Safety/Efficacy of Letrozole Monotherapy or in Combination With Zoledronic Acid as Extended Adjuvant Treatment of Postmenopausal Patients With Primary Breast Cancer

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Novartis

ClinicalTrials.gov Identifier:

NCT00332709

First received: May 31, 2006

Last updated: October 10, 2011

Last verified: October 2011

History of Changes

Results First Received: August 11, 2011

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Open Label; Primary Purpose: Treatment
Conditions:	Osteoporosis Postmenopausal
Interventions:	Drug: Letrozole Drug: Zoledronic acid

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
Total Randomized participants were 83. 2 patients were enrolled but never received study medication. Hence, 81 were included in the safety population.

Reporting Groups

	Description
Letrozole	Letrozole 2.5 mg/day for 3 years
Letrozole + Zoledronic Acid	Letrozole 2.5mg/day for 3 years plus Zoledronic acid 4mg every 6 months

Participant Flow: Overall Study

	Letrozole	Letrozole + Zoledronic Acid
STARTED	40	41
COMPLETED	24	21
NOT COMPLETED	16	20
Adverse Event	11	14
Withdrawal by Subject	2	3
Lost to Follow-up	2	0
Administrative Problems	0	3
Abnormal test procedure result	1	0

Baseline Characteristics

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Reporting Groups

	Description
Letrozole	Letrozole 2.5 mg/day for 3 years
Letrozole + Zoledronic Acid	Letrozole 2.5mg/day for 3 years plus Zoledronic acid 4mg every 6 months
Total	Total of all reporting groups

Baseline Measures

	Letrozole	Letrozole + Zoledronic Acid	Total
Number of Participants [units: participants]	37	39	76
Age ^[1] [units: participants]
<=18 years	0	0	0
Between 18 and 65 years	37	39	76
>=65 years	0	0	0
Age [units: years] Mean ± Standard Deviation	61.3 ± 7.3	58.4 ± 7.3	59.8 ± 7.4
Gender [units: participants]
Female	37	39	76
Male	0	0	0

[1]	Demographic data is provided for the Intent to Treat population.

Outcome Measures

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1. Primary:

Change in Bone Mineral Density (BMD) From Baseline to Month 36 [ Time Frame: at 36 months as compared to baseline ]

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2. Primary:

Percent Change in Bone Mineral Density (BMD) From Baseline to Month 36 [ Time Frame: Baseline, Month 36 ]

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3. Primary:

Change in T-score From Baseline to Month 36 [ Time Frame: Baseline and Month 36 ]

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Measure Type	Primary
Measure Title	Change in T-score From Baseline to Month 36
Measure Description	BMD measured by DXA (dual energy x-ray absorptiometry) at lumbar spine, L1-L4. The T-Score is a comparison of a patient's BMD to that of a healthy 30 year of the same sex and ethnicity. The criteria of the World Health Organization are Normal is a T-Score of 1.0 or higher. Osteopenia is defined as between - 1.0 and -2.5. Osteoporosis is defined as -2.5 or lower, meaning a bone density that is two and half standard deviations below the mean of a 30 year old man/woman.
Time Frame	Baseline and Month 36
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.
(ITT) The study population will consist of post menopausal breast cancer patients who have completed 4 to 6 years of adjuvant Tamoxifen therapy after therapy.Participants with observations at both baseline and endpoint were included in the analysis.

Reporting Groups

	Description
Letrozole	Letrozole 2.5 mg/day for 3 years
Letrozole + Zoledronic Acid	Letrozole 2.5mg/day for 3 years plus Zoledronic acid 4mg every 6 months

Measured Values

	Letrozole	Letrozole + Zoledronic Acid
Number of Participants Analyzed [units: participants]	20	21
Change in T-score From Baseline to Month 36 [units: T-Score] Mean ± Standard Deviation	-0.90 ± 1.03	0.46 ± 0.27

No statistical analysis provided for Change in T-score From Baseline to Month 36

4. Primary:

Change in Z Score From Baseline to Month 36 [ Time Frame: Baseline, month 36 ]

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5. Secondary:

Change in Bone Mineral Density From Baseline to 12 Months [ Time Frame: Baseline, 12 months ]

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6. Secondary:

Number of Participants With Any Kind of Fractures, by Visit. [ Time Frame: Baseline, Month 6, 12, 18, 24 , 30 and 36 ]

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7. Secondary:

Median Disease Free Survival (DFS) [ Time Frame: 36 months ]

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8. Secondary:

Change in T-Score From Baseline to Month 12 [ Time Frame: Baseline, Month 12 ]

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9. Secondary:

Change in Z-Score From Baseline to Month 12 [ Time Frame: Baseline, Month 12 ]

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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 terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial; or disclosure of the trial results in their entirety.

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
No text entered.

Results Point of Contact:

Name/Title: Study Director
Organization: Novartis Pharmaceuticals
phone: 862-778-8300

No publications provided

Responsible Party:	Novartis
ClinicalTrials.gov Identifier:	NCT00332709 History of Changes
Other Study ID Numbers:	CFEM345DDE09
Study First Received:	May 31, 2006
Results First Received:	August 11, 2011
Last Updated:	October 10, 2011
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

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