collected throughout the study assessed up to 5 years. Patients were evaluated in the clinic every 3 weeks and then after a protocol amendment, they were evaluated every 4 weeks if only receiving everolimus plus endocrine therapy and not trastuzumab. Scans were done at 6 weeks from the start of treatment and then every 12 weeks.
|
0.00%
0/4 • Adverse events were collected throughout the study assessed up to 5 years. Patients were evaluated in the clinic every 3 weeks and then after a protocol amendment, they were evaluated every 4 weeks if only receiving everolimus plus endocrine therapy and not trastuzumab. Scans were done at 6 weeks from the start of treatment and then every 12 weeks.
|
|
Cardiac disorders
Other cardiac disorder
|
0.00%
0/24 • Adverse events were collected throughout the study assessed up to 5 years. Patients were evaluated in the clinic every 3 weeks and then after a protocol amendment, they were evaluated every 4 weeks if only receiving everolimus plus endocrine therapy and not trastuzumab. Scans were done at 6 weeks from the start of treatment and then every 12 weeks.
|
3.3%
1/30 • Adverse events were collected throughout the study assessed up to 5 years. Patients were evaluated in the clinic every 3 weeks and then after a protocol amendment, they were evaluated every 4 weeks if only receiving everolimus plus endocrine therapy and not trastuzumab. Scans were done at 6 weeks from the start of treatment and then every 12 weeks.
|
0.00%
0/4 • Adverse events were collected throughout the study assessed up to 5 years. Patients were evaluated in the clinic every 3 weeks and then after a protocol amendment, they were evaluated every 4 weeks if only receiving everolimus plus endocrine therapy and not trastuzumab. Scans were done at 6 weeks from the start of treatment and then every 12 weeks.
|
|
Cardiac disorders
Ejection fraction decrease
|
0.00%
0/24 • Adverse events were collected throughout the study assessed up to 5 years. Patients were evaluated in the clinic every 3 weeks and then after a protocol amendment, they were evaluated every 4 weeks if only receiving everolimus plus endocrine therapy and not trastuzumab. Scans were done at 6 weeks from the start of treatment and then every 12 weeks.
|
3.3%
1/30 • Adverse events were collected throughout the study assessed up to 5 years. Patients were evaluated in the clinic every 3 weeks and then after a protocol amendment, they were evaluated every 4 weeks if only receiving everolimus plus endocrine therapy and not trastuzumab. Scans were done at 6 weeks from the start of treatment and then every 12 weeks.
|
0.00%
0/4 • Adverse events were collected throughout the study assessed up to 5 years. Patients were evaluated in the clinic every 3 weeks and then after a protocol amendment, they were evaluated every 4 weeks if only receiving everolimus plus endocrine therapy and not trastuzumab. Scans were done at 6 weeks from the start of treatment and then every 12 weeks.
|
|
General disorders
Hypertension
|
0.00%
0/24 • Adverse events were collected throughout the study assessed up to 5 years. Patients were evaluated in the clinic every 3 weeks and then after a protocol amendment, they were evaluated every 4 weeks if only receiving everolimus plus endocrine therapy and not trastuzumab. Scans were done at 6 weeks from the start of treatment and then every 12 weeks.
|
3.3%
1/30 • Adverse events were collected throughout the study assessed up to 5 years. Patients were evaluated in the clinic every 3 weeks and then after a protocol amendment, they were evaluated every 4 weeks if only receiving everolimus plus endocrine therapy and not trastuzumab. Scans were done at 6 weeks from the start of treatment and then every 12 weeks.
|
0.00%
0/4 • Adverse events were collected throughout the study assessed up to 5 years. Patients were evaluated in the clinic every 3 weeks and then after a protocol amendment, they were evaluated every 4 weeks if only receiving everolimus plus endocrine therapy and not trastuzumab. Scans were done at 6 weeks from the start of treatment and then every 12 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/24 • Adverse events were collected throughout the study assessed up to 5 years. Patients were evaluated in the clinic every 3 weeks and then after a protocol amendment, they were evaluated every 4 weeks if only receiving everolimus plus endocrine therapy and not trastuzumab. Scans were done at 6 weeks from the start of treatment and then every 12 weeks.
