Trial Outcomes & Findings for T-DM1 and Non-pegylated Liposomal Doxorubicin in Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Metastatic Breast Cancer (NCT NCT02562378)
NCT ID: NCT02562378
Last Updated: 2022-02-23
Results Overview
Treatment-related adverse events (AEs) of any grade reported in ≥10% of patients.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
15 participants
Primary outcome timeframe
Baseline up to 6 weeks after patient entry (Cycle2Day21)
Results posted on
2022-02-23
Participant Flow
Participant milestones
| Measure |
Period 1: Cohort 1, Trastuzumab + Doxorubicin (45 mg/m2)
Trastuzumab emtansine (T-DM1) will be administered at a fixed dose of 3.6 mg/kg IV on Day 1 every 3 weeks and non-pegylated liposomal doxorubicin at a dose level of 45 mg/m2.
|
Period 2: Cohort 2, Trastuzumab + Doxorubicin (50 mg/m2)
Trastuzumab emtansine (T-DM1) will be administered at a fixed dose of 3.6 mg/kg IV on Day 1 every 3 weeks and non-pegylated liposomal doxorubicin at a dose level of 50 mg/m2.
|
Period 3: Cohort 3, Trastuzumab + Doxorubicin (60 mg/m2)
Trastuzumab emtansine (T-DM1) will be administered at a fixed dose of 3.6 mg/kg IV on Day 1 every 3 weeks and non-pegylated liposomal doxorubicin at a dose level of 60 mg/m2.
|
|---|---|---|---|
|
Overall Study
STARTED
|
3
|
3
|
9
|
|
Overall Study
COMPLETED
|
3
|
3
|
9
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
T-DM1 and Non-pegylated Liposomal Doxorubicin in Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Metastatic Breast Cancer
Baseline characteristics by cohort
| Measure |
Cohort 1, Trastuzumab + Doxorubicin (45 mg/m2)
n=3 Participants
Trastuzumab and non-pegylated liposomal doxorubicin: Trastuzumab 3.6 mg/kg IV on Day 1 every 3 weeks and non-pegylated liposomal doxorubicin (45 mg/m2) IV
|
Cohort 2, Trastuzumab + Doxorubicin (50 mg/m2)
n=3 Participants
Trastuzumab and non-pegylated liposomal doxorubicin: Trastuzumab 3.6 mg/kg IV on Day 1 every 3 weeks and non-pegylated liposomal doxorubicin (50 mg/m2) IV
|
Cohort 3, Trastuzumab + Doxorubicin (60 mg/m2)
n=9 Participants
Trastuzumab and non-pegylated liposomal doxorubicin: Trastuzumab 3.6 mg/kg IV on Day 1 every 3 weeks and non-pegylated liposomal doxorubicin (60 mg/m2) IV
|
Total
n=15 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
50.3 years
STANDARD_DEVIATION 11.5 • n=99 Participants
|
58.7 years
STANDARD_DEVIATION 2.1 • n=107 Participants
|
45.9 years
STANDARD_DEVIATION 12.5 • n=206 Participants
|
49.3 years
STANDARD_DEVIATION 11.6 • n=157 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
9 Participants
n=206 Participants
|
15 Participants
n=157 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=157 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=157 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
3 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
9 Participants
n=206 Participants
|
15 Participants
n=157 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=157 Participants
|
|
Region of Enrollment
France
|
0 participants
n=99 Participants
|
1 participants
n=107 Participants
|
2 participants
n=206 Participants
|
3 participants
n=157 Participants
|
|
Region of Enrollment
Spain
|
3 participants
n=99 Participants
|
2 participants
n=107 Participants
|
5 participants
n=206 Participants
|
10 participants
n=157 Participants
|
|
Region of Enrollment
Slovenia
|
0 participants
n=99 Participants
|
0 participants
n=107 Participants
|
2 participants
n=206 Participants
|
2 participants
n=157 Participants
|
|
ECOG Performance Status (ITT)
ECOG score 0 (Fully active)
|
3 participants
n=99 Participants
|
3 participants
n=107 Participants
|
7 participants
n=206 Participants
|
13 participants
n=157 Participants
|
|
ECOG Performance Status (ITT)
ECOG score 1 (Restricted physical activity)
|
0 participants
n=99 Participants
|
0 participants
n=107 Participants
|
2 participants
n=206 Participants
|
2 participants
n=157 Participants
|
|
Prior Medication
No
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
5 Participants
n=157 Participants
|
|
Prior Medication
Yes
|
3 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
10 Participants
n=157 Participants
|
|
Estrogen Receptor (ER) (ITT)
Positive
|
2 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
11 Participants
n=157 Participants
|
|
Estrogen Receptor (ER) (ITT)
Negative
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
4 Participants
n=157 Participants
|
|
Progesterone Receptor (PgR) (ITT)
Positive
|
1 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
7 Participants
n=157 Participants
|
|
Progesterone Receptor (PgR) (ITT)
Negative
|
2 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
8 Participants
n=157 Participants
|
|
Human Epidermal Growth Factor Receptor 2 (HER2) (ITT)
|
3 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
9 Participants
n=206 Participants
|
15 Participants
n=157 Participants
|
|
HER2 detection method
Immunohistochemistry (IHC)
|
2 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
11 Participants
n=157 Participants
|
|
HER2 detection method
Fluorescence in situ hybridization (FISH)
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
3 Participants
n=157 Participants
|
|
HER2 detection method
Chromogenic in situ hybridization (CISH)
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
1 Participants
n=157 Participants
|
|
TNM Staging (ITT)
Core biopsy
|
3 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
13 Participants
n=157 Participants
|
|
TNM Staging (ITT)
Fine needle aspiration
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
1 Participants
n=157 Participants
|
|
TNM Staging (ITT)
Missing
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
1 Participants
n=157 Participants
|
|
TNM Staging T Category
Tx
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
2 Participants
n=157 Participants
|
|
TNM Staging T Category
T1
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
4 Participants
n=157 Participants
|
|
TNM Staging T Category
T2
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
2 Participants
n=157 Participants
|
|
TNM Staging T Category
T3
|
2 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
5 Participants
n=157 Participants
|
|
TNM Staging T Category
T4
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
2 Participants
n=157 Participants
|
|
TNM Staging N Category
Nx
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
2 Participants
n=157 Participants
|
|
TNM Staging N Category
N0
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
2 Participants
n=157 Participants
|
|
TNM Staging N Category
N1
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
6 Participants
n=157 Participants
|
|
TNM Staging N Category
N2
|
3 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
5 Participants
n=157 Participants
|
|
TNM Staging M Category
Mx
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
2 Participants
n=157 Participants
|
|
TNM Staging M Category
M0
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
4 Participants
n=157 Participants
|
|
TNM Staging M Category
M1
|
3 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
9 Participants
n=157 Participants
|
|
Disease Stage at Initial Diagnostic
I
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
1 Participants
n=157 Participants
|
|
Disease Stage at Initial Diagnostic
II
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
2 Participants
n=157 Participants
|
|
Disease Stage at Initial Diagnostic
III
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
3 Participants
n=157 Participants
|
|
Disease Stage at Initial Diagnostic
IV
|
3 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
9 Participants
n=157 Participants
|
|
Metastasis sites (ITT)
Metastasis
|
3 participants
n=99 Participants
|
3 participants
n=107 Participants
|
9 participants
n=206 Participants
|
15 participants
n=157 Participants
|
|
Metastasis sites (ITT)
Lymph node
|
2 participants
n=99 Participants
|
1 participants
n=107 Participants
|
7 participants
n=206 Participants
|
10 participants
n=157 Participants
|
|
Metastasis sites (ITT)
Bone
|
3 participants
n=99 Participants
|
3 participants
n=107 Participants
|
4 participants
n=206 Participants
|
10 participants
n=157 Participants
|
|
Metastasis sites (ITT)
Liver
|
0 participants
n=99 Participants
|
2 participants
n=107 Participants
|
4 participants
n=206 Participants
|
6 participants
n=157 Participants
|
|
Metastasis sites (ITT)
Lung
|
0 participants
n=99 Participants
|
1 participants
n=107 Participants
|
4 participants
n=206 Participants
|
5 participants
n=157 Participants
|
|
Metastasis sites (ITT)
Brain
|
1 participants
n=99 Participants
|
0 participants
n=107 Participants
|
1 participants
n=206 Participants
|
2 participants
n=157 Participants
|
|
Metastasis sites (ITT)
Skin
|
0 participants
n=99 Participants
|
0 participants
n=107 Participants
|
2 participants
n=206 Participants
|
2 participants
n=157 Participants
|
|
Metastasis sites (ITT)
Other sites
|
0 participants
n=99 Participants
|
1 participants
n=107 Participants
|
1 participants
n=206 Participants
|
2 participants
n=157 Participants
|
|
Previous Treatment for Metastatic Breast Cancer
1
|
0 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
11 Participants
n=157 Participants
|
|
Previous Treatment for Metastatic Breast Cancer
2
|
3 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
3 Participants
n=157 Participants
|
|
Previous Treatment for Metastatic Breast Cancer
3
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
1 Participants
n=157 Participants
|
PRIMARY outcome
Timeframe: Baseline up to 6 weeks after patient entry (Cycle2Day21)Treatment-related adverse events (AEs) of any grade reported in ≥10% of patients.
