Temozolomide as a Prophylaxis Against Brain Recurrence in Participants With Metastatic Breast Cancer (P05225 AM2) (STOP)

This study has been terminated.

(Terminated due to poor accrual)

Sponsor:

Information provided by:

Schering-Plough

ClinicalTrials.gov Identifier:

NCT00638963

First received: January 10, 2008

Last updated: June 23, 2011

Last verified: June 2011

History of Changes

Results First Received: June 23, 2011

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Efficacy Study; Intervention Model: Parallel Assignment; Masking: Open Label; Primary Purpose: Prevention
Conditions:	Breast Neoplasm Brain Neoplasm Second Neoplasm
Intervention:	Drug: temozolomide

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups

	Description
Temozolomide	Capsules to equal 75 mg/m^2, orally, daily for 6 weeks, in 3 eight-week cycles
Observational	No temozolomide treatment

Participant Flow: Overall Study

	Temozolomide	Observational
STARTED	3 ^[1]	3 ^[1]
COMPLETED	2 ^[2]	3 ^[2]
NOT COMPLETED	1	0
Withdrawal by Subject	1	0

[1]	Received randomized treatment assignment
[2]	including follow-up at Week 38 & Week 52

Baseline Characteristics

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Reporting Groups

	Description
Temozolomide	Capsules to equal 75 mg/m^2, orally, daily for 6 weeks, in 3 eight-week cycles
Observational	No temozolomide treatment
Total	Total of all reporting groups

Baseline Measures

	Temozolomide	Observational	Total
Number of Participants [units: participants]	3	3	6
Age [units: participants]
<=18 years	0	0	0
Between 18 and 65 years	3	3	6
>=65 years	0	0	0
Gender [units: participants]
Female	3	3	6
Male	0	0	0
Region of Enrollment [units: participants]
Italy	3	3	6

Outcome Measures

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1. Primary:

Percent of Participants With Recurrence of Brain Metastases [ Time Frame: 1 Year ]

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2. Secondary:

Number of Days With Progression-free Survival (PFS) [ Time Frame: 24, 38, and 52 weeks ]

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3. Secondary:

Number of Days With Disease-free Survival (DFS) [ Time Frame: 24, 38, and 52 weeks ]

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4. Secondary:

Number of Days With Distant Disease-free Survival (DDFS) [ Time Frame: 24, 38, and 52 weeks ]

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5. Secondary:

Number of Days With Brain Recurrence-free Survival (BRFS) [ Time Frame: 24,38, and 52 weeks ]

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6. Secondary:

Number of Days on Temozolomide Treatment [ Time Frame: Baseline to 24 Weeks ]

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Measure Type	Secondary
Measure Title	Number of Days on Temozolomide Treatment
Measure Description	This outcome measure was only applicable to the temozolomide arm; the observation arm was therefore not analyzed.
Time Frame	Baseline to 24 Weeks
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups

	Description
Temozolomide	Capsules to equal 75 mg/m^2, orally, daily for 6 weeks, in 3 eight-week cycles

Measured Values

	Temozolomide
Number of Participants Analyzed [units: participants]	3
Number of Days on Temozolomide Treatment [units: Days] Mean ± Standard Deviation	75 ± 65.82

No statistical analysis provided for Number of Days on Temozolomide Treatment

7. Secondary:

Total Dose of Temozolomide Taken [ Time Frame: Baseline to 24 Weeks ]

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8. Secondary:

Number of Participants Who Had at Least One Dose Reduction During Treatment [ Time Frame: Baseline to 24 Weeks ]

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9. Secondary:

Number of Participants Who Had at Least One Treatment Omission During Treatment [ Time Frame: Baseline to 24 Weeks ]

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10. Secondary:

Number of Participants Who Completed the Third Cycle of Treatment [ Time Frame: Baseline to 24 Weeks ]

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Serious Adverse Events

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Other Adverse Events

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More Information

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Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: The principal investigator (PI) agrees not to publish or publicly present any interim results of the Study without prior written consent of the sponsor. The PI further agrees to provide 45 days written notice to the sponsor prior to submission for publication or presentation to permit the sponsor to review copies of abstracts or manuscripts for publication in accordance with provisions of laws related to protection of sensitive personal data and patentability of inventions.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
The primary outcome measure and the survival analyses could not be analyzed due to the low enrollment.

Results Point of Contact:

Name/Title: Vice President, Late Stage Development Group Leader
Organization: Merck Sharp & Dohme Corp
e-mail: ClinicalTrialsDisclosure@merck.com

No publications provided

Responsible Party:	Vice President, Late Stage Development Group Leader, Merck Sharp & Dohme Corp
ClinicalTrials.gov Identifier:	NCT00638963 History of Changes
Other Study ID Numbers:	P05225, 2007-005491-14
Study First Received:	January 10, 2008
Results First Received:	June 23, 2011
Last Updated:	June 23, 2011
Health Authority:	Italy: Ministry of Health

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