Trial Outcomes & Findings for Letrozole in Treating Postmenopausal Women Who Have Received Hormone Therapy for Hormone Receptor-Positive Breast Cancer (NCT NCT00382070)

NCT ID: NCT00382070

Last Updated: 2024-03-22

Results Overview

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.

Recruitment status

ACTIVE_NOT_RECRUITING

Study phase

PHASE3

Target enrollment

3966 participants

Primary outcome timeframe

7 years.

Results posted on

2024-03-22

Participant Flow

Participant milestones

Participant milestones
Measure	Group 2 Letrozole Patients receive oral letrozole once daily for up to 5 years. Letrozole: Letrozole 2.5 mg taken orally once daily for 5 years	Group 1 Placebo Patients receive oral placebo once daily for up to 5 years. Placebo: Placebo tablet taken orally once daily for 5 years
Overall Study STARTED	1983	1983
Overall Study COMPLETED	1950	1953
Overall Study NOT COMPLETED	33	30

Reasons for withdrawal

Reasons for withdrawal
Measure	Group 2 Letrozole Patients receive oral letrozole once daily for up to 5 years. Letrozole: Letrozole 2.5 mg taken orally once daily for 5 years	Group 1 Placebo Patients receive oral placebo once daily for up to 5 years. Placebo: Placebo tablet taken orally once daily for 5 years
Overall Study No follow up data mapped to Other	17	19
Overall Study Patient not at risk for primary endpoint mapped to Other	7	0
Overall Study No clinical assessment	9	11

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo n=1983 Participants Placebo	Letrozole n=1983 Participants Letrozole	Total n=3966 Participants Total of all reporting groups
Age, Continuous	63 years STANDARD_DEVIATION 8.4 • n=5 Participants	63 years STANDARD_DEVIATION 8.7 • n=7 Participants	63 years STANDARD_DEVIATION 8.6 • n=5 Participants
Sex: Female, Male Female	1983 Participants n=5 Participants	1983 Participants n=7 Participants	3966 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Group 2 Letrozole n=1950 Participants Patients receive oral letrozole once daily for up to 5 years. Letrozole: Letrozole 2.5 mg taken orally once daily for 5 years	Group 1 Placebo n=1953 Participants Patients receive oral placebo once daily for up to 5 years. Placebo: Placebo tablet taken orally once daily for 5 years
Disease-free Survival	84.7 percentage of patients free of disease	81.3 percentage of patients free of disease

SECONDARY outcome

Timeframe: 7 years

Population: Patients with any type of follow up.

Percentage of patients alive

Outcome measures

Outcome measures
Measure	Group 2 Letrozole n=1959 Participants Patients receive oral letrozole once daily for up to 5 years. Letrozole: Letrozole 2.5 mg taken orally once daily for 5 years	Group 1 Placebo n=1964 Participants Patients receive oral placebo once daily for up to 5 years. Placebo: Placebo tablet taken orally once daily for 5 years
Overall Survival	91.8 percentage of patients alive	92.3 percentage of patients alive

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Group 2 Letrozole n=1950 Participants Patients receive oral letrozole once daily for up to 5 years. Letrozole: Letrozole 2.5 mg taken orally once daily for 5 years	Group 1 Placebo n=1953 Participants Patients receive oral placebo once daily for up to 5 years. Placebo: Placebo tablet taken orally once daily for 5 years
Breast Cancer-free Interval	6.7 percentage of patients	10 percentage of patients

SECONDARY outcome

Timeframe: 7 years

Cumulative incidence of distant recurrences.