Outcome measures
| Measure |
Cohort 1, Trastuzumab + Doxorubicin (45 mg/m2)
n=3 Participants
Trastuzumab and non-pegylated liposomal doxorubicin: Trastuzumab 3.6 mg/kg IV on Day 1 every 3 weeks and non-pegylated liposomal doxorubicin (45 mg/m2) IV
|
Cohort 2, Trastuzumab + Doxorubicin (50 mg/m2)
n=3 Participants
Trastuzumab and non-pegylated liposomal doxorubicin: Trastuzumab 3.6 mg/kg IV on Day 1 every 3 weeks and non-pegylated liposomal doxorubicin (50 mg/m2) IV
|
Cohort 3, Trastuzumab + Doxorubicin (60 mg/m2)
n=9 Participants
Trastuzumab and non-pegylated liposomal doxorubicin: Trastuzumab 3.6 mg/kg IV on Day 1 every 3 weeks and non-pegylated liposomal doxorubicin (60 mg/m2) IV
|
|---|---|---|---|
|
Hematological - Dose Limiting Toxicities
Neutropenia
|
1 participants
|
3 participants
|
7 participants
|
|
Hematological - Dose Limiting Toxicities
Thrombopenia
|
1 participants
|
2 participants
|
6 participants
|
|
Hematological - Dose Limiting Toxicities
Anemia
|
1 participants
|
1 participants
|
4 participants
|
|
Hematological - Dose Limiting Toxicities
Leukopenia
|
0 participants
|
1 participants
|
2 participants
|
|
Hematological - Dose Limiting Toxicities
Lymphopenia
|
0 participants
|
1 participants
|
2 participants
|
|
Hematological - Dose Limiting Toxicities
Decreased hemoglobin
|
1 participants
|
1 participants
|
0 participants
|
|
Hematological - Dose Limiting Toxicities
Decreased lymphocyte count
|
0 participants
|
1 participants
|
1 participants
|
PRIMARY outcome
Timeframe: Baseline up to 6 weeks after patient entry (Cycle2Day21)Treatment-related AEs of any grade reported in ≥10% of patients.
Outcome measures
| Measure |
Cohort 1, Trastuzumab + Doxorubicin (45 mg/m2)
n=3 Participants
Trastuzumab and non-pegylated liposomal doxorubicin: Trastuzumab 3.6 mg/kg IV on Day 1 every 3 weeks and non-pegylated liposomal doxorubicin (45 mg/m2) IV
|
Cohort 2, Trastuzumab + Doxorubicin (50 mg/m2)
n=3 Participants
Trastuzumab and non-pegylated liposomal doxorubicin: Trastuzumab 3.6 mg/kg IV on Day 1 every 3 weeks and non-pegylated liposomal doxorubicin (50 mg/m2) IV
|
Cohort 3, Trastuzumab + Doxorubicin (60 mg/m2)
n=9 Participants
Trastuzumab and non-pegylated liposomal doxorubicin: Trastuzumab 3.6 mg/kg IV on Day 1 every 3 weeks and non-pegylated liposomal doxorubicin (60 mg/m2) IV
|
|---|---|---|---|
|
Non-Hematological - Dose Limiting Toxicities
Nausea
|
2 participants
|
3 participants
|
4 participants
|
|
Non-Hematological - Dose Limiting Toxicities
Inc. aspartate aminotransferase
|
1 participants
|
1 participants
|
6 participants
|
|
Non-Hematological - Dose Limiting Toxicities
Asthenia
|
3 participants
|
2 participants
|
4 participants
|
|
Non-Hematological - Dose Limiting Toxicities
Inc. alanine aminotransferase
|
1 participants
|
1 participants
|
4 participants
|
|
Non-Hematological - Dose Limiting Toxicities
Inc. brain natriuretic peptide
|
0 participants
|
2 participants
|
4 participants
|
|
Non-Hematological - Dose Limiting Toxicities
Inc. gamma-glutamyl transferasehemoglobin
|
2 participants
|
2 participants
|
2 participants
|
|
Non-Hematological - Dose Limiting Toxicities
Increased troponin Ilymphocyte count
|
0 participants
|
1 participants
|
4 participants
|
|
Non-Hematological - Dose Limiting Toxicities
Decreased appetite
|
1 participants
|
1 participants
|
3 participants
|
|
Non-Hematological - Dose Limiting Toxicities
Alopecia
|
0 participants
|
1 participants
|
3 participants
|
|
Non-Hematological - Dose Limiting Toxicities
Epistaxis
|
0 participants
|
1 participants
|
2 participants
|
|
Non-Hematological - Dose Limiting Toxicities
Rhinorrhea
|
0 participants
|
1 participants
|
2 participants
|
|
Non-Hematological - Dose Limiting Toxicities
Headache
|
0 participants
|
2 participants
|
0 participants
|
|
Non-Hematological - Dose Limiting Toxicities
Fatigue
|
0 participants
|
0 participants
|
2 participants
|
|
Non-Hematological - Dose Limiting Toxicities
Mucosal inflammation
|
0 participants
|
0 participants
|
2 participants
|
|
Non-Hematological - Dose Limiting Toxicities
Inc. blood alkaline phosphatase
|
0 participants
|
1 participants
|
1 participants
|
|
Non-Hematological - Dose Limiting Toxicities
Aphthous ulcer
|
0 participants
|
1 participants
|
1 participants
|
|
Non-Hematological - Dose Limiting Toxicities
Constipation
|
1 participants
|
0 participants
|
1 participants
|
|
Non-Hematological - Dose Limiting Toxicities
Diarrhea
|
1 participants
|
0 participants
|
1 participants
|
|
Non-Hematological - Dose Limiting Toxicities
Dry mouth
|
0 participants
|
1 participants
|
1 participants
|
|
Non-Hematological - Dose Limiting Toxicities
Gingival bleeding
|
0 participants
|
0 participants
|
2 participants
|
|
Non-Hematological - Dose Limiting Toxicities
