Trial Outcomes & Findings for Safety Study of CAELYX in Patients With Metastatic Breast Cancer Previously Treated With Anthracyclines (Study P04057)(TERMINATED) (NCT NCT00779285)

Results Overview

A cardiac event was defined as a decrease in left ventricular ejection fraction (LVEF) of \>=20 points from baseline if the resting LVEF remained in the normal range, or a decrease of \>=10 points if the LVEF became abnormal (lower than the institutional lower limit of normal).

Recruitment status

TERMINATED

Study phase

PHASE4

Target enrollment

1 participants

Primary outcome timeframe

Every 4 weeks during 6 cycles.

Results posted on

2015-07-14

Participant Flow

Participant milestones

Participant milestones
Measure	Caelyx Pegylated Lyposomal Doxorubicin (Caelyx) 50 mg/m2, given for 6 cycles
Overall Study STARTED	1
Overall Study COMPLETED	1
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Safety Study of CAELYX in Patients With Metastatic Breast Cancer Previously Treated With Anthracyclines (Study P04057)(TERMINATED)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Caelyx n=1 Participants Pegylated Lyposomal Doxorubicin (Caelyx) 50 mg/m2, given for 6 cycles
Age, Customized	1 participants n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Region of Enrollment Hungary	1 participants n=5 Participants

PRIMARY outcome

Timeframe: Every 4 weeks during 6 cycles.

A cardiac event was defined as a decrease in left ventricular ejection fraction (LVEF) of \>=20 points from baseline if the resting LVEF remained in the normal range, or a decrease of \>=10 points if the LVEF became abnormal (lower than the institutional lower limit of normal).

Outcome measures

Outcome measures
Measure	Caelyx n=1 Participants Pegylated Lyposomal Doxorubicin (Caelyx) 50 mg/m2, given for 6 cycles
Cardiac Events	0 Cardiac Events

Adverse Events

Caelyx

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Caelyx n=1 participants at risk Pegylated Lyposomal Doxorubicin (Caelyx) 50 mg/m2, given for 6 cycles
Skin and subcutaneous tissue disorders Maculopapulosus exanthema	100.0% 1/1 • Number of events 1

Additional Information

Senior Vice President, Global Clinical Development

Merck Sharp & Dohme Corp.

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Principal investigator agrees not to publish/publicly present any interim results without prior Sponsor written consent and agrees to provide 30 days written notice prior to submission to permit review of abstracts/manuscripts which report any results. Sponsor has the right to review/comment/edit to ensure confidentiality, information accuracy, and that the presentation is fairly balanced. If the parties disagree, the investigator agrees to meet with Sponsor to discuss/resolve any disagreement.
Publication restrictions are in place

Restriction type: OTHER