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Letrozole in Treating Postmenopausal Women Who Have Received Hormone Therapy for Hormone Receptor-Positive Breast Cancer

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ClinicalTrials.gov Identifier: NCT00382070
Recruitment Status : Active, not recruiting
First Posted : September 28, 2006
Results First Posted : May 20, 2021
Last Update Posted : May 20, 2021
Sponsor:
Collaborators:
National Cancer Institute (NCI)
Novartis
Information provided by (Responsible Party):
NSABP Foundation Inc

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Breast Cancer
Interventions Drug: Letrozole
Other: Placebo
Enrollment 3966
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Group 2 Letrozole Group 1 Placebo
Hide Arm/Group Description

Patients receive oral letrozole once daily for up to 5 years.

Letrozole: Letrozole 2.5 mg taken orally once daily for 5 years

Patients receive oral placebo once daily for up to 5 years.

Placebo: Placebo tablet taken orally once daily for 5 years

Period Title: Overall Study
Started 1983 1983
Completed 1950 1953
Not Completed 33 30
Reason Not Completed
No follow up data mapped to Other             17             19
Patient not at risk for primary endpoint mapped to Other             7             0
No clinical assessment             9             11
Arm/Group Title Placebo Letrozole Total
Hide Arm/Group Description Placebo Letrozole Total of all reporting groups
Overall Number of Baseline Participants 1983 1983 3966
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 1983 participants 1983 participants 3966 participants
63  (8.4) 63  (8.7) 63  (8.6)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1983 participants 1983 participants 3966 participants
Female
1983
 100.0%
1983
 100.0%
3966
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
1.Primary Outcome
Title Disease-free Survival
Hide Description 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.
Time Frame 7 years.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Group 2 Letrozole Group 1 Placebo
Hide Arm/Group Description:

Patients receive oral letrozole once daily for up to 5 years.

Letrozole: Letrozole 2.5 mg taken orally once daily for 5 years

Patients receive oral placebo once daily for up to 5 years.

Placebo: Placebo tablet taken orally once daily for 5 years

Overall Number of Participants Analyzed 1950 1953
Measure Type: Number
Unit of Measure: percentage of patients free of disease
84.7 81.3
2.Secondary Outcome
Title Overall Survival
Hide Description Percentage of patients alive
Time Frame 7 years
Hide Outcome Measure Data
Hide Analysis Population Description
Patients with any type of follow up.
Arm/Group Title Group 2 Letrozole Group 1 Placebo
Hide Arm/Group Description:

Patients receive oral letrozole once daily for up to 5 years.

Letrozole: Letrozole 2.5 mg taken orally once daily for 5 years

Patients receive oral placebo once daily for up to 5 years.

Placebo: Placebo tablet taken orally once daily for 5 years

Overall Number of Participants Analyzed 1959 1964
Measure Type: Number
Unit of Measure: percentage of patients alive
91.8 92.3
3.Secondary Outcome
Title Breast Cancer-free Interval
Hide Description Cumulative incidence of breast-cancer-free interval events. BCFI events include local-regional recurrence, distant recurrence or contralateral breast cancer as a first event.
Time Frame 7 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Group 2 Letrozole Group 1 Placebo
Hide Arm/Group Description:

Patients receive oral letrozole once daily for up to 5 years.

Letrozole: Letrozole 2.5 mg taken orally once daily for 5 years

Patients receive oral placebo once daily for up to 5 years.

Placebo: Placebo tablet taken orally once daily for 5 years

Overall Number of Participants Analyzed 1950 1953
Measure Type: Number
Unit of Measure: percentage of patients
6.7 10
4.Secondary Outcome
Title Distant Recurrence
Hide Description Cumulative incidence of distant recurrences.
Time Frame 7 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Group 2 Letrozole Group 1 Placebo
Hide Arm/Group Description:

Patients receive oral letrozole once daily for up to 5 years.

Letrozole: Letrozole 2.5 mg taken orally once daily for 5 years

Patients receive oral placebo once daily for up to 5 years.

Placebo: Placebo tablet taken orally once daily for 5 years

Overall Number of Participants Analyzed 1950 1953
Measure Type: Number
Unit of Measure: percentage of patients
3.9 5.8
5.Secondary Outcome
Title Osteoporotic-related Fractures
Hide Description Cumulative incidence of osteoporotic-related fractures defined as Colles', hip or spinal fractures
Time Frame 7 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Group 2 Letrozole Group 1 Placebo
Hide Arm/Group Description:

Patients receive oral letrozole once daily for up to 5 years.

Letrozole: Letrozole 2.5 mg taken orally once daily for 5 years

Patients receive oral placebo once daily for up to 5 years.

Placebo: Placebo tablet taken orally once daily for 5 years

Overall Number of Participants Analyzed 1950 1953
Measure Type: Number
Unit of Measure: percentage of patients
5.4 4.8
6.Secondary Outcome
Title Arterial Thrombotic Events
Hide Description 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]).
Time Frame 7 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Group 2 Letrozole Group 1 Placebo
Hide Arm/Group Description:

Patients receive oral letrozole once daily for up to 5 years.