Vomiting
|
0 participants
|
1 participants
|
1 participants
|
|
Non-Hematological - Dose Limiting Toxicities
Hypoalbuminemia
|
0 participants
|
1 participants
|
1 participants
|
|
Non-Hematological - Dose Limiting Toxicities
Rash
|
0 participants
|
1 participants
|
1 participants
|
SECONDARY outcome
Timeframe: Baseline up to 24 months after patient entryPopulation: Best Overall Response (percentage of participants) with confirmed complete response (CR) or partial response (PR) based on local investigator's assessment according to RECIST v1.1 criteria guidelines
Patients with best overall response of confirmed complete response (CR) or partial response (PR) based on local investigator's assessment according to RECIST criteria guidelines (version 1.1) for target lesions and assessed by CT or MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR
Outcome measures
| Measure |
Cohort 1, Trastuzumab + Doxorubicin (45 mg/m2)
n=3 Participants
Trastuzumab and non-pegylated liposomal doxorubicin: Trastuzumab 3.6 mg/kg IV on Day 1 every 3 weeks and non-pegylated liposomal doxorubicin (45 mg/m2) IV
|
Cohort 2, Trastuzumab + Doxorubicin (50 mg/m2)
n=3 Participants
Trastuzumab and non-pegylated liposomal doxorubicin: Trastuzumab 3.6 mg/kg IV on Day 1 every 3 weeks and non-pegylated liposomal doxorubicin (50 mg/m2) IV
|
Cohort 3, Trastuzumab + Doxorubicin (60 mg/m2)
n=9 Participants
Trastuzumab and non-pegylated liposomal doxorubicin: Trastuzumab 3.6 mg/kg IV on Day 1 every 3 weeks and non-pegylated liposomal doxorubicin (60 mg/m2) IV
|
|---|---|---|---|
|
Overall Response Rate
|
33.3 percentage of participants
Interval 0.8 to 90.6
|
66.7 percentage of participants
Interval 9.4 to 99.2
|
33.3 percentage of participants
Interval 7.5 to 70.1
|
SECONDARY outcome
Timeframe: Baseline up to 24 months after patient entryPopulation: Best Overall Response, n (%)
Patients with best overall response of confirmed complete response (CR) or partial response (PR) based on local investigator's assessment according to RECIST criteria guidelines (version 1.1)
Outcome measures
| Measure |
Cohort 1, Trastuzumab + Doxorubicin (45 mg/m2)
n=3 Participants
Trastuzumab and non-pegylated liposomal doxorubicin: Trastuzumab 3.6 mg/kg IV on Day 1 every 3 weeks and non-pegylated liposomal doxorubicin (45 mg/m2) IV
|
Cohort 2, Trastuzumab + Doxorubicin (50 mg/m2)
n=3 Participants
Trastuzumab and non-pegylated liposomal doxorubicin: Trastuzumab 3.6 mg/kg IV on Day 1 every 3 weeks and non-pegylated liposomal doxorubicin (50 mg/m2) IV
|
Cohort 3, Trastuzumab + Doxorubicin (60 mg/m2)
n=9 Participants
Trastuzumab and non-pegylated liposomal doxorubicin: Trastuzumab 3.6 mg/kg IV on Day 1 every 3 weeks and non-pegylated liposomal doxorubicin (60 mg/m2) IV
|
|---|---|---|---|
|
Best Overall Response
Partial response
|
1 Participants
|
2 Participants
|
3 Participants
|
|
Best Overall Response
Stable disease ≥24 weeks
|
1 Participants
|
0 Participants
|
3 Participants
|
|
Best Overall Response
Stable disease <24 weeks
|
0 Participants
|
1 Participants
|
2 Participants
|
|
Best Overall Response
Progressive disease
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Best Overall Response
Not evaluable
|
0 Participants
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Baseline up to 24 months after patient entryClinical benefit rate (CBR) is defined as the proportion of patients with a best overall response of complete response (CR) or partial response (PR) or stable disease (SD) lasting more than 24 weeks based on local investigator's assessment
Outcome measures
| Measure |
Cohort 1, Trastuzumab + Doxorubicin (45 mg/m2)
n=3 Participants
Trastuzumab and non-pegylated liposomal doxorubicin: Trastuzumab 3.6 mg/kg IV on Day 1 every 3 weeks and non-pegylated liposomal doxorubicin (45 mg/m2) IV
|
Cohort 2, Trastuzumab + Doxorubicin (50 mg/m2)
n=3 Participants
Trastuzumab and non-pegylated liposomal doxorubicin: Trastuzumab 3.6 mg/kg IV on Day 1 every 3 weeks and non-pegylated liposomal doxorubicin (50 mg/m2) IV
|
Cohort 3, Trastuzumab + Doxorubicin (60 mg/m2)
n=9 Participants
Trastuzumab and non-pegylated liposomal doxorubicin: Trastuzumab 3.6 mg/kg IV on Day 1 every 3 weeks and non-pegylated liposomal doxorubicin (60 mg/m2) IV
|
|---|---|---|---|
|
Clinical Benefit Rate
|
66.7 percentage of participants
Interval 9.4 to 99.2
|
66.7 percentage of participants
Interval 9.4 to 99.2
|
66.7 percentage of participants
Interval 38.4 to 88.2
|
SECONDARY outcome
Timeframe: Baseline up to 24 months after patient entryPatients with progression. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, or measurable increase in a non-target lesion, or the appearance of new lesions
Outcome measures
| Measure |
