Trial Outcomes & Findings for A Study to Determine the Activity of Caelyx With Trastuzumab and Docetaxel in the Treatment of Metastatic Breast Cancer (Study P03679) (NCT NCT00687440)
NCT ID: NCT00687440
Last Updated: 2018-07-03
Results Overview
Those who achieved either complete (disappearance of all target lesions) or partial (at least 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD) response.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
27 participants
Primary outcome timeframe
Week 09, Week 18, at the end of each patient's treatment, and at 3, 6, 9, and 12 months after end of treatment.
Results posted on
2018-07-03
Participant Flow
Participant milestones
| Measure |
Caelyx, Docetaxel, Trastuzumab
Stage 1: subjects will receive Caelyx one day every 3 weeks in combination with docetaxel one day every 3 weeks and trastuzumab once weekly during 6 cycles. At the end of this stage, based on the number of cardiac events, subjects will proceed to a second stage or restart with a lower dose of Caelyx.
Stage 2: subjects will be treated with the recommended dose of Caelyx (defined in the first stage) in combination with docetaxel and trastuzumab.
|
|---|---|
|
Overall Study
STARTED
|
27
|
|
Overall Study
COMPLETED
|
15
|
|
Overall Study
NOT COMPLETED
|
12
|
Reasons for withdrawal
| Measure |
Caelyx, Docetaxel, Trastuzumab
Stage 1: subjects will receive Caelyx one day every 3 weeks in combination with docetaxel one day every 3 weeks and trastuzumab once weekly during 6 cycles. At the end of this stage, based on the number of cardiac events, subjects will proceed to a second stage or restart with a lower dose of Caelyx.
Stage 2: subjects will be treated with the recommended dose of Caelyx (defined in the first stage) in combination with docetaxel and trastuzumab.
|
|---|---|
|
Overall Study
Adverse Event
|
3
|
|
Overall Study
Lost to Follow-up
|
3
|
|
Overall Study
Lack of Efficacy
|
2
|
|
Overall Study
Death
|
2
|
|
Overall Study
Other
|
1
|
|
Overall Study
Missing
|
1
|
Baseline Characteristics
A Study to Determine the Activity of Caelyx With Trastuzumab and Docetaxel in the Treatment of Metastatic Breast Cancer (Study P03679)
Baseline characteristics by cohort
| Measure |
Caelyx, Docetaxel, Trastuzumab
n=27 Participants
Stage 1: subjects will receive Caelyx one day every 3 weeks in combination with docetaxel one day every 3 weeks and trastuzumab once weekly during 6 cycles. At the end of this stage, based on the number of cardiac events, subjects will proceed to a second stage or restart with a lower dose of Caelyx.
Stage 2: subjects will be treated with the recommended dose of Caelyx (defined in the first stage) in combination with docetaxel and trastuzumab.
|
|---|---|
|
Age, Customized
|
27 years
n=93 Participants
|
|
Sex: Female, Male
Female
|
27 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=93 Participants
|
|
Region of Enrollment
Italy
|
27 participants
n=93 Participants
|
PRIMARY outcome
Timeframe: Week 09, Week 18, at the end of each patient's treatment, and at 3, 6, 9, and 12 months after end of treatment.Population: Intent-to-treat population
Those who achieved either complete (disappearance of all target lesions) or partial (at least 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD) response.
Outcome measures
| Measure |
Caelyx, Docetaxel, Trastuzumab
n=26 Participants
Stage 1: subjects will receive Caelyx one day every 3 weeks in combination with docetaxel one day every 3 weeks and trastuzumab once weekly during 6 cycles. At the end of this stage, based on the number of cardiac events, subjects will proceed to a second stage or restart with a lower dose of Caelyx.