Letrozole: Letrozole 2.5 mg taken orally once daily for 5 years

Patients receive oral placebo once daily for up to 5 years.

Placebo: Placebo tablet taken orally once daily for 5 years

Overall Number of Participants Analyzed 1950 1953
Measure Type: Number
Unit of Measure: percentage of patients
4.0 3.4
Time Frame [Not Specified]
Adverse Event Reporting Description Participants at Risk includes any patient who submitted an AE form.
 
Arm/Group Title Placebo Letrozole
Hide Arm/Group Description Placebo Letrozole
All-Cause Mortality
Placebo Letrozole
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Hide Serious Adverse Events
Placebo Letrozole
Affected / at Risk (%) Affected / at Risk (%)
Total   87/1938 (4.49%)   80/1951 (4.10%) 
Blood and lymphatic system disorders     
Anemia  1  5/1938 (0.26%)  2/1951 (0.10%) 
Cardiac disorders     
Atrial fibrillation  1  1/1938 (0.05%)  1/1951 (0.05%) 
Cardiac arrest  1  3/1938 (0.15%)  4/1951 (0.21%) 
Cardiac disorders - Other, specify  1  3/1938 (0.15%)  2/1951 (0.10%) 
Heart failure  1  2/1938 (0.10%)  5/1951 (0.26%) 
Myocardial infarction  1  9/1938 (0.46%)  4/1951 (0.21%) 
Pericardial effusion  1  1/1938 (0.05%)  1/1951 (0.05%) 
Ventricular fibrillation  1  0/1938 (0.00%)  1/1951 (0.05%) 
Acute coronary syndrome  1  0/1938 (0.00%)  1/1951 (0.05%) 
Right ventricular dysfunction  1  1/1938 (0.05%)  0/1951 (0.00%) 
Aortic valve disease  1  5/1938 (0.26%)  3/1951 (0.15%) 
Left ventricular systolic dysfunction  1  2/1938 (0.10%)  6/1951 (0.31%) 
Gastrointestinal disorders     
Rectal hemorrhage  1  1/1938 (0.05%)  0/1951 (0.00%) 
Small intestinal obstruction  1  1/1938 (0.05%)  0/1951 (0.00%) 
Upper gastrointestinal hemorrhage  1  0/1938 (0.00%)  1/1951 (0.05%) 
General disorders     
Death NOS  1  1/1938 (0.05%)  1/1951 (0.05%) 
Multi-organ failure  1  2/1938 (0.10%)  0/1951 (0.00%) 
Hepatobiliary disorders     
Hepatic failure  1  0/1938 (0.00%)  1/1951 (0.05%) 
Hepatobiliary disorders - Other, specify  1  0/1938 (0.00%)  1/1951 (0.05%) 
Infections and infestations     
Bladder infection  1  0/1938 (0.00%)  1/1951 (0.05%) 
Infections and infestations - Other, specify  1  1/1938 (0.05%)  0/1951 (0.00%) 
Sepsis  1  2/1938 (0.10%)  4/1951 (0.21%) 
Skin infection  1  0/1938 (0.00%)  1/1951 (0.05%) 
Urinary tract infection  1  2/1938 (0.10%)  4/1951 (0.21%) 
Wound infection  1  0/1938 (0.00%)  1/1951 (0.05%) 
Lung infection  1  6/1938 (0.31%)  0/1951 (0.00%) 
Injury, poisoning and procedural complications     
Aortic injury  1  1/1938 (0.05%)  0/1951 (0.00%) 
Fracture  1  0/1938 (0.00%)  2/1951 (0.10%) 
Injury, poisoning and procedural complications - Other, specify  1  0/1938 (0.00%)  1/1951 (0.05%) 
Tracheal obstruction  1  0/1938 (0.00%)  1/1951 (0.05%) 
Investigations     
Alanine aminotransferase increased (ALT/SGPT)  1  1/1938 (0.05%)  2/1951 (0.10%) 
Aspartate aminotransferase increased (AST/SGOT)  1  3/1938 (0.15%)  2/1951 (0.10%) 
Blood bilirubin increased  1  0/1938 (0.00%)  1/1951 (0.05%) 
Cardiac troponin I increased  1  2/1938 (0.10%)  1/1951 (0.05%) 
Cardiac troponin T increased  1  1/1938 (0.05%)  1/1951 (0.05%) 
Creatinine increased  1  1/1938 (0.05%)  1/1951 (0.05%) 
Lipase increased  1  0/1938 (0.00%)  2/1951 (0.10%) 
Neutrophil count decreased  1  0/1938 (0.00%)  1/1951 (0.05%) 
Platelet count decreased  1  1/1938 (0.05%)  1/1951 (0.05%) 
Serum amylase increased  1  0/1938 (0.00%)  1/1951 (0.05%) 
White blood cell decreased  1  0/1938 (0.00%)  1/1951 (0.05%) 