Cohort 1, Trastuzumab + Doxorubicin (45 mg/m2)
n=3 Participants
Trastuzumab and non-pegylated liposomal doxorubicin: Trastuzumab 3.6 mg/kg IV on Day 1 every 3 weeks and non-pegylated liposomal doxorubicin (45 mg/m2) IV
|
Cohort 2, Trastuzumab + Doxorubicin (50 mg/m2)
n=3 Participants
Trastuzumab and non-pegylated liposomal doxorubicin: Trastuzumab 3.6 mg/kg IV on Day 1 every 3 weeks and non-pegylated liposomal doxorubicin (50 mg/m2) IV
|
Cohort 3, Trastuzumab + Doxorubicin (60 mg/m2)
n=9 Participants
Trastuzumab and non-pegylated liposomal doxorubicin: Trastuzumab 3.6 mg/kg IV on Day 1 every 3 weeks and non-pegylated liposomal doxorubicin (60 mg/m2) IV
|
|---|---|---|---|
|
Progression-free Survival
|
8.2 months
Interval 1.3 to 10.3
|
7.0 months
Interval 3.8 to 10.2
|
7.2 months
Interval 4.5 to 9.6
|
SECONDARY outcome
Timeframe: Baseline up to 24 months after patient entryPatients with grade 3/4 adverse events, Serious Adverse Events (SAEs), deaths and discontinuations
Outcome measures
| Measure |
Cohort 1, Trastuzumab + Doxorubicin (45 mg/m2)
n=3 Participants
Trastuzumab and non-pegylated liposomal doxorubicin: Trastuzumab 3.6 mg/kg IV on Day 1 every 3 weeks and non-pegylated liposomal doxorubicin (45 mg/m2) IV
|
Cohort 2, Trastuzumab + Doxorubicin (50 mg/m2)
n=3 Participants
Trastuzumab and non-pegylated liposomal doxorubicin: Trastuzumab 3.6 mg/kg IV on Day 1 every 3 weeks and non-pegylated liposomal doxorubicin (50 mg/m2) IV
|
Cohort 3, Trastuzumab + Doxorubicin (60 mg/m2)
n=9 Participants
Trastuzumab and non-pegylated liposomal doxorubicin: Trastuzumab 3.6 mg/kg IV on Day 1 every 3 weeks and non-pegylated liposomal doxorubicin (60 mg/m2) IV
|
|---|---|---|---|
|
Grade 3/4 Adverse Events, SAEs, Deaths and Discontinuations
Neutropenia
|
0 participants
|
2 participants
|
6 participants
|
|
Grade 3/4 Adverse Events, SAEs, Deaths and Discontinuations
Thrombopenia
|
0 participants
|
0 participants
|
2 participants
|
|
Grade 3/4 Adverse Events, SAEs, Deaths and Discontinuations
Leukopenia
|
0 participants
|
1 participants
|
1 participants
|
|
Grade 3/4 Adverse Events, SAEs, Deaths and Discontinuations
Lymphopenia
|
0 participants
|
1 participants
|
1 participants
|
|
Grade 3/4 Adverse Events, SAEs, Deaths and Discontinuations
Increase in aspartate aminotransferase (AST)
|
0 participants
|
0 participants
|
2 participants
|
|
Grade 3/4 Adverse Events, SAEs, Deaths and Discontinuations
Fatigue
|
0 participants
|
0 participants
|
1 participants
|
SECONDARY outcome
Timeframe: Baseline up to 24 months after patient entryRate of patients who discontinued treatment due to Cardiac Function or Due to Cardiac Cause
Outcome measures
| Measure |
Cohort 1, Trastuzumab + Doxorubicin (45 mg/m2)
n=3 Participants
Trastuzumab and non-pegylated liposomal doxorubicin: Trastuzumab 3.6 mg/kg IV on Day 1 every 3 weeks and non-pegylated liposomal doxorubicin (45 mg/m2) IV
|
Cohort 2, Trastuzumab + Doxorubicin (50 mg/m2)
n=3 Participants
Trastuzumab and non-pegylated liposomal doxorubicin: Trastuzumab 3.6 mg/kg IV on Day 1 every 3 weeks and non-pegylated liposomal doxorubicin (50 mg/m2) IV
|
Cohort 3, Trastuzumab + Doxorubicin (60 mg/m2)
n=9 Participants
Trastuzumab and non-pegylated liposomal doxorubicin: Trastuzumab 3.6 mg/kg IV on Day 1 every 3 weeks and non-pegylated liposomal doxorubicin (60 mg/m2) IV
|
|---|---|---|---|
|
Discontinuation of the Study Drugs Due to Any Cardiotoxicity
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline up to 24 months after patient entryNew York Heart Association grading of Level II cardiotoxicities characterized by dose-independent reversible myocardial damage. The classes used in this system, I to IV with I indicating less severity and higher numbers indicating greater severity.
Outcome measures
| Measure |
Cohort 1, Trastuzumab + Doxorubicin (45 mg/m2)
n=3 Participants
Trastuzumab and non-pegylated liposomal doxorubicin: Trastuzumab 3.6 mg/kg IV on Day 1 every 3 weeks and non-pegylated liposomal doxorubicin (45 mg/m2) IV
|
Cohort 2, Trastuzumab + Doxorubicin (50 mg/m2)
n=3 Participants
Trastuzumab and non-pegylated liposomal doxorubicin: Trastuzumab 3.6 mg/kg IV on Day 1 every 3 weeks and non-pegylated liposomal doxorubicin (50 mg/m2) IV
|
Cohort 3, Trastuzumab + Doxorubicin (60 mg/m2)
n=9 Participants
Trastuzumab and non-pegylated liposomal doxorubicin: Trastuzumab 3.6 mg/kg IV on Day 1 every 3 weeks and non-pegylated liposomal doxorubicin (60 mg/m2) IV
|
|---|---|---|---|
|
Left Ventricular Dysfunction Class IV
|
0 Participants
|
1 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Baseline and after 4 cycles of treatment (Cycle4Day21)Serum human epidermal growth factor receptor 2 (HER-2) Levels (ng/mL) - Cycle 1 Day 1 and Cycle 4 Day 1.