Outcome measures

Outcome measures
Measure	Group 2 Letrozole n=1950 Participants Patients receive oral letrozole once daily for up to 5 years. Letrozole: Letrozole 2.5 mg taken orally once daily for 5 years	Group 1 Placebo n=1953 Participants Patients receive oral placebo once daily for up to 5 years. Placebo: Placebo tablet taken orally once daily for 5 years
Distant Recurrence	3.9 percentage of patients	5.8 percentage of patients

SECONDARY outcome

Timeframe: 7 years

Cumulative incidence of osteoporotic-related fractures defined as Colles', hip or spinal fractures

Outcome measures

Outcome measures
Measure	Group 2 Letrozole n=1950 Participants Patients receive oral letrozole once daily for up to 5 years. Letrozole: Letrozole 2.5 mg taken orally once daily for 5 years	Group 1 Placebo n=1953 Participants Patients receive oral placebo once daily for up to 5 years. Placebo: Placebo tablet taken orally once daily for 5 years
Osteoporotic-related Fractures	5.4 percentage of patients	4.8 percentage of patients

SECONDARY outcome

Timeframe: 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 \[cerebrovascular event, arterial insufficiency\]).

Outcome measures

Outcome measures
Measure	Group 2 Letrozole n=1950 Participants Patients receive oral letrozole once daily for up to 5 years. Letrozole: Letrozole 2.5 mg taken orally once daily for 5 years	Group 1 Placebo n=1953 Participants Patients receive oral placebo once daily for up to 5 years. Placebo: Placebo tablet taken orally once daily for 5 years
Arterial Thrombotic Events	4.0 percentage of patients	3.4 percentage of patients

Adverse Events

Placebo

Serious events: 87 serious events

Other events: 336 other events

Deaths: 0 deaths

Letrozole

Serious events: 80 serious events

Other events: 400 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	Placebo n=1938 participants at risk Placebo	Letrozole n=1951 participants at risk Letrozole
Musculoskeletal and connective tissue disorders Arthralgia	15.6% 302/1938 Participants at Risk includes any patient who submitted an AE form.	17.8% 347/1951 Participants at Risk includes any patient who submitted an AE form.
Musculoskeletal and connective tissue disorders Myalgia	6.1% 118/1938 Participants at Risk includes any patient who submitted an AE form.	7.6% 149/1951 Participants at Risk includes any patient who submitted an AE form.

