Trial · NCT00382070
Letrozole in Treating Postmenopausal Women Who Have Received Hormone Therapy for Hormone Receptor-Positive Breast Cancer
NCT00382070, Phase 3, Unknown, NSABP Foundation Inc; results first posted 2021-05-20
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Letrozole in Treating Postmenopausal Women Who Have Received Hormone Therapy for Hormone Receptor-Positive Breast Cancer. Trials, record NCT00382070. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00382070
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Letrozole in Treating Postmenopausal Women Who Have Received Hormone Therapy for Hormone Receptor-Positive Breast Cancer
- NCT number
- NCT00382070
- Status
- Unknown
- Phases
- Phase 3
- Enrollment
- 3,966 participants, actual
- Lead sponsor
- NSABP Foundation Inc
- Conditions
- Breast Cancer
- Interventions
- Letrozole, Placebo
- First posted
- 2006-09-28
- Last updated
- 2024-03-22
- Results first posted
- 2021-05-20
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Disease-free Survival | 7 years. | Percentage of patients free from DFS events. DFS events include local, regional, or distant recurrence, second primary cancer or death from any cause prior to recurrence or second primary cancer. |
| Secondary | Overall Survival | 7 years | Percentage of patients alive |
| Secondary | Breast Cancer-free Interval | 7 years | Cumulative incidence of breast-cancer-free interval events. BCFI events include local-regional recurrence, distant recurrence or contralateral breast cancer as a first event. |
| Secondary | Distant Recurrence | 7 years | Cumulative incidence of distant recurrences. |
| Secondary | Osteoporotic-related Fractures | 7 years | Cumulative incidence of osteoporotic-related fractures defined as Colles', hip or spinal fractures |
| Secondary | Arterial Thrombotic Events | 7 years | Cumulative incidence of arterial thrombotic events, as defined by CTCAE version 4.0 (grade ≥1 stroke or transient ischaemic attack; grade ≥2 acute coronary syndrome or cerebrovascular ischaemia; grade ≥3 myocardial infarction, peripheral ischaemia, or visceral arterial ischaemia; and grade ≥4 selected thromboembolic events \[cerebrovascular event, arterial insufficiency\]). |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Disease-free Survival | 7 years. | percentage of patients free of disease | NUMBER | |
| SECONDARY | Overall Survival | 7 years | Patients with any type of follow up. | percentage of patients alive | NUMBER |
| SECONDARY | Breast Cancer-free Interval | 7 years | percentage of patients | NUMBER | |
| SECONDARY | Distant Recurrence | 7 years | percentage of patients | NUMBER | |
| SECONDARY | Osteoporotic-related Fractures | 7 years | percentage of patients | NUMBER | |
| SECONDARY | Arterial Thrombotic Events | 7 years | percentage of patients | NUMBER |
Source ClinicalTrials.gov
Results by group12
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Disease-free Survival | Group 2 Letrozole | 84.7 | percentage of patients free of disease | ||
| Disease-free Survival | Group 1 Placebo | 81.3 | percentage of patients free of disease | ||
| Overall Survival | Group 2 Letrozole | 91.8 | percentage of patients alive | ||
| Overall Survival | Group 1 Placebo | 92.3 | percentage of patients alive | ||
| Breast Cancer-free Interval | Group 2 Letrozole | 6.7 | percentage of patients | ||
| Breast Cancer-free Interval | Group 1 Placebo | 10 | percentage of patients | ||
| Distant Recurrence | Group 2 Letrozole | 3.9 | percentage of patients | ||
| Distant Recurrence | Group 1 Placebo | 5.8 | percentage of patients | ||
| Osteoporotic-related Fractures | Group 2 Letrozole | 5.4 | percentage of patients | ||
| Osteoporotic-related Fractures | Group 1 Placebo | 4.8 | percentage of patients |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Group 2 Letrozole | 1,983 | |
| Overall Study | STARTED | Group 1 Placebo | 1,983 | |
| Overall Study | COMPLETED | Group 2 Letrozole | 1,950 | |
| Overall Study | COMPLETED | Group 1 Placebo | 1,953 | |
| Overall Study | NOT COMPLETED | Group 2 Letrozole | 33 | |
| Overall Study | NOT COMPLETED | Group 1 Placebo | 30 |
Source ClinicalTrials.gov
Adverse events162
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 | Events |
|---|---|---|---|---|---|---|
| other | Arthralgia | Musculoskeletal and connective tissue disorders | Placebo | 302 | 1,938 | |
| other | Arthralgia | Musculoskeletal and connective tissue disorders | Letrozole | 347 | 1,951 | |
| other | Myalgia | Musculoskeletal and connective tissue disorders | Placebo | 118 | 1,938 | |
| other | Myalgia | Musculoskeletal and connective tissue disorders | Letrozole | 149 | 1,951 | |
| serious | Adult respiratory distress syndrome | Respiratory, thoracic and mediastinal disorders | Placebo | 1 | 1,938 | |
| serious | Adult respiratory distress syndrome | Respiratory, thoracic and mediastinal disorders | Letrozole | 0 | 1,951 | |
| serious | Alanine aminotransferase increased (ALT/SGPT) | Investigations | Placebo | 1 | 1,938 | |
| serious | Alanine aminotransferase increased (ALT/SGPT) | Investigations | Letrozole | 2 | 1,951 | |
| serious | Amnesia | Nervous system disorders | Placebo | 1 | 1,938 | |
| serious | Amnesia | Nervous system disorders | Letrozole | 0 | 1,951 |
1 to 10 of 162Source ClinicalTrials.gov
See all 162 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo | ||
| Total, all-cause mortality | Letrozole | ||
| Total, other adverse events | Placebo | 336 | 1,938 |
| Total, other adverse events | Letrozole | 400 | 1,951 |
| Total, serious adverse events | Placebo | 87 | 1,938 |
| Total, serious adverse events | Letrozole | 80 | 1,951 |
Source ClinicalTrials.gov
Papers3
The papers the trial lists on ClinicalTrials.gov.
Grants1
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.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| U10CA012027 | NATIONAL SURGICAL ADJUVANT BREAST AND BOWEL PROJECT | WOLMARK, NORMAN | NSABP FOUNDATION, INC. | NATIONAL CANCER INSTITUTE | 1985 to 2012 |
Source NIH RePORTER
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Letrozole vs Placebo: serious adverse events |
Source 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.
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/NCT00382070
GET https://conductscience.org/api/trials/v1/NCT00382070/events?page=2