Outcome measures
| Measure |
Cohort 1, Trastuzumab + Doxorubicin (45 mg/m2)
n=3 Participants
Trastuzumab and non-pegylated liposomal doxorubicin: Trastuzumab 3.6 mg/kg IV on Day 1 every 3 weeks and non-pegylated liposomal doxorubicin (45 mg/m2) IV
|
Cohort 2, Trastuzumab + Doxorubicin (50 mg/m2)
n=3 Participants
Trastuzumab and non-pegylated liposomal doxorubicin: Trastuzumab 3.6 mg/kg IV on Day 1 every 3 weeks and non-pegylated liposomal doxorubicin (50 mg/m2) IV
|
Cohort 3, Trastuzumab + Doxorubicin (60 mg/m2)
n=9 Participants
Trastuzumab and non-pegylated liposomal doxorubicin: Trastuzumab 3.6 mg/kg IV on Day 1 every 3 weeks and non-pegylated liposomal doxorubicin (60 mg/m2) IV
|
|---|---|---|---|
|
Serum HER-2 Levels
Baseline, Serum HER-2 (ng/mL)
|
12.7 ng/mL
Standard Deviation 5.8
|
38.1 ng/mL
Standard Deviation 35.7
|
17.5 ng/mL
Standard Deviation 6.0
|
|
Serum HER-2 Levels
Cycle 4 Day 21, Serum HER-2 (ng/mL)
|
7.4 ng/mL
Standard Deviation 0
|
15.2 ng/mL
Standard Deviation 0.6
|
18.8 ng/mL
Standard Deviation 5.4
|
SECONDARY outcome
Timeframe: Baseline (Cycle1Day1) and end of Cycle 2 (C2D21)Plasma concentration of Doxorubicinol using a validated liquid chromatography electrospray tandem mass spectrometry (LC-MS/MS) method
Outcome measures
| Measure |
Cohort 1, Trastuzumab + Doxorubicin (45 mg/m2)
n=3 Participants
Trastuzumab and non-pegylated liposomal doxorubicin: Trastuzumab 3.6 mg/kg IV on Day 1 every 3 weeks and non-pegylated liposomal doxorubicin (45 mg/m2) IV
|
Cohort 2, Trastuzumab + Doxorubicin (50 mg/m2)
n=3 Participants
Trastuzumab and non-pegylated liposomal doxorubicin: Trastuzumab 3.6 mg/kg IV on Day 1 every 3 weeks and non-pegylated liposomal doxorubicin (50 mg/m2) IV
|
Cohort 3, Trastuzumab + Doxorubicin (60 mg/m2)
n=9 Participants
Trastuzumab and non-pegylated liposomal doxorubicin: Trastuzumab 3.6 mg/kg IV on Day 1 every 3 weeks and non-pegylated liposomal doxorubicin (60 mg/m2) IV
|
|---|---|---|---|
|
Doxorubicinol - Concentration (Cmax)
Cycle 1 Day 1
|
14.8 μg/mL
Standard Deviation 8.4
|
9.19 μg/mL
Standard Deviation 42.1
|
15.2 μg/mL
Standard Deviation 70.6
|
|
Doxorubicinol - Concentration (Cmax)
Cycle 2 Day 21
|
16.0 μg/mL
Standard Deviation 25.2
|
10.1 μg/mL
Standard Deviation 38.9
|
15.6 μg/mL
Standard Deviation 54.5
|
SECONDARY outcome
Timeframe: Baseline (Cycle1Day1) and end of Cycle 2 (C2D21)Area under the plasma concentration versus time curve for the pharmacokinetic parameters for doxorubicinol by treatment dose level
Outcome measures
| Measure |
Cohort 1, Trastuzumab + Doxorubicin (45 mg/m2)
n=3 Participants
Trastuzumab and non-pegylated liposomal doxorubicin: Trastuzumab 3.6 mg/kg IV on Day 1 every 3 weeks and non-pegylated liposomal doxorubicin (45 mg/m2) IV
|
Cohort 2, Trastuzumab + Doxorubicin (50 mg/m2)
n=3 Participants
Trastuzumab and non-pegylated liposomal doxorubicin: Trastuzumab 3.6 mg/kg IV on Day 1 every 3 weeks and non-pegylated liposomal doxorubicin (50 mg/m2) IV
|
Cohort 3, Trastuzumab + Doxorubicin (60 mg/m2)
n=9 Participants
Trastuzumab and non-pegylated liposomal doxorubicin: Trastuzumab 3.6 mg/kg IV on Day 1 every 3 weeks and non-pegylated liposomal doxorubicin (60 mg/m2) IV
|
|---|---|---|---|
|
Doxorubicinol - Area Under Curve (AUC)
Cycle 1 Day 1- AUC
|
982 ng x h/mL
Standard Deviation 28.4
|
888 ng x h/mL
Standard Deviation 27.8
|
1340 ng x h/mL
Standard Deviation 65.0
|
|
Doxorubicinol - Area Under Curve (AUC)
Cycle 2 Day 21- AUC
|
899 ng x h/mL
Standard Deviation 40.7
|
763 ng x h/mL
Standard Deviation 25.4
|
1100 ng x h/mL
Standard Deviation 50.3
|
SECONDARY outcome
Timeframe: Baseline (Cycle1Day1) and end of Cycle 2 (C2D21)Apparent half-life for doxorubicinol by treatment dose level.
Outcome measures
| Measure |
Cohort 1, Trastuzumab + Doxorubicin (45 mg/m2)
n=3 Participants
Trastuzumab and non-pegylated liposomal doxorubicin: Trastuzumab 3.6 mg/kg IV on Day 1 every 3 weeks and non-pegylated liposomal doxorubicin (45 mg/m2) IV
|
Cohort 2, Trastuzumab + Doxorubicin (50 mg/m2)
n=3 Participants
Trastuzumab and non-pegylated liposomal doxorubicin: Trastuzumab 3.6 mg/kg IV on Day 1 every 3 weeks and non-pegylated liposomal doxorubicin (50 mg/m2) IV
|
Cohort 3, Trastuzumab + Doxorubicin (60 mg/m2)
n=9 Participants
Trastuzumab and non-pegylated liposomal doxorubicin: Trastuzumab 3.6 mg/kg IV on Day 1 every 3 weeks and non-pegylated liposomal doxorubicin (60 mg/m2) IV
|
|---|---|---|---|
|
Doxorubicinol - Apparent Half-life (t1/2)
Cycle 1 Day 1
|
93.4 days
Standard Deviation 37.9
|
78.5 days
Standard Deviation 6.0
|
69.3 days
Standard Deviation 11.7
|
|
Doxorubicinol - Apparent Half-life (t1/2)
Cycle 2 Day 21
|
51.91 days
Standard Deviation 0.5
|
64.01 days
Standard Deviation 23.6
|
49.41 days
Standard Deviation 1.9
|
SECONDARY outcome
Timeframe: Baseline (Cycle1Day1) and end of Cycle 2 (C2D21)Maximum concentration of drug in plasma (Tmax)
Outcome measures
| Measure |
Cohort 1, Trastuzumab + Doxorubicin (45 mg/m2)
n=3 Participants
Trastuzumab and non-pegylated liposomal doxorubicin: Trastuzumab 3.6 mg/kg IV on Day 1 every 3 weeks and non-pegylated liposomal doxorubicin (45 mg/m2) IV
|
Cohort 2, Trastuzumab + Doxorubicin (50 mg/m2)
n=3 Participants
Trastuzumab and non-pegylated liposomal doxorubicin: Trastuzumab 3.6 mg/kg IV on Day 1 every 3 weeks and non-pegylated liposomal doxorubicin (50 mg/m2) IV
|
Cohort 3, Trastuzumab + Doxorubicin (60 mg/m2)
n=9 Participants
Trastuzumab and non-pegylated liposomal doxorubicin: Trastuzumab 3.6 mg/kg IV on Day 1 every 3 weeks and non-pegylated liposomal doxorubicin (60 mg/m2) IV
|
|---|---|---|---|
|
Doxorubicinol - Tmax
Cycle 1 Day 1- Tmax
|
3.75 hours
Interval 3.58 to 3.75
|
3.58 hours
Interval 3.58 to 3.92
|
3.63 hours
Interval 3.5 to 3.83
|
|
Doxorubicinol - Tmax
Cycle 2 Day 21- Tmax
|
4.02 hours
Interval 4.0 to 4.23
|
3.58 hours
Interval 1.17 to 4.15
|
3.78 hours
Interval 3.75 to 4.0
|
SECONDARY outcome
Timeframe: Baseline (Cycle1 Day1)Pharmacokinetic parameters for trastuzumab
Outcome measures
| Measure |