Additional Information

Director, Department of Regulatory Affairs

NRG Oncology

Phone: 412-339-5300

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60

Measure	Placebo n=1938 participants at risk Placebo	Letrozole n=1951 participants at risk Letrozole
Respiratory, thoracic and mediastinal disorders Adult respiratory distress syndrome	0.05% 1/1938 Participants at Risk includes any patient who submitted an AE form.	0.00% 0/1951 Participants at Risk includes any patient who submitted an AE form.
Investigations Alanine aminotransferase increased (ALT/SGPT)	0.05% 1/1938 Participants at Risk includes any patient who submitted an AE form.	0.10% 2/1951 Participants at Risk includes any patient who submitted an AE form.
Nervous system disorders Amnesia	0.05% 1/1938 Participants at Risk includes any patient who submitted an AE form.	0.00% 0/1951 Participants at Risk includes any patient who submitted an AE form.
Blood and lymphatic system disorders Anemia	0.26% 5/1938 Participants at Risk includes any patient who submitted an AE form.	0.10% 2/1951 Participants at Risk includes any patient who submitted an AE form.
Injury, poisoning and procedural complications Aortic injury	0.05% 1/1938 Participants at Risk includes any patient who submitted an AE form.	0.00% 0/1951 Participants at Risk includes any patient who submitted an AE form.
Investigations Aspartate aminotransferase increased (AST/SGOT)	0.15% 3/1938 Participants at Risk includes any patient who submitted an AE form.	0.10% 2/1951 Participants at Risk includes any patient who submitted an AE form.
Respiratory, thoracic and mediastinal disorders Aspiration	0.05% 1/1938 Participants at Risk includes any patient who submitted an AE form.	0.05% 1/1951 Participants at Risk includes any patient who submitted an AE form.
Cardiac disorders Atrial fibrillation	0.05% 1/1938 Participants at Risk includes any patient who submitted an AE form.	0.05% 1/1951 Participants at Risk includes any patient who submitted an AE form.
Infections and infestations Bladder infection	0.00% 0/1938 Participants at Risk includes any patient who submitted an AE form.	0.05% 1/1951 Participants at Risk includes any patient who submitted an AE form.
Investigations Blood bilirubin increased	0.00% 0/1938 Participants at Risk includes any patient who submitted an AE form.	0.05% 1/1951 Participants at Risk includes any patient who submitted an AE form.
Cardiac disorders Cardiac arrest	0.15% 3/1938 Participants at Risk includes any patient who submitted an AE form.	0.21% 4/1951 Participants at Risk includes any patient who submitted an AE form.
Cardiac disorders Cardiac disorders - Other, specify	0.15% 3/1938 Participants at Risk includes any patient who submitted an AE form.	0.10% 2/1951 Participants at Risk includes any patient who submitted an AE form.
Investigations Cardiac troponin I increased	0.10% 2/1938 Participants at Risk includes any patient who submitted an AE form.	0.05% 1/1951 Participants at Risk includes any patient who submitted an AE form.
Investigations Cardiac troponin T increased	0.05% 1/1938 Participants at Risk includes any patient who submitted an AE form.	0.05% 1/1951 Participants at Risk includes any patient who submitted an AE form.
Investigations Creatinine increased	0.05% 1/1938 Participants at Risk includes any patient who submitted an AE form.	0.05% 1/1951 Participants at Risk includes any patient who submitted an AE form.
General disorders Death NOS	0.05% 1/1938 Participants at Risk includes any patient who submitted an AE form.	0.05% 1/1951 Participants at Risk includes any patient who submitted an AE form.
Metabolism and nutrition disorders Dehydration	0.10% 2/1938 Participants at Risk includes any patient who submitted an AE form.	0.00% 0/1951 Participants at Risk includes any patient who submitted an AE form.
Psychiatric disorders Depression	0.31% 6/1938 Participants at Risk includes any patient who submitted an AE form.	0.10% 2/1951 Participants at Risk includes any patient who submitted an AE form.
Respiratory, thoracic and mediastinal disorders Dyspnea	0.05% 1/1938 Participants at Risk includes any patient who submitted an AE form.	0.10% 2/1951 Participants at Risk includes any patient who submitted an AE form.
Nervous system disorders Encephalopathy	0.10% 2/1938 Participants at Risk includes any patient who submitted an AE form.	0.00% 0/1951 Participants at Risk includes any patient who submitted an AE form.
Injury, poisoning and procedural complications Fracture	0.00% 0/1938 Participants at Risk includes any patient who submitted an AE form.	0.10% 2/1951 Participants at Risk includes any patient who submitted an AE form.
Cardiac disorders Heart failure	0.10% 2/1938 Participants at Risk includes any patient who submitted an AE form.	0.26% 5/1951 Participants at Risk includes any patient who submitted an AE form.
