18F-FLT-PET in Breast Cancer (MK-0000-139 AM1)

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Merck

ClinicalTrials.gov Identifier:

NCT01015131

First received: November 17, 2009

Last updated: December 17, 2012

Last verified: December 2012

History of Changes

Results First Received: November 6, 2012

Study Type:	Interventional
Study Design:	Endpoint Classification: Pharmacodynamics Study; Intervention Model: Single Group Assignment; Masking: Open Label; Primary Purpose: Diagnostic
Condition:	Breast Cancer
Intervention:	Radiation: 18F-FLT-PET/CT Imaging

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
After enrollment, 2 of the 46 participants discontinued due to lack of available 3'-deoxy-3'[18F]-fluorothymidine (18-FLT), leaving 44 participants as the baseline population.

Reporting Groups

	Description
All Participants	Participants who underwent 18-FLT positron emission tomography (PET) and standard of care (SOC) neo-adjuvant chemotherapy

Participant Flow: Overall Study

	All Participants
STARTED	44
COMPLETED	36
NOT COMPLETED	8
Physician Decision	1
Protocol Violation	1
Withdrawal by Subject	2
Other Protocol Specified Criteria	4

Baseline Characteristics

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Reporting Groups

	Description
All Participants	Participants who underwent 18-FLT positron emission tomography (PET) and standard of care (SOC) neo-adjuvant chemotherapy

Baseline Measures

	All Participants
Number of Participants [units: participants]	44
Age [units: years] Mean ± Standard Deviation	50.0 ± 9.0
Gender [units: participants]
Female	44
Male	0

Outcome Measures

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1. Primary:

Change From Baseline in 18F-FLT-PET Mean Standardized Uptake Value (SUVmean) After the First Cycle of Standard of Care (SOC) Neo-adjuvant Chemotherapy. [ Time Frame: Baseline and up to 3 weeks ]

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2. Primary:

Change From Baseline in 18F-FLT-PET Maximum Standardized Uptake Value (SUVmax) After the First Cycle of SOC Neo-adjuvant Chemotherapy. [ Time Frame: Baseline and up to 3 weeks ]

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3. Primary:

Change From Baseline in Ki-67 Labeling Index After the First Cycle of SOC Neo-adjuvant Chemotherapy. [ Time Frame: Baseline and up to 3 weeks ]

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4. Primary:

Spearman's Rank Correlation Coefficient Between Change From Baseline in Ki-67 Labeling Index and Change From Baseline in SUVmean After the First Cycle of SOC Neo-adjuvant Chemotherapy. [ Time Frame: Baseline and up to 3 weeks ]

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5. Primary:

Spearman's Rank Correlation Coefficient Between Change From Baseline in Ki-67 Labeling Index and Change From Baseline in SUVmax After the First Cycle of SOC Neo-adjuvant Chemotherapy. [ Time Frame: Baseline and up to 3 weeks ]

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6. Secondary:

Change From Baseline in Proliferation Signature Score (PSS) After the First Cycle of SOC Neo-adjuvant Chemotherapy. [ Time Frame: Baseline and up to 3 weeks ]

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7. Secondary:

Change From Baseline in Tumor Volume at the End of SOC Neo-adjuvant Chemotherapy. [ Time Frame: Baseline and up to 30 weeks ]

Show Outcome Measure 7

8. Secondary:

Spearman's Rank Correlation Coefficient Between Change From Baseline in PSS After the First Cycle of SOC Neo-adjuvant Chemotherapy, and Change From Baseline in Tumor Volume at the End of SOC Neo-adjuvant Chemotherapy. [ Time Frame: Baseline and up to 30 weeks ]

Show Outcome Measure 8

9. Secondary:

Spearman's Rank Correlation Coefficient Between Change From Baseline in Ki-67 LI After the First Cycle of SOC Neo-adjuvant Chemotherapy, and Change From Baseline in Tumor Volume at the End of SOC Neo-adjuvant Chemotherapy. [ Time Frame: Baseline and up to 30 weeks ]

Show Outcome Measure 9

10. Secondary:

Spearman's Rank Correlation Coefficient Between Change From Baseline in SUVmax After the First Cycle of SOC Neo-adjuvant Chemotherapy, and Change From Baseline in Tumor Volume at the End of SOC Neo-adjuvant Chemotherapy. [ Time Frame: Baseline and up to 30 weeks ]

Show Outcome Measure 10

11. Secondary:

Spearman's Rank Correlation Coefficient Between Change From Baseline in SUVmean After the First Cycle of SOC Neo-adjuvant Chemotherapy, and Change From Baseline in Tumor Volume at the End of SOC Neo-adjuvant Chemotherapy. [ Time Frame: Baseline and up to 30 weeks ]

Show Outcome Measure 11

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 SPONSOR must have the opportunity to review all proposed abstracts, manuscripts, or presentations regarding this study 60 days prior to submission for publication/presentation. Any information identified by the SPONSOR as confidential must be deleted prior to submission.

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
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Results Point of Contact:

Name/Title: Vice President, Late Stage Development Group Leader
Organization: Merck Sharp & Dohme Corp
phone: 1-800-672-6372
e-mail: ClinicalTrialsDisclosure@merck.com

No publications provided

Responsible Party:	Merck
ClinicalTrials.gov Identifier:	NCT01015131 History of Changes
Other Study ID Numbers:	MK-0000-139, 2009_692
Study First Received:	November 17, 2009
Results First Received:	November 6, 2012
Last Updated:	December 17, 2012
Health Authority:	United States: Food and Drug Administration

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