Cohort 1, Trastuzumab + Doxorubicin (45 mg/m2)
n=3 Participants
Trastuzumab and non-pegylated liposomal doxorubicin: Trastuzumab 3.6 mg/kg IV on Day 1 every 3 weeks and non-pegylated liposomal doxorubicin (45 mg/m2) IV
|
Cohort 2, Trastuzumab + Doxorubicin (50 mg/m2)
n=3 Participants
Trastuzumab and non-pegylated liposomal doxorubicin: Trastuzumab 3.6 mg/kg IV on Day 1 every 3 weeks and non-pegylated liposomal doxorubicin (50 mg/m2) IV
|
Cohort 3, Trastuzumab + Doxorubicin (60 mg/m2)
n=9 Participants
Trastuzumab and non-pegylated liposomal doxorubicin: Trastuzumab 3.6 mg/kg IV on Day 1 every 3 weeks and non-pegylated liposomal doxorubicin (60 mg/m2) IV
|
|---|---|---|---|
|
Trastuzumab - Cmax
|
94.6 μg/mL
Standard Deviation 16.8
|
114 μg/mL
Standard Deviation 2.8
|
78.3 μg/mL
Standard Deviation 7.6
|
SECONDARY outcome
Timeframe: Baseline (Cycle1Day1)Pharmacokinetic parameters for trastuzumab
Outcome measures
| Measure |
Cohort 1, Trastuzumab + Doxorubicin (45 mg/m2)
n=3 Participants
Trastuzumab and non-pegylated liposomal doxorubicin: Trastuzumab 3.6 mg/kg IV on Day 1 every 3 weeks and non-pegylated liposomal doxorubicin (45 mg/m2) IV
|
Cohort 2, Trastuzumab + Doxorubicin (50 mg/m2)
n=3 Participants
Trastuzumab and non-pegylated liposomal doxorubicin: Trastuzumab 3.6 mg/kg IV on Day 1 every 3 weeks and non-pegylated liposomal doxorubicin (50 mg/m2) IV
|
Cohort 3, Trastuzumab + Doxorubicin (60 mg/m2)
n=9 Participants
Trastuzumab and non-pegylated liposomal doxorubicin: Trastuzumab 3.6 mg/kg IV on Day 1 every 3 weeks and non-pegylated liposomal doxorubicin (60 mg/m2) IV
|
|---|---|---|---|
|
Trastuzumab - AUC
|
348 μg x h/mL
Standard Deviation 14.4
|
372 μg x h/mL
Standard Deviation 30.3
|
317 μg x h/mL
Standard Deviation 18.9
|
SECONDARY outcome
Timeframe: Baseline (Cycle1Day1)Pharmacokinetic parameters for trastuzumab
Outcome measures
| Measure |
Cohort 1, Trastuzumab + Doxorubicin (45 mg/m2)
n=3 Participants
Trastuzumab and non-pegylated liposomal doxorubicin: Trastuzumab 3.6 mg/kg IV on Day 1 every 3 weeks and non-pegylated liposomal doxorubicin (45 mg/m2) IV
|
Cohort 2, Trastuzumab + Doxorubicin (50 mg/m2)
n=3 Participants
Trastuzumab and non-pegylated liposomal doxorubicin: Trastuzumab 3.6 mg/kg IV on Day 1 every 3 weeks and non-pegylated liposomal doxorubicin (50 mg/m2) IV
|
Cohort 3, Trastuzumab + Doxorubicin (60 mg/m2)
n=9 Participants
Trastuzumab and non-pegylated liposomal doxorubicin: Trastuzumab 3.6 mg/kg IV on Day 1 every 3 weeks and non-pegylated liposomal doxorubicin (60 mg/m2) IV
|
|---|---|---|---|
|
Trastuzumab - Tmax
|
1.95 hours
Interval 1.83 to 2.0
|
1.83 hours
Interval 1.83 to 2.02
|
1.95 hours
Interval 1.8 to 2.08
|
SECONDARY outcome
Timeframe: Baseline (Cycle1Day1)Pharmacokinetic parameters for emtansine (DM1) by treatment dose level
Outcome measures
| Measure |
Cohort 1, Trastuzumab + Doxorubicin (45 mg/m2)
n=3 Participants
Trastuzumab and non-pegylated liposomal doxorubicin: Trastuzumab 3.6 mg/kg IV on Day 1 every 3 weeks and non-pegylated liposomal doxorubicin (45 mg/m2) IV
|
Cohort 2, Trastuzumab + Doxorubicin (50 mg/m2)
n=3 Participants
Trastuzumab and non-pegylated liposomal doxorubicin: Trastuzumab 3.6 mg/kg IV on Day 1 every 3 weeks and non-pegylated liposomal doxorubicin (50 mg/m2) IV
|
Cohort 3, Trastuzumab + Doxorubicin (60 mg/m2)
n=9 Participants
Trastuzumab and non-pegylated liposomal doxorubicin: Trastuzumab 3.6 mg/kg IV on Day 1 every 3 weeks and non-pegylated liposomal doxorubicin (60 mg/m2) IV
|
|---|---|---|---|
|
DM-1 - Cmax
|
3.76 μg/mL
Standard Deviation 18.2
|
8.03 μg/mL
Standard Deviation 67.3
|
5.13 μg/mL
Standard Deviation 59.1
|
SECONDARY outcome
Timeframe: Baseline (Cycle1Day1)Pharmacokinetic parameters for DM1 by treatment dose level
Outcome measures
| Measure |
Cohort 1, Trastuzumab + Doxorubicin (45 mg/m2)
n=3 Participants
Trastuzumab and non-pegylated liposomal doxorubicin: Trastuzumab 3.6 mg/kg IV on Day 1 every 3 weeks and non-pegylated liposomal doxorubicin (45 mg/m2) IV
|
Cohort 2, Trastuzumab + Doxorubicin (50 mg/m2)
n=3 Participants
Trastuzumab and non-pegylated liposomal doxorubicin: Trastuzumab 3.6 mg/kg IV on Day 1 every 3 weeks and non-pegylated liposomal doxorubicin (50 mg/m2) IV
|
Cohort 3, Trastuzumab + Doxorubicin (60 mg/m2)
n=9 Participants
Trastuzumab and non-pegylated liposomal doxorubicin: Trastuzumab 3.6 mg/kg IV on Day 1 every 3 weeks and non-pegylated liposomal doxorubicin (60 mg/m2) IV
|
|---|---|---|---|
|
DM-1 - AUC
|
23.1 μg x h/mL
Standard Deviation 143.1
|
10.1 μg x h/mL
Standard Deviation 25.0
|
5.63 μg x h/mL
Standard Deviation 24.9
|
SECONDARY outcome
Timeframe: Baseline (Cycle1Day1)Pharmacokinetic parameters for DM1 by treatment dose level
Outcome measures
| Measure |
Cohort 1, Trastuzumab + Doxorubicin (45 mg/m2)
n=3 Participants
Trastuzumab and non-pegylated liposomal doxorubicin: Trastuzumab 3.6 mg/kg IV on Day 1 every 3 weeks and non-pegylated liposomal doxorubicin (45 mg/m2) IV
|
Cohort 2, Trastuzumab + Doxorubicin (50 mg/m2)
n=3 Participants
Trastuzumab and non-pegylated liposomal doxorubicin: Trastuzumab 3.6 mg/kg IV on Day 1 every 3 weeks and non-pegylated liposomal doxorubicin (50 mg/m2) IV
|
Cohort 3, Trastuzumab + Doxorubicin (60 mg/m2)
n=9 Participants
Trastuzumab and non-pegylated liposomal doxorubicin: Trastuzumab 3.6 mg/kg IV on Day 1 every 3 weeks and non-pegylated liposomal doxorubicin (60 mg/m2) IV
|
|---|---|---|---|
|
DM-1 - Tmax
|
2.0 hours
Interval 1.95 to 581.0
|
1.83 hours
Interval 1.83 to 2.02
|
1.95 hours
Interval 1.8 to 2.08
|
Adverse Events
Cohort 1, Trastuzumab + Doxorubicin (45 mg/m2)
Serious events: 1 serious events
Other events: 3 other events
Deaths: 1 deaths
Cohort 2, Trastuzumab + Doxorubicin (50 mg/m2)
Serious events: 0 serious events
Other events: 3 other events
Deaths: 1 deaths
Cohort 3, Trastuzumab + Doxorubicin (60 mg/m2)
Serious events: 1 serious events
Other events: 9 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Cohort 1, Trastuzumab + Doxorubicin (45 mg/m2)
n=3 participants at risk
