Trial Outcomes & Findings for A Study of Docetaxel Monotherapy or DOXIL and Docetaxel in Patients With Advanced Breast Cancer (NCT NCT00091442)

Last Updated: 2014-04-21

Results Overview

Time interval in months between the date of randomization and the date of disease progression or death due to progression, whichever occurred first.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

751 participants

Primary outcome timeframe

From date of randomization until date of disease progression or death, whichever occurred first, until approximately 485 events of disease progression or death were observed, as assessed approximately 15 months after the last patient was enrolled

Results posted on

2014-04-21

Participant Flow

A total of 751 participants were enrolled and randomized at 143 sites in 19 countries.

751 participants were randomly assigned to 2 treatment groups (Docetaxel: 373 ; DOXIL+docetaxel: 378). 750 participants received treatment (Docetaxel: 373; DOXIL+docetaxel: 377). 1 participant in DOXIL+docetaxel treatment group did not receive treatment.

Participant milestones

Participant milestones
Measure	Docetaxel Docetaxel monotherapy: Docetaxel 75 mg/m2 solution administered by intravenous infusion over 1 hour on Day 1 of every 21-day cycle.	DOXIL+Docetaxel DOXIL and docetaxel combination: DOXIL 30 mg/m2 solution administered by intravenous infusion, followed by docetaxel 60 mg/m2 administration by intravenous infusion over 1 hour on Day 1 of every 21-day cycle.
Overall Study STARTED	373	378
Overall Study COMPLETED	4	5
Overall Study NOT COMPLETED	369	373

Reasons for withdrawal

Reasons for withdrawal
Measure	Docetaxel Docetaxel monotherapy: Docetaxel 75 mg/m2 solution administered by intravenous infusion over 1 hour on Day 1 of every 21-day cycle.	DOXIL+Docetaxel DOXIL and docetaxel combination: DOXIL 30 mg/m2 solution administered by intravenous infusion, followed by docetaxel 60 mg/m2 administration by intravenous infusion over 1 hour on Day 1 of every 21-day cycle.
Overall Study Progressive Disease	220	189
Overall Study Physician Decision	61	58
Overall Study Withdrawal by Subject	38	46
Overall Study Adverse Event	29	48
Overall Study 2cycles therapy beyond Complete response	9	16
Overall Study Death	9	7
Overall Study Lost to Follow-up	1	3
Overall Study Other	2	6

Baseline Characteristics

A Study of Docetaxel Monotherapy or DOXIL and Docetaxel in Patients With Advanced Breast Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Docetaxel n=373 Participants Docetaxel monotherapy: Docetaxel 75 mg/m2 solution administered by intravenous infusion over 1 hour on Day 1 of every 21-day cycle.	DOXIL+Docetaxel n=378 Participants DOXIL and docetaxel combination: DOXIL 30 mg/m2 solution administered by intravenous infusion, followed by docetaxel 60 mg/m2 administration by intravenous infusion over 1 hour on Day 1 of every 21-day cycle.	Total n=751 Participants Total of all reporting groups
Age, Continuous	52.0 years STANDARD_DEVIATION 9.23 • n=99 Participants	52.8 years STANDARD_DEVIATION 9.17 • n=107 Participants	52.4 years STANDARD_DEVIATION 9.20 • n=206 Participants
Sex: Female, Male Female	373 Participants n=99 Participants	378 Participants n=107 Participants	751 Participants n=206 Participants
Sex: Female, Male Male	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants

PRIMARY outcome

Timeframe: From date of randomization until date of disease progression or death, whichever occurred first, until approximately 485 events of disease progression or death were observed, as assessed approximately 15 months after the last patient was enrolled

Population: Intent to Treat: For patients who were progression free at the time of data cutoff, data were censored for time to progression at the time of their last tumor assessment.

Time interval in months between the date of randomization and the date of disease progression or death due to progression, whichever occurred first.

Outcome measures

Outcome measures
Measure	Docetaxel n=373 Participants Docetaxel monotherapy: Docetaxel 75 mg/m2 solution administered by intravenous infusion over 1 hour on Day 1 of every 21-day cycle.	DOXIL+Docetaxel n=378 Participants DOXIL and docetaxel combination: DOXIL 30 mg/m2 solution administered by intravenous infusion, followed by docetaxel 60 mg/m2 administration by intravenous infusion over 1 hour on Day 1 of every 21-day cycle.
Time to Progression	7.0 Months Interval 5.9 to 7.7	9.8 Months Interval 8.1 to 10.5

SECONDARY outcome

Timeframe: From the date of randomization until the participant's death from any cause, as assessed until approximately 485 death events were observed which is assessed approximately 25 months after the last patient was enrolled

Population: Intent to Treat: If the date of death was unknown, the data were censored at the date that the participant was last known to have been alive.

Time interval in months between the date of randomization and the participant's death from any cause.

Outcome measures

Outcome measures
Measure	Docetaxel n=373 Participants Docetaxel monotherapy: Docetaxel 75 mg/m2 solution administered by intravenous infusion over 1 hour on Day 1 of every 21-day cycle.	DOXIL+Docetaxel n=378 Participants DOXIL and docetaxel combination: DOXIL 30 mg/m2 solution administered by intravenous infusion, followed by docetaxel 60 mg/m2 administration by intravenous infusion over 1 hour on Day 1 of every 21-day cycle.
Overall Survival	20.7 Months Interval 18.3 to 26.3	20.4 Months Interval 19.0 to 23.1

SECONDARY outcome

Timeframe: Up to 30 to 42 days after last dose of study medication

Population: Evaluable population: Included all randomized participants who received at least 1 dose of study medication (DOXIL or docetaxel), and who had at least 1 postbaseline tumor assessment.

Number of participants in the evaluable population who achieved a CR or PR as per Response Evaluation Criteria In Solid Tumors (RECIST) criteria. CR: Disappearance of all target lesions and PR: at least a 30% decrease in the sum of longest diameter (LD) of target lesions taking as reference the baseline sum LD. Response was assessed by Computed Tomography (CT)/Magnetic Resonance Imaging (MRI).

Outcome measures

Outcome measures
Measure	Docetaxel n=364 Participants Docetaxel monotherapy: Docetaxel 75 mg/m2 solution administered by intravenous infusion over 1 hour on Day 1 of every 21-day cycle.	DOXIL+Docetaxel n=370 Participants DOXIL and docetaxel combination: DOXIL 30 mg/m2 solution administered by intravenous infusion, followed by docetaxel 60 mg/m2 administration by intravenous infusion over 1 hour on Day 1 of every 21-day cycle.
Response Rate: Number of Participants in the Evaluable Population Who Achieved a Complete Response (CR) or Partial Response (PR)	95 Participants	129 Participants

Adverse Events

Docetaxel

Serious events: 59 serious events

Other events: 340 other events

Deaths: 0 deaths

DOXIL+Docetaxel

Serious events: 69 serious events

Other events: 359 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Additional Information

Director Medical Leader

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Phone: 908 218 7361

Results disclosure agreements

Principal investigator is a sponsor employee If an investigator wishes to publish information from the study, a copy of the manuscript must be provided to the sponsor for review at least 60 days before submission. Expedited reviews will be arranged if needed. If requested by the sponsor in writing, the investigator will withhold such publication for up to an additional 60 days to allow for filing of a patent application. The sponsor will not mandate modifications to scientific content and does not have the right to suppress information.
Publication restrictions are in place

Restriction type: OTHER