Stage 2: subjects will be treated with the recommended dose of Caelyx (defined in the first stage) in combination with docetaxel and trastuzumab.
|
|---|---|
|
Number of Participants Who Had a Tumor Response, According to Standard RECIST (Response Evaluation Criteria in Solid Tumors) Criteria
Participants who had a complete tumor response
|
2 Participants
|
|
Number of Participants Who Had a Tumor Response, According to Standard RECIST (Response Evaluation Criteria in Solid Tumors) Criteria
Participants who had a partial tumor response
|
13 Participants
|
|
Number of Participants Who Had a Tumor Response, According to Standard RECIST (Response Evaluation Criteria in Solid Tumors) Criteria
Participants who did not have a tumor response
|
11 Participants
|
Adverse Events
Caelyx, Docetaxel, Trastuzumab
Serious events: 6 serious events
Other events: 21 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Caelyx, Docetaxel, Trastuzumab
n=27 participants at risk
|
|---|---|
|
Blood and lymphatic system disorders
NEUTROPENIA
|
3.7%
1/27 • Number of events 1
|
|
Gastrointestinal disorders
STOMATITIS
|
3.7%
1/27 • Number of events 1
|
|
Gastrointestinal disorders
VOMITING
|
3.7%
1/27 • Number of events 1
|
|
General disorders
MUCOSAL INFLAMMATION
|
3.7%
1/27 • Number of events 1
|
|
General disorders
PYREXIA
|
3.7%
1/27 • Number of events 1
|
|
Infections and infestations
SEPSIS
|
3.7%
1/27 • Number of events 1
|
|
Investigations
EJECTION FRACTION DECREASED
|
3.7%
1/27 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
METASTASES TO MENINGES
|
3.7%
1/27 • Number of events 1
|
|
Nervous system disorders
COMA
|
3.7%
1/27 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
PULMONARY OEDEMA
|
3.7%
1/27 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
PALMAR-PLANTAR ERYTHRODYSAESTHESIA SYNDROME
|
7.4%
2/27 • Number of events 2
|
|
Vascular disorders
HYPOTENSION
|
3.7%
1/27 • Number of events 1
|
Other adverse events
| Measure |
Caelyx, Docetaxel, Trastuzumab
n=27 participants at risk
|
|---|---|
|
Blood and lymphatic system disorders
LEUKOPENIA
|
18.5%
5/27 • Number of events 18
|
|
Blood and lymphatic system disorders
LYMPHOPENIA
|
7.4%
2/27 • Number of events 10
|
|
Blood and lymphatic system disorders
NEUTROPENIA
|
18.5%
5/27 • Number of events 10
|
|
Gastrointestinal disorders
ABDOMINAL PAIN
|
11.1%
3/27 • Number of events 8
|
|
Gastrointestinal disorders
ABDOMINAL PAIN UPPER
|
11.1%
3/27 • Number of events 6
|
|
Gastrointestinal disorders
CONSTIPATION
|
11.1%
3/27 • Number of events 5
|
|
Gastrointestinal disorders
DIARRHOEA
|
25.9%
7/27 • Number of events 11
|
|
Gastrointestinal disorders
GASTRITIS
|
7.4%
2/27 • Number of events 2
|
|
Gastrointestinal disorders
NAUSEA
|
29.6%
8/27 • Number of events 9
|
|
Gastrointestinal disorders
STOMATITIS
|
25.9%
7/27 • Number of events 28
|
|
Gastrointestinal disorders
VOMITING
|
11.1%
3/27 • Number of events 3
|
|
General disorders
ASTHENIA
|
29.6%
8/27 • Number of events 10
|
|
General disorders
CHEST PAIN
|
7.4%
2/27 • Number of events 5
|
|
General disorders
FATIGUE
|
7.4%
2/27 • Number of events 3
|
|
General disorders
MUCOSAL INFLAMMATION
|
22.2%
6/27 • Number of events 22
|
|
General disorders
OEDEMA PERIPHERAL
|
7.4%
2/27 • Number of events 3
|
|
General disorders
PYREXIA
|
22.2%
6/27 • Number of events 7
|
|
Nervous system disorders
HEADACHE
|
7.4%
2/27 • Number of events 2
|
|
Nervous system disorders
PARAESTHESIA
|
11.1%
3/27 • Number of events 3
|
|
Skin and subcutaneous tissue disorders
ALOPECIA
|
14.8%
4/27 • Number of events 4
|
|
Skin and subcutaneous tissue disorders
NAIL DISORDER
|
7.4%
2/27 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
ONYCHOLYSIS
|
7.4%
2/27 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
PALMAR-PLANTAR ERYTHRODYSAESTHESIA SYNDROME
|
59.3%
16/27 • Number of events 43
|
|
Skin and subcutaneous tissue disorders
RASH
|
11.1%
3/27 • Number of events 4
|
Additional Information
Senior Vice President, Global Clinical Development
Merck Sharp & Dohme Corp.
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place