Trastuzumab and non-pegylated liposomal doxorubicin: Trastuzumab 3.6 mg/kg IV on Day 1 every 3 weeks and non-pegylated liposomal doxorubicin (45 mg/m2) IV
|
Cohort 2, Trastuzumab + Doxorubicin (50 mg/m2)
n=3 participants at risk
Trastuzumab and non-pegylated liposomal doxorubicin: Trastuzumab 3.6 mg/kg IV on Day 1 every 3 weeks and non-pegylated liposomal doxorubicin (50 mg/m2) IV
|
Cohort 3, Trastuzumab + Doxorubicin (60 mg/m2)
n=9 participants at risk
Trastuzumab and non-pegylated liposomal doxorubicin: Trastuzumab 3.6 mg/kg IV on Day 1 every 3 weeks and non-pegylated liposomal doxorubicin (60 mg/m2) IV
|
|---|---|---|---|
|
Gastrointestinal disorders
Infections and infestations
|
0.00%
0/3 • Baseline up to 24 months after patient entry
|
0.00%
0/3 • Baseline up to 24 months after patient entry
|
11.1%
1/9 • Number of events 1 • Baseline up to 24 months after patient entry
|
|
Blood and lymphatic system disorders
Investigations
|
0.00%
0/3 • Baseline up to 24 months after patient entry
|
0.00%
0/3 • Baseline up to 24 months after patient entry
|
11.1%
1/9 • Number of events 1 • Baseline up to 24 months after patient entry
|
|
Nervous system disorders
Nervous system disorders
|
33.3%
1/3 • Number of events 1 • Baseline up to 24 months after patient entry
|
0.00%
0/3 • Baseline up to 24 months after patient entry
|
0.00%
0/9 • Baseline up to 24 months after patient entry
|
|
Nervous system disorders
Nervous system disorder
|
33.3%
1/3 • Number of events 1 • Baseline up to 24 months after patient entry
|
0.00%
0/3 • Baseline up to 24 months after patient entry
|
0.00%
0/9 • Baseline up to 24 months after patient entry
|
Other adverse events
| Measure |
Cohort 1, Trastuzumab + Doxorubicin (45 mg/m2)
n=3 participants at risk
Trastuzumab and non-pegylated liposomal doxorubicin: Trastuzumab 3.6 mg/kg IV on Day 1 every 3 weeks and non-pegylated liposomal doxorubicin (45 mg/m2) IV
|
Cohort 2, Trastuzumab + Doxorubicin (50 mg/m2)
n=3 participants at risk
Trastuzumab and non-pegylated liposomal doxorubicin: Trastuzumab 3.6 mg/kg IV on Day 1 every 3 weeks and non-pegylated liposomal doxorubicin (50 mg/m2) IV
|
Cohort 3, Trastuzumab + Doxorubicin (60 mg/m2)
n=9 participants at risk
Trastuzumab and non-pegylated liposomal doxorubicin: Trastuzumab 3.6 mg/kg IV on Day 1 every 3 weeks and non-pegylated liposomal doxorubicin (60 mg/m2) IV
|
|---|---|---|---|
|
General disorders
Asthenia
|
100.0%
3/3 • Number of events 3 • Baseline up to 24 months after patient entry
|
66.7%
2/3 • Number of events 2 • Baseline up to 24 months after patient entry
|
77.8%
7/9 • Number of events 7 • Baseline up to 24 months after patient entry
|
|
General disorders
Fatigue
|
0.00%
0/3 • Baseline up to 24 months after patient entry
|
0.00%
0/3 • Baseline up to 24 months after patient entry
|
22.2%
2/9 • Number of events 2 • Baseline up to 24 months after patient entry
|
|
General disorders
Mucosal inflammation
|
0.00%
0/3 • Baseline up to 24 months after patient entry
|
0.00%
0/3 • Baseline up to 24 months after patient entry
|
22.2%
2/9 • Number of events 2 • Baseline up to 24 months after patient entry
|
|
General disorders
Gait disturbance
|
33.3%
1/3 • Number of events 1 • Baseline up to 24 months after patient entry
|
0.00%
0/3 • Baseline up to 24 months after patient entry
|
0.00%
0/9 • Baseline up to 24 months after patient entry
|
|
General disorders
Pyrexia
|
0.00%
0/3 • Baseline up to 24 months after patient entry
|
33.3%
1/3 • Number of events 1 • Baseline up to 24 months after patient entry
|
0.00%
0/9 • Baseline up to 24 months after patient entry
|
|
Blood and lymphatic system disorders
Neutrophil count decreased
|
33.3%
1/3 • Number of events 1 • Baseline up to 24 months after patient entry
|
100.0%
3/3 • Number of events 3 • Baseline up to 24 months after patient entry
|
77.8%
7/9 • Number of events 7 • Baseline up to 24 months after patient entry
|
|
Blood and lymphatic system disorders
Platelet count decreased
|
33.3%
1/3 • Number of events 1 • Baseline up to 24 months after patient entry
|
66.7%
2/3 • Number of events 2 • Baseline up to 24 months after patient entry
|
66.7%
6/9 • Number of events 6 • Baseline up to 24 months after patient entry
|
|
Blood and lymphatic system disorders
Aspartate aminotransferase (AST) increased
|
33.3%
1/3 • Number of events 1 • Baseline up to 24 months after patient entry
|
33.3%
1/3 • Number of events 1 • Baseline up to 24 months after patient entry
|
66.7%
6/9 • Number of events 6 • Baseline up to 24 months after patient entry
|
|
Blood and lymphatic system disorders
Alanine aminotransferase (ALT) increased
|
33.3%
1/3 • Number of events 1 • Baseline up to 24 months after patient entry
|
33.3%
1/3 • Number of events 1 • Baseline up to 24 months after patient entry
|
44.4%
4/9 • Number of events 4 • Baseline up to 24 months after patient entry
|
|
Cardiac disorders
Brain natriuretic peptide increased
|
0.00%
0/3 • Baseline up to 24 months after patient entry
|
66.7%
2/3 • Number of events 2 • Baseline up to 24 months after patient entry
|
44.4%
4/9 • Number of events 4 • Baseline up to 24 months after patient entry
|
|
Hepatobiliary disorders
Gamma-glutamyltransferase increased
|
66.7%
2/3 • Number of events 2 • Baseline up to 24 months after patient entry
|
66.7%
2/3 • Number of events 2 • Baseline up to 24 months after patient entry
|
22.2%
2/9 • Number of events 2 • Baseline up to 24 months after patient entry
|
|
Cardiac disorders
Troponin increased
|
0.00%
0/3 • Baseline up to 24 months after patient entry
|
33.3%
1/3 • Number of events 1 • Baseline up to 24 months after patient entry
|
44.4%
4/9 • Number of events 4 • Baseline up to 24 months after patient entry
|
|
Blood and lymphatic system disorders
White blood cell count decreased
|
0.00%
0/3 • Baseline up to 24 months after patient entry
|
33.3%
1/3 • Number of events 1 • Baseline up to 24 months after patient entry
|
22.2%
2/9 • Number of events 2 • Baseline up to 24 months after patient entry
|
|
Hepatobiliary disorders
Blood alkaline phosphatase increased