|
6.7%
2/30 • Adverse events were collected throughout the study assessed up to 5 years. Patients were evaluated in the clinic every 3 weeks and then after a protocol amendment, they were evaluated every 4 weeks if only receiving everolimus plus endocrine therapy and not trastuzumab. Scans were done at 6 weeks from the start of treatment and then every 12 weeks.
|
0.00%
0/4 • Adverse events were collected throughout the study assessed up to 5 years. Patients were evaluated in the clinic every 3 weeks and then after a protocol amendment, they were evaluated every 4 weeks if only receiving everolimus plus endocrine therapy and not trastuzumab. Scans were done at 6 weeks from the start of treatment and then every 12 weeks.
|
|
Infections and infestations
Salivary gland infection
|
0.00%
0/24 • Adverse events were collected throughout the study assessed up to 5 years. Patients were evaluated in the clinic every 3 weeks and then after a protocol amendment, they were evaluated every 4 weeks if only receiving everolimus plus endocrine therapy and not trastuzumab. Scans were done at 6 weeks from the start of treatment and then every 12 weeks.
|
3.3%
1/30 • Adverse events were collected throughout the study assessed up to 5 years. Patients were evaluated in the clinic every 3 weeks and then after a protocol amendment, they were evaluated every 4 weeks if only receiving everolimus plus endocrine therapy and not trastuzumab. Scans were done at 6 weeks from the start of treatment and then every 12 weeks.
|
0.00%
0/4 • Adverse events were collected throughout the study assessed up to 5 years. Patients were evaluated in the clinic every 3 weeks and then after a protocol amendment, they were evaluated every 4 weeks if only receiving everolimus plus endocrine therapy and not trastuzumab. Scans were done at 6 weeks from the start of treatment and then every 12 weeks.
|
Other adverse events
| Measure |
Trastuzumab
n=24 participants at risk
Patients receive 10 mg everolimus PO daily and continue to receive their most recent hormone therapy. Patients achieving disease progression receive 8 mg/kg trastuzumab IV over 30-90 minutes once every 3 weeks in combination with everolimus and hormone therapy.
|
Everolimus
n=30 participants at risk
Patients receive everolimus PO daily and continue their most recent hormone therapy. Patients achieving disease progression receive trastuzumab IV over 30-90 minutes once every 3 weeks in combination with everolimus and hormone therapy.
|
Trastuzumab and Everolimus (ARM REMOVED)
n=4 participants at risk
Patients receive trastuzumab IV over 30 minutes once every 3 weeks and everolimus PO daily while continuing to receive their most recent hormone therapy.
|
|---|---|---|---|
|
Investigations
Aspartate aminotransferase (AST) increased
|
0.00%
0/24 • Adverse events were collected throughout the study assessed up to 5 years. Patients were evaluated in the clinic every 3 weeks and then after a protocol amendment, they were evaluated every 4 weeks if only receiving everolimus plus endocrine therapy and not trastuzumab. Scans were done at 6 weeks from the start of treatment and then every 12 weeks.
|
3.3%
1/30 • Adverse events were collected throughout the study assessed up to 5 years. Patients were evaluated in the clinic every 3 weeks and then after a protocol amendment, they were evaluated every 4 weeks if only receiving everolimus plus endocrine therapy and not trastuzumab. Scans were done at 6 weeks from the start of treatment and then every 12 weeks.
|
0.00%
0/4 • Adverse events were collected throughout the study assessed up to 5 years. Patients were evaluated in the clinic every 3 weeks and then after a protocol amendment, they were evaluated every 4 weeks if only receiving everolimus plus endocrine therapy and not trastuzumab. Scans were done at 6 weeks from the start of treatment and then every 12 weeks.
