Trial · NCT00754845

Letrozole in Breast Cancer Who Have Received 5 Years of Aromatase Inhibitor Therapy

NCT00754845, Phase 3, Completed, Canadian Cancer Trials Group; results first posted 2018-11-19

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Letrozole in Breast Cancer Who Have Received 5 Years of Aromatase Inhibitor Therapy. Trials, record NCT00754845. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00754845

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Letrozole in Breast Cancer Who Have Received 5 Years of Aromatase Inhibitor Therapy
NCT number: NCT00754845
Status: Completed
Phases: Phase 3
Enrollment: 1,918 participants, actual
Lead sponsor: Canadian Cancer Trials Group
Conditions: Breast Cancer
Interventions: letrozole, placebo
First posted: 2008-09-18
Last updated: 2023-08-25
Results first posted: 2018-11-19

Source ClinicalTrials.gov

Registered outcomes4

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Disease-free Survival (DFS)	Unitil the end of study with a median follow up of 75 months	It is defined as the months from the day of randomization to the earliest date when a recurrence of the primary disease (recurrence in the breast, chest wall and nodal sites or the development of metastatic disease) or a contralateral breast cancer was observed. Subjects who died without recurrence of the primary disease or the development of the contralateral breast cancer were censored at their death date. If a patient has not recurred, developed a contralateral breast cancer, or died, disease-free survival was censored on the date of the last day the patient was known to be alive. Probability of disease free survival at 5 years is estimated and reported.
Secondary	Incidence of Contralateral Breast Cancer	10 years	The annual incidence rate was estimated based on the time to the development of contralateral breast cancer, which was calculated in months from the day of randomization to the diagnosis date of contralateral breast cancer for subjects who had developed the contralateral breast cancer, to the time of death for the patient who died, or to the last day the patient was known alive for subjects without contralateral breast cancer
Secondary	Overall Survival (OS)	Until the end of study with a median follow-up of 75 months	For subjects who died, overall survival was calculated in months from the day of randomization to the date of death. Otherwise, survival was censored at the last day the patient was known to be alive. Probability of overall survival at 5 years is estimated and reported.
Secondary	Change From Baseline in Role Function- Physical Scale on SF(Short Form)-36 Health Survey	8 years	Difference between post baseline scores and baseline score of role function-physical scale on SF-36 Health Survey (scale range between 0 and 100 with higher score indicating better quality of life).

Source ClinicalTrials.gov

Outcomes4

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Disease-free Survival (DFS)	Unitil the end of study with a median follow up of 75 months	All women randomized were included in the analysis based on treatment arm they were randomized.	probability of DFS at 5 years	NUMBER
SECONDARY	Incidence of Contralateral Breast Cancer	10 years	All women randomized	Number of new case per 1000 person years	NUMBER
SECONDARY	Overall Survival (OS)	Until the end of study with a median follow-up of 75 months	All women randomized	probability of OS at 5 years	NUMBER
SECONDARY	Change From Baseline in Role Function- Physical Scale on SF(Short Form)-36 Health Survey	8 years	All randomized patients.	score on a scale	LEAST_SQUARES_MEAN

Source ClinicalTrials.gov

Results by group8

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Disease-free Survival (DFS)	Letrozole	0.95	95% Confidence Interval 0.93 to 0.96	probability of DFS at 5 years
Disease-free Survival (DFS)	Placebo	0.91	95% Confidence Interval 0.89 to 0.93	probability of DFS at 5 years
Incidence of Contralateral Breast Cancer	Letrozole	2.1	95% Confidence Interval 1.0 to 3.2	Number of new case per 1000 person years
Incidence of Contralateral Breast Cancer	Placebo	4.9	95% Confidence Interval 3.2 to 6.7	Number of new case per 1000 person years
Overall Survival (OS)	Arm I	0.93	95% Confidence Interval 0.92 to 0.95	probability of OS at 5 years
Overall Survival (OS)	Arm II	0.94	95% Confidence Interval 0.92 to 0.95	probability of OS at 5 years
Change From Baseline in Role Function- Physical Scale on SF(Short Form)-36 Health Survey	Letrozole	-7.74	Standard Error 1.09	score on a scale
Change From Baseline in Role Function- Physical Scale on SF(Short Form)-36 Health Survey	Placebo	-6.28	Standard Error 1.08	score on a scale

Source ClinicalTrials.gov

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Letrozole	959
Overall Study	STARTED	Placebo	959
Overall Study	COMPLETED	Letrozole	959
Overall Study	COMPLETED	Placebo	959
Overall Study	NOT COMPLETED	Letrozole	0
Overall Study	NOT COMPLETED	Placebo	0

Source ClinicalTrials.gov

Adverse events114

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Edema	Cardiac disorders	Arm I	158	959
other	Edema	Cardiac disorders	Arm II	136	954
other	Hypertension	Cardiac disorders	Arm I	157	959
other	Hypertension	Cardiac disorders	Arm II	145	954
other	Hot flashes/ flushes	Endocrine disorders	Arm I	360	959
other	Hot flashes/ flushes	Endocrine disorders	Arm II	354	954
other	Fatigue	General disorders	Arm I	346	959
other	Fatigue	General disorders	Arm II	355	954
other	Sweating	General disorders	Arm I	176	959
other	Sweating	General disorders	Arm II	175	954

1 to 10 of 114Source ClinicalTrials.gov

See all 114 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Arm I	100	959
Total, all-cause mortality	Arm II	100	954
Total, other adverse events	Arm I	863	959
Total, other adverse events	Arm II	841	954
Total, serious adverse events	Arm I	15	959
Total, serious adverse events	Arm II	19	954

Source ClinicalTrials.gov

Papers4

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
27264120	RESULT	PubMed
29328860	DERIVED	PubMed
33853037	DERIVED	PubMed
34825307	DERIVED	PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons2

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
Arm I vs Arm II: deaths from any cause	Trial comparisons
Arm I vs Arm II: serious adverse events	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT00754845

GET https://conductscience.org/api/trials/v1/NCT00754845/events?page=2

API reference For AI assistants