Metabolism and nutrition disorders     
Dehydration  1  2/1938 (0.10%)  0/1951 (0.00%) 
Hypercalcemia  1  2/1938 (0.10%)  2/1951 (0.10%) 
Hyperglycemia  1  0/1938 (0.00%)  2/1951 (0.10%) 
Hyperkalemia  1  1/1938 (0.05%)  2/1951 (0.10%) 
Hypertriglyceridemia  1  1/1938 (0.05%)  0/1951 (0.00%) 
Hyperuricemia  1  1/1938 (0.05%)  1/1951 (0.05%) 
Hypocalcemia  1  0/1938 (0.00%)  1/1951 (0.05%) 
Hypokalemia  1  0/1938 (0.00%)  4/1951 (0.21%) 
Hyponatremia  1  2/1938 (0.10%)  1/1951 (0.05%) 
Musculoskeletal and connective tissue disorders     
Soft tissue necrosis lower limb  1  0/1938 (0.00%)  1/1951 (0.05%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Myelodysplastic syndrome  1  4/1938 (0.21%)  2/1951 (0.10%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify  1  5/1938 (0.26%)  4/1951 (0.21%) 
Leukemia secondary to oncology chemotherapy  1  1/1938 (0.05%)  3/1951 (0.15%) 
Treatment related secondary malignancy  1  0/1938 (0.00%)  2/1951 (0.10%) 
Nervous system disorders     
Amnesia  1  1/1938 (0.05%)  0/1951 (0.00%) 
Encephalopathy  1  2/1938 (0.10%)  0/1951 (0.00%) 
Intracranial hemorrhage  1  2/1938 (0.10%)  6/1951 (0.31%) 
Nervous system disorders - Other, specify  1  3/1938 (0.15%)  2/1951 (0.10%) 
Stroke  1  2/1938 (0.10%)  2/1951 (0.10%) 
Psychiatric disorders     
Depression  1  6/1938 (0.31%)  2/1951 (0.10%) 
Personality change  1  0/1938 (0.00%)  1/1951 (0.05%) 
Psychosis  1  1/1938 (0.05%)  0/1951 (0.00%) 
Suicidal ideation  1  0/1938 (0.00%)  1/1951 (0.05%) 
Suicide attempt  1  1/1938 (0.05%)  1/1951 (0.05%) 
Renal and urinary disorders     
Urinary incontinence  1  1/1938 (0.05%)  0/1951 (0.00%) 
Urinary tract obstruction  1  0/1938 (0.00%)  1/1951 (0.05%) 
Chronic kidney disease  1  0/1938 (0.00%)  1/1951 (0.05%) 
Acute kidney injury  1  2/1938 (0.10%)  2/1951 (0.10%) 
Respiratory, thoracic and mediastinal disorders     
Adult respiratory distress syndrome  1  1/1938 (0.05%)  0/1951 (0.00%) 
Aspiration  1  1/1938 (0.05%)  1/1951 (0.05%) 
Dyspnea  1  1/1938 (0.05%)  2/1951 (0.10%) 
Respiratory failure  1  6/1938 (0.31%)  7/1951 (0.36%) 
Respiratory, thoracic and mediastinal disorders - Other, specify  1  1/1938 (0.05%)  1/1951 (0.05%) 
Mediastinal hemorrhage  1  0/1938 (0.00%)  1/1951 (0.05%) 
Vascular disorders     
Hematoma  1  1/1938 (0.05%)  2/1951 (0.10%) 
Hypertension  1  2/1938 (0.10%)  1/1951 (0.05%) 
Hypotension  1  1/1938 (0.05%)  0/1951 (0.00%) 
Thromboembolic event  1  8/1938 (0.41%)  1/1951 (0.05%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE v4.0
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Placebo Letrozole
Affected / at Risk (%) Affected / at Risk (%)
Total   336/1938 (17.34%)   400/1951 (20.50%) 
Musculoskeletal and connective tissue disorders     
Arthralgia  1  302/1938 (15.58%)  347/1951 (17.79%) 
Myalgia  1  118/1938 (6.09%)  149/1951 (7.64%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE v4.0
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Director, Department of Regulatory Affairs
Organization: NRG Oncology
Phone: 412-339-5300
EMail: langerj@nrgoncology.org
Layout table for additonal information
Responsible Party: NSABP Foundation Inc
ClinicalTrials.gov Identifier: NCT00382070    
Other Study ID Numbers: NSABP B-42
U10CA012027 ( U.S. NIH Grant/Contract )
First Submitted: September 26, 2006
First Posted: September 28, 2006
Results First Submitted: April 28, 2021
Results First Posted: May 20, 2021
Last Update Posted: May 20, 2021