|
|
Investigations
Alanine aminotransferase (ALT) increased
|
0.00%
0/24 • Adverse events were collected throughout the study assessed up to 5 years. Patients were evaluated in the clinic every 3 weeks and then after a protocol amendment, they were evaluated every 4 weeks if only receiving everolimus plus endocrine therapy and not trastuzumab. Scans were done at 6 weeks from the start of treatment and then every 12 weeks.
|
3.3%
1/30 • Adverse events were collected throughout the study assessed up to 5 years. Patients were evaluated in the clinic every 3 weeks and then after a protocol amendment, they were evaluated every 4 weeks if only receiving everolimus plus endocrine therapy and not trastuzumab. Scans were done at 6 weeks from the start of treatment and then every 12 weeks.
|
0.00%
0/4 • Adverse events were collected throughout the study assessed up to 5 years. Patients were evaluated in the clinic every 3 weeks and then after a protocol amendment, they were evaluated every 4 weeks if only receiving everolimus plus endocrine therapy and not trastuzumab. Scans were done at 6 weeks from the start of treatment and then every 12 weeks.
|
|
Investigations
Creatinine increased
|
0.00%
0/24 • Adverse events were collected throughout the study assessed up to 5 years. Patients were evaluated in the clinic every 3 weeks and then after a protocol amendment, they were evaluated every 4 weeks if only receiving everolimus plus endocrine therapy and not trastuzumab. Scans were done at 6 weeks from the start of treatment and then every 12 weeks.
|
3.3%
1/30 • Adverse events were collected throughout the study assessed up to 5 years. Patients were evaluated in the clinic every 3 weeks and then after a protocol amendment, they were evaluated every 4 weeks if only receiving everolimus plus endocrine therapy and not trastuzumab. Scans were done at 6 weeks from the start of treatment and then every 12 weeks.
|
0.00%
0/4 • Adverse events were collected throughout the study assessed up to 5 years. Patients were evaluated in the clinic every 3 weeks and then after a protocol amendment, they were evaluated every 4 weeks if only receiving everolimus plus endocrine therapy and not trastuzumab. Scans were done at 6 weeks from the start of treatment and then every 12 weeks.
|
|
Gastrointestinal disorders
Mucositis oral
|
0.00%
0/24 • Adverse events were collected throughout the study assessed up to 5 years. Patients were evaluated in the clinic every 3 weeks and then after a protocol amendment, they were evaluated every 4 weeks if only receiving everolimus plus endocrine therapy and not trastuzumab. Scans were done at 6 weeks from the start of treatment and then every 12 weeks.
|
6.7%
2/30 • Adverse events were collected throughout the study assessed up to 5 years. Patients were evaluated in the clinic every 3 weeks and then after a protocol amendment, they were evaluated every 4 weeks if only receiving everolimus plus endocrine therapy and not trastuzumab. Scans were done at 6 weeks from the start of treatment and then every 12 weeks.
|
0.00%
0/4 • Adverse events were collected throughout the study assessed up to 5 years. Patients were evaluated in the clinic every 3 weeks and then after a protocol amendment, they were evaluated every 4 weeks if only receiving everolimus plus endocrine therapy and not trastuzumab. Scans were done at 6 weeks from the start of treatment and then every 12 weeks.
|
|
General disorders
Fatigue
|
0.00%
0/24 • Adverse events were collected throughout the study assessed up to 5 years. Patients were evaluated in the clinic every 3 weeks and then after a protocol amendment, they were evaluated every 4 weeks if only receiving everolimus plus endocrine therapy and not trastuzumab. Scans were done at 6 weeks from the start of treatment and then every 12 weeks.
|
6.7%
2/30 • Adverse events were collected throughout the study assessed up to 5 years. Patients were evaluated in the clinic every 3 weeks and then after a protocol amendment, they were evaluated every 4 weeks if only receiving everolimus plus endocrine therapy and not trastuzumab. Scans were done at 6 weeks from the start of treatment and then every 12 weeks.