Vascular disorders Hematoma	0.05% 1/1938 Participants at Risk includes any patient who submitted an AE form.	0.10% 2/1951 Participants at Risk includes any patient who submitted an AE form.
Hepatobiliary disorders Hepatic failure	0.00% 0/1938 Participants at Risk includes any patient who submitted an AE form.	0.05% 1/1951 Participants at Risk includes any patient who submitted an AE form.
Hepatobiliary disorders Hepatobiliary disorders - Other, specify	0.00% 0/1938 Participants at Risk includes any patient who submitted an AE form.	0.05% 1/1951 Participants at Risk includes any patient who submitted an AE form.
Metabolism and nutrition disorders Hypercalcemia	0.10% 2/1938 Participants at Risk includes any patient who submitted an AE form.	0.10% 2/1951 Participants at Risk includes any patient who submitted an AE form.
Metabolism and nutrition disorders Hyperglycemia	0.00% 0/1938 Participants at Risk includes any patient who submitted an AE form.	0.10% 2/1951 Participants at Risk includes any patient who submitted an AE form.
Metabolism and nutrition disorders Hyperkalemia	0.05% 1/1938 Participants at Risk includes any patient who submitted an AE form.	0.10% 2/1951 Participants at Risk includes any patient who submitted an AE form.
Vascular disorders Hypertension	0.10% 2/1938 Participants at Risk includes any patient who submitted an AE form.	0.05% 1/1951 Participants at Risk includes any patient who submitted an AE form.
Metabolism and nutrition disorders Hypertriglyceridemia	0.05% 1/1938 Participants at Risk includes any patient who submitted an AE form.	0.00% 0/1951 Participants at Risk includes any patient who submitted an AE form.
Metabolism and nutrition disorders Hyperuricemia	0.05% 1/1938 Participants at Risk includes any patient who submitted an AE form.	0.05% 1/1951 Participants at Risk includes any patient who submitted an AE form.
Metabolism and nutrition disorders Hypocalcemia	0.00% 0/1938 Participants at Risk includes any patient who submitted an AE form.	0.05% 1/1951 Participants at Risk includes any patient who submitted an AE form.
Metabolism and nutrition disorders Hypokalemia	0.00% 0/1938 Participants at Risk includes any patient who submitted an AE form.	0.21% 4/1951 Participants at Risk includes any patient who submitted an AE form.
Metabolism and nutrition disorders Hyponatremia	0.10% 2/1938 Participants at Risk includes any patient who submitted an AE form.	0.05% 1/1951 Participants at Risk includes any patient who submitted an AE form.
Vascular disorders Hypotension	0.05% 1/1938 Participants at Risk includes any patient who submitted an AE form.	0.00% 0/1951 Participants at Risk includes any patient who submitted an AE form.
Infections and infestations Infections and infestations - Other, specify	0.05% 1/1938 Participants at Risk includes any patient who submitted an AE form.	0.00% 0/1951 Participants at Risk includes any patient who submitted an AE form.
Injury, poisoning and procedural complications Injury, poisoning and procedural complications - Other, specify	0.00% 0/1938 Participants at Risk includes any patient who submitted an AE form.	0.05% 1/1951 Participants at Risk includes any patient who submitted an AE form.
Nervous system disorders Intracranial hemorrhage	0.10% 2/1938 Participants at Risk includes any patient who submitted an AE form.	0.31% 6/1951 Participants at Risk includes any patient who submitted an AE form.
Investigations Lipase increased	0.00% 0/1938 Participants at Risk includes any patient who submitted an AE form.	0.10% 2/1951 Participants at Risk includes any patient who submitted an AE form.
General disorders Multi-organ failure	0.10% 2/1938 Participants at Risk includes any patient who submitted an AE form.	0.00% 0/1951 Participants at Risk includes any patient who submitted an AE form.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Myelodysplastic syndrome	0.21% 4/1938 Participants at Risk includes any patient who submitted an AE form.	0.10% 2/1951 Participants at Risk includes any patient who submitted an AE form.
Cardiac disorders Myocardial infarction	0.46% 9/1938 Participants at Risk includes any patient who submitted an AE form.	0.21% 4/1951 Participants at Risk includes any patient who submitted an AE form.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify	0.26% 5/1938 Participants at Risk includes any patient who submitted an AE form.	0.21% 4/1951 Participants at Risk includes any patient who submitted an AE form.
Nervous system disorders Nervous system disorders - Other, specify	0.15% 3/1938 Participants at Risk includes any patient who submitted an AE form.	0.10% 2/1951 Participants at Risk includes any patient who submitted an AE form.
