Open-Label Study Of Exemestane With Or Without Celecoxib In Postmenopausal Women With ABC Having Progressed On Tamoxifen

This study has been completed.

Study NCT00038103 Information provided by Pfizer

First Received on May 29, 2002. Last Updated on February 11, 2010 History of Changes

Results First Received: March 27, 2009

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Open Label; Primary Purpose: Treatment
Condition:	Breast Neoplasms
Interventions:	Drug: Exemestane Drug: Celecoxib + Exemestane

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
2 subjects in the exemestane arm were never treated. One subject refused to be treated having originally consented to participate in this study and the other, reason for not starting treatment was unknown

Reporting Groups

	Description
Exemestane (Exemestane Alone)	oral dose exemestane taken with food (25 mg tablet once daily)
Combination (Exemestane + Celecoxib)	oral doses to be taken with food (25 mg tablet exemestane once daily; celecoxib 2 x 200 mg tablets twice daily)

Participant Flow: Overall Study

	Exemestane (Exemestane Alone)	Combination (Exemestane + Celecoxib)
STARTED	55	56
End of Treatment	53 ^[1]	56 ^[1]
COMPLETED	0	0
NOT COMPLETED	55	56
Adverse Event	5	6
Lack of Efficacy	48	41
Withdrawal by Subject	0	3
Lost to Follow-up	0	3
Protocol Violation	0	2
Sponsor Decision	0	1
Randomized/never treated	2	0

[1]	patients remained on treatment until discontinued

Baseline Characteristics

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Reporting Groups

	Description
Exemestane (Exemestane Alone)	oral dose exemestane taken with food (25 mg tablet once daily)
Combination (Exemestane + Celecoxib)	oral doses to be taken with food (25 mg tablet exemestane once daily; celecoxib 2 x 200 mg tablets twice daily)

Baseline Measures

	Exemestane (Exemestane Alone)	Combination (Exemestane + Celecoxib)	Total
Number of Participants [units: participants]	55	56	111
Age, Customized [units: Participants]
< 50 years	20.0	16.0	36.0
50-64 years	20.0	27.0	47.0
65-79 years	15.0	12.0	27.0
=> 80 years	0.0	1.0	1.0
Gender ^[1] [units: participants]
Female	55	56	111
Male	0	0	0

[1]	All participants were female

Outcome Measures

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1. Primary:

Number of Subjects With Clinical Benefit [ Time Frame: Baseline, Week 8, 16, 24, and every 12 weeks beyond 24 up to Week 108 and every 24 weeks thereafter until 9 months following last subject last visit (LSLV) ]

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2. Secondary:

Number of Subjects With Objective Response [ Time Frame: Baseline, Weeks 8, 16, 24, every 12 weeks from Week 24 up to Week 108, and every 24 weeks thereafter until 9 months following LSLV ]

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3. Secondary:

Duration of Clinical Benefit [ Time Frame: Baseline, Weeks 8, 16, 24, every 12 weeks from Week 24 up to Week 108, and every 24 weeks thereafter until 9 months following LSLV ]

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4. Secondary:

Duration of Objective Response (in Subjects With CR or PR) [ Time Frame: Baseline, Weeks 8, 16, 24, every 12 weeks beyond 24 up to Week 108, and every 24 weeks thereafter until 9 months following LSLV ]

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5. Secondary:

Duration of Long-Term SD [ Time Frame: Baseline, Weeks 8, 16, 24, every 12 weeks from Week 24 up to Week 108, and every 24 weeks thereafter until 9 months LSLV ]

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6. Secondary:

Time to Tumor Progression [ Time Frame: Baseline, Weeks 8, 16, 24, every 12 weeks beyond Week 24 up to Week 108 and every 24 weeks thereafter until 9 months following LSLV ]

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7. Secondary:

Time to Treatment Failure [ Time Frame: Baseline, Weeks 8, 16, 24, every 12 weeks from Week 24 up to Week 108, and every 24 weeks thereafter until 9 months following LSLV ]

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8. Secondary:

Survival [ Time Frame: Baseline, Weeks 8, 16, 24, every 12 weeks from Week 24 up to Week 108, and every 24 weeks thereafter until 9 months following LSLV or death ]

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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: Pfizer has the right to review disclosures, requesting a delay of < 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), < 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential info other than study results.

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: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
phone: 1-800-718-1021
e-mail: ClinicalTrials.govCallCenter@pfizer.com

No publications provided

Responsible Party:	Director, Clinical Trial Disclosure Group, Pfizer Inc
ClinicalTrials.gov Identifier:	NCT00038103 History of Changes
Other Study ID Numbers:	NQ8-01-02-013, A3191139
Study First Received:	May 29, 2002
Results First Received:	March 27, 2009
Last Updated:	February 11, 2010
Health Authority:	United States: Food and Drug Administration