|
0.00%
0/4 • Adverse events were collected throughout the study assessed up to 5 years. Patients were evaluated in the clinic every 3 weeks and then after a protocol amendment, they were evaluated every 4 weeks if only receiving everolimus plus endocrine therapy and not trastuzumab. Scans were done at 6 weeks from the start of treatment and then every 12 weeks.
|
|
General disorders
Edema limbs
|
0.00%
0/24 • Adverse events were collected throughout the study assessed up to 5 years. Patients were evaluated in the clinic every 3 weeks and then after a protocol amendment, they were evaluated every 4 weeks if only receiving everolimus plus endocrine therapy and not trastuzumab. Scans were done at 6 weeks from the start of treatment and then every 12 weeks.
|
3.3%
1/30 • Adverse events were collected throughout the study assessed up to 5 years. Patients were evaluated in the clinic every 3 weeks and then after a protocol amendment, they were evaluated every 4 weeks if only receiving everolimus plus endocrine therapy and not trastuzumab. Scans were done at 6 weeks from the start of treatment and then every 12 weeks.
|
0.00%
0/4 • Adverse events were collected throughout the study assessed up to 5 years. Patients were evaluated in the clinic every 3 weeks and then after a protocol amendment, they were evaluated every 4 weeks if only receiving everolimus plus endocrine therapy and not trastuzumab. Scans were done at 6 weeks from the start of treatment and then every 12 weeks.
|
|
Metabolism and nutrition disorders
Hypertriglyceridemia
|
0.00%
0/24 • Adverse events were collected throughout the study assessed up to 5 years. Patients were evaluated in the clinic every 3 weeks and then after a protocol amendment, they were evaluated every 4 weeks if only receiving everolimus plus endocrine therapy and not trastuzumab. Scans were done at 6 weeks from the start of treatment and then every 12 weeks.
|
6.7%
2/30 • Adverse events were collected throughout the study assessed up to 5 years. Patients were evaluated in the clinic every 3 weeks and then after a protocol amendment, they were evaluated every 4 weeks if only receiving everolimus plus endocrine therapy and not trastuzumab. Scans were done at 6 weeks from the start of treatment and then every 12 weeks.
|
0.00%
0/4 • Adverse events were collected throughout the study assessed up to 5 years. Patients were evaluated in the clinic every 3 weeks and then after a protocol amendment, they were evaluated every 4 weeks if only receiving everolimus plus endocrine therapy and not trastuzumab. Scans were done at 6 weeks from the start of treatment and then every 12 weeks.
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/24 • Adverse events were collected throughout the study assessed up to 5 years. Patients were evaluated in the clinic every 3 weeks and then after a protocol amendment, they were evaluated every 4 weeks if only receiving everolimus plus endocrine therapy and not trastuzumab. Scans were done at 6 weeks from the start of treatment and then every 12 weeks.
|
3.3%
1/30 • Adverse events were collected throughout the study assessed up to 5 years. Patients were evaluated in the clinic every 3 weeks and then after a protocol amendment, they were evaluated every 4 weeks if only receiving everolimus plus endocrine therapy and not trastuzumab. Scans were done at 6 weeks from the start of treatment and then every 12 weeks.
|
0.00%
0/4 • Adverse events were collected throughout the study assessed up to 5 years. Patients were evaluated in the clinic every 3 weeks and then after a protocol amendment, they were evaluated every 4 weeks if only receiving everolimus plus endocrine therapy and not trastuzumab. Scans were done at 6 weeks from the start of treatment and then every 12 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/24 • Adverse events were collected throughout the study assessed up to 5 years. Patients were evaluated in the clinic every 3 weeks and then after a protocol amendment, they were evaluated every 4 weeks if only receiving everolimus plus endocrine therapy and not trastuzumab. Scans were done at 6 weeks from the start of treatment and then every 12 weeks.