|
0.00%
0/3 • Baseline up to 24 months after patient entry
|
33.3%
1/3 • Number of events 1 • Baseline up to 24 months after patient entry
|
11.1%
1/9 • Number of events 1 • Baseline up to 24 months after patient entry
|
|
Blood and lymphatic system disorders
Haemoglobin decreased
|
33.3%
1/3 • Number of events 1 • Baseline up to 24 months after patient entry
|
33.3%
1/3 • Number of events 1 • Baseline up to 24 months after patient entry
|
0.00%
0/9 • Baseline up to 24 months after patient entry
|
|
Blood and lymphatic system disorders
Lymphocyte count decreased
|
0.00%
0/3 • Baseline up to 24 months after patient entry
|
33.3%
1/3 • Number of events 1 • Baseline up to 24 months after patient entry
|
11.1%
1/9 • Number of events 1 • Baseline up to 24 months after patient entry
|
|
Hepatobiliary disorders
Alanine aminotransferase abnormal
|
0.00%
0/3 • Baseline up to 24 months after patient entry
|
33.3%
1/3 • Number of events 1 • Baseline up to 24 months after patient entry
|
0.00%
0/9 • Baseline up to 24 months after patient entry
|
|
Metabolism and nutrition disorders
Blood albumin decreased
|
33.3%
1/3 • Number of events 1 • Baseline up to 24 months after patient entry
|
0.00%
0/3 • Baseline up to 24 months after patient entry
|
0.00%
0/9 • Baseline up to 24 months after patient entry
|
|
Hepatobiliary disorders
Blood alkaline phosphatase abnormal
|
0.00%
0/3 • Baseline up to 24 months after patient entry
|
33.3%
1/3 • Number of events 1 • Baseline up to 24 months after patient entry
|
0.00%
0/9 • Baseline up to 24 months after patient entry
|
|
Blood and lymphatic system disorders
Platelet count abnormal
|
0.00%
0/3 • Baseline up to 24 months after patient entry
|
0.00%
0/3 • Baseline up to 24 months after patient entry
|
11.1%
1/9 • Number of events 1 • Baseline up to 24 months after patient entry
|
|
Gastrointestinal disorders
Gastrointestinal disorders
|
100.0%
3/3 • Number of events 3 • Baseline up to 24 months after patient entry
|
100.0%
3/3 • Number of events 3 • Baseline up to 24 months after patient entry
|
55.6%
5/9 • Number of events 5 • Baseline up to 24 months after patient entry
|
|
Metabolism and nutrition disorders
Metabolism and nutrition disorders
|
33.3%
1/3 • Number of events 1 • Baseline up to 24 months after patient entry
|
66.7%
2/3 • Number of events 2 • Baseline up to 24 months after patient entry
|
44.4%
4/9 • Number of events 4 • Baseline up to 24 months after patient entry
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders
|
0.00%
0/3 • Baseline up to 24 months after patient entry
|
66.7%
2/3 • Number of events 2 • Baseline up to 24 months after patient entry
|
55.6%
5/9 • Number of events 5 • Baseline up to 24 months after patient entry
|
|
Blood and lymphatic system disorders
Blood and lymphatic system disorders
|
0.00%
0/3 • Baseline up to 24 months after patient entry
|
33.3%
1/3 • Number of events 1 • Baseline up to 24 months after patient entry
|
55.6%
5/9 • Number of events 5 • Baseline up to 24 months after patient entry
|
|
Eye disorders
Eye disorders
|
0.00%
0/3 • Baseline up to 24 months after patient entry
|
33.3%
1/3 • Number of events 1 • Baseline up to 24 months after patient entry
|
33.3%
3/9 • Number of events 3 • Baseline up to 24 months after patient entry
|
|
Nervous system disorders
Nervous system disorders
|
33.3%
1/3 • Number of events 1 • Baseline up to 24 months after patient entry
|
66.7%
2/3 • Number of events 2 • Baseline up to 24 months after patient entry
|
11.1%
1/9 • Number of events 1 • Baseline up to 24 months after patient entry
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders
|
0.00%
0/3 • Baseline up to 24 months after patient entry
|
66.7%
2/3 • Number of events 2 • Baseline up to 24 months after patient entry
|
22.2%
2/9 • Number of events 2 • Baseline up to 24 months after patient entry
|
|
Hepatobiliary disorders
Hepatobiliary disorders
|
33.3%
1/3 • Number of events 1 • Baseline up to 24 months after patient entry
|
0.00%
0/3 • Baseline up to 24 months after patient entry
|
11.1%
1/9 • Number of events 1 • Baseline up to 24 months after patient entry
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/3 • Baseline up to 24 months after patient entry
|
33.3%
1/3 • Number of events 1 • Baseline up to 24 months after patient entry
|
11.1%
1/9 • Number of events 1 • Baseline up to 24 months after patient entry
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/3 • Baseline up to 24 months after patient entry
|
0.00%
0/3 • Baseline up to 24 months after patient entry
|
11.1%
1/9 • Number of events 1 • Baseline up to 24 months after patient entry
|
|
Ear and labyrinth disorders
Hyperacusis
|
0.00%
0/3 • Baseline up to 24 months after patient entry
|
0.00%
0/3 • Baseline up to 24 months after patient entry
|
11.1%
1/9 • Number of events 1 • Baseline up to 24 months after patient entry
|
|
Reproductive system and breast disorders
Vulvovaginal dryness
|
0.00%
0/3 • Baseline up to 24 months after patient entry
|
33.3%
1/3 • Number of events 1 • Baseline up to 24 months after patient entry
|
0.00%
0/9 • Baseline up to 24 months after patient entry
|
|
Vascular disorders
Hot flush
|
0.00%
0/3 • Baseline up to 24 months after patient entry
|
0.00%
0/3 • Baseline up to 24 months after patient entry
|
11.1%
1/9 • Number of events 1 • Baseline up to 24 months after patient entry
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/3 • Baseline up to 24 months after patient entry
|
0.00%
0/3 • Baseline up to 24 months after patient entry
|
44.4%
4/9 • Number of events 4 • Baseline up to 24 months after patient entry
|
|
Nervous system disorders
Headache
|
0.00%
0/3 • Baseline up to 24 months after patient entry
|
66.7%
2/3 • Number of events 2 • Baseline up to 24 months after patient entry
|
0.00%
0/9 • Baseline up to 24 months after patient entry
|
Additional Information
Scientific director
Medica Scientia Innovation Research (MEDSIR)
Phone: +34 93 221 41 35
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place