|
3.3%
1/30 • Adverse events were collected throughout the study assessed up to 5 years. Patients were evaluated in the clinic every 3 weeks and then after a protocol amendment, they were evaluated every 4 weeks if only receiving everolimus plus endocrine therapy and not trastuzumab. Scans were done at 6 weeks from the start of treatment and then every 12 weeks.
|
0.00%
0/4 • Adverse events were collected throughout the study assessed up to 5 years. Patients were evaluated in the clinic every 3 weeks and then after a protocol amendment, they were evaluated every 4 weeks if only receiving everolimus plus endocrine therapy and not trastuzumab. Scans were done at 6 weeks from the start of treatment and then every 12 weeks.
|
|
Investigations
Decreased ejection fraction
|
0.00%
0/24 • Adverse events were collected throughout the study assessed up to 5 years. Patients were evaluated in the clinic every 3 weeks and then after a protocol amendment, they were evaluated every 4 weeks if only receiving everolimus plus endocrine therapy and not trastuzumab. Scans were done at 6 weeks from the start of treatment and then every 12 weeks.
|
6.7%
2/30 • Adverse events were collected throughout the study assessed up to 5 years. Patients were evaluated in the clinic every 3 weeks and then after a protocol amendment, they were evaluated every 4 weeks if only receiving everolimus plus endocrine therapy and not trastuzumab. Scans were done at 6 weeks from the start of treatment and then every 12 weeks.
|
0.00%
0/4 • Adverse events were collected throughout the study assessed up to 5 years. Patients were evaluated in the clinic every 3 weeks and then after a protocol amendment, they were evaluated every 4 weeks if only receiving everolimus plus endocrine therapy and not trastuzumab. Scans were done at 6 weeks from the start of treatment and then every 12 weeks.
|
|
General disorders
Angioedema
|
0.00%
0/24 • Adverse events were collected throughout the study assessed up to 5 years. Patients were evaluated in the clinic every 3 weeks and then after a protocol amendment, they were evaluated every 4 weeks if only receiving everolimus plus endocrine therapy and not trastuzumab. Scans were done at 6 weeks from the start of treatment and then every 12 weeks.
|
3.3%
1/30 • Adverse events were collected throughout the study assessed up to 5 years. Patients were evaluated in the clinic every 3 weeks and then after a protocol amendment, they were evaluated every 4 weeks if only receiving everolimus plus endocrine therapy and not trastuzumab. Scans were done at 6 weeks from the start of treatment and then every 12 weeks.
|
0.00%
0/4 • Adverse events were collected throughout the study assessed up to 5 years. Patients were evaluated in the clinic every 3 weeks and then after a protocol amendment, they were evaluated every 4 weeks if only receiving everolimus plus endocrine therapy and not trastuzumab. Scans were done at 6 weeks from the start of treatment and then every 12 weeks.
|
|
Vascular disorders
Hypertension
|
0.00%
0/24 • Adverse events were collected throughout the study assessed up to 5 years. Patients were evaluated in the clinic every 3 weeks and then after a protocol amendment, they were evaluated every 4 weeks if only receiving everolimus plus endocrine therapy and not trastuzumab. Scans were done at 6 weeks from the start of treatment and then every 12 weeks.
|
6.7%
2/30 • Adverse events were collected throughout the study assessed up to 5 years. Patients were evaluated in the clinic every 3 weeks and then after a protocol amendment, they were evaluated every 4 weeks if only receiving everolimus plus endocrine therapy and not trastuzumab. Scans were done at 6 weeks from the start of treatment and then every 12 weeks.
|
0.00%
0/4 • Adverse events were collected throughout the study assessed up to 5 years. Patients were evaluated in the clinic every 3 weeks and then after a protocol amendment, they were evaluated every 4 weeks if only receiving everolimus plus endocrine therapy and not trastuzumab. Scans were done at 6 weeks from the start of treatment and then every 12 weeks.
|
Additional Information
Elisavet Paplomata, Principal Investigator
Emory University
Phone: 404-778-1900
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place