Investigations Neutrophil count decreased	0.00% 0/1938 Participants at Risk includes any patient who submitted an AE form.	0.05% 1/1951 Participants at Risk includes any patient who submitted an AE form.
Cardiac disorders Pericardial effusion	0.05% 1/1938 Participants at Risk includes any patient who submitted an AE form.	0.05% 1/1951 Participants at Risk includes any patient who submitted an AE form.
Psychiatric disorders Personality change	0.00% 0/1938 Participants at Risk includes any patient who submitted an AE form.	0.05% 1/1951 Participants at Risk includes any patient who submitted an AE form.
Investigations Platelet count decreased	0.05% 1/1938 Participants at Risk includes any patient who submitted an AE form.	0.05% 1/1951 Participants at Risk includes any patient who submitted an AE form.
Psychiatric disorders Psychosis	0.05% 1/1938 Participants at Risk includes any patient who submitted an AE form.	0.00% 0/1951 Participants at Risk includes any patient who submitted an AE form.
Gastrointestinal disorders Rectal hemorrhage	0.05% 1/1938 Participants at Risk includes any patient who submitted an AE form.	0.00% 0/1951 Participants at Risk includes any patient who submitted an AE form.
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.31% 6/1938 Participants at Risk includes any patient who submitted an AE form.	0.36% 7/1951 Participants at Risk includes any patient who submitted an AE form.
Respiratory, thoracic and mediastinal disorders Respiratory, thoracic and mediastinal disorders - Other, specify	0.05% 1/1938 Participants at Risk includes any patient who submitted an AE form.	0.05% 1/1951 Participants at Risk includes any patient who submitted an AE form.
Infections and infestations Sepsis	0.10% 2/1938 Participants at Risk includes any patient who submitted an AE form.	0.21% 4/1951 Participants at Risk includes any patient who submitted an AE form.
Investigations Serum amylase increased	0.00% 0/1938 Participants at Risk includes any patient who submitted an AE form.	0.05% 1/1951 Participants at Risk includes any patient who submitted an AE form.
Infections and infestations Skin infection	0.00% 0/1938 Participants at Risk includes any patient who submitted an AE form.	0.05% 1/1951 Participants at Risk includes any patient who submitted an AE form.
Gastrointestinal disorders Small intestinal obstruction	0.05% 1/1938 Participants at Risk includes any patient who submitted an AE form.	0.00% 0/1951 Participants at Risk includes any patient who submitted an AE form.
Nervous system disorders Stroke	0.10% 2/1938 Participants at Risk includes any patient who submitted an AE form.	0.10% 2/1951 Participants at Risk includes any patient who submitted an AE form.
Psychiatric disorders Suicidal ideation	0.00% 0/1938 Participants at Risk includes any patient who submitted an AE form.	0.05% 1/1951 Participants at Risk includes any patient who submitted an AE form.
Psychiatric disorders Suicide attempt	0.05% 1/1938 Participants at Risk includes any patient who submitted an AE form.	0.05% 1/1951 Participants at Risk includes any patient who submitted an AE form.
Vascular disorders Thromboembolic event	0.41% 8/1938 Participants at Risk includes any patient who submitted an AE form.	0.05% 1/1951 Participants at Risk includes any patient who submitted an AE form.
Injury, poisoning and procedural complications Tracheal obstruction	0.00% 0/1938 Participants at Risk includes any patient who submitted an AE form.	0.05% 1/1951 Participants at Risk includes any patient who submitted an AE form.
Renal and urinary disorders Urinary incontinence	0.05% 1/1938 Participants at Risk includes any patient who submitted an AE form.	0.00% 0/1951 Participants at Risk includes any patient who submitted an AE form.
Infections and infestations Urinary tract infection	0.10% 2/1938 Participants at Risk includes any patient who submitted an AE form.	0.21% 4/1951 Participants at Risk includes any patient who submitted an AE form.
Cardiac disorders Ventricular fibrillation	0.00% 0/1938 Participants at Risk includes any patient who submitted an AE form.	0.05% 1/1951 Participants at Risk includes any patient who submitted an AE form.
Infections and infestations Wound infection	0.00% 0/1938 Participants at Risk includes any patient who submitted an AE form.	0.05% 1/1951 Participants at Risk includes any patient who submitted an AE form.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Leukemia secondary to oncology chemotherapy	0.05% 1/1938 Participants at Risk includes any patient who submitted an AE form.	0.15% 3/1951 Participants at Risk includes any patient who submitted an AE form.
Investigations White blood cell decreased	0.00% 0/1938 Participants at Risk includes any patient who submitted an AE form.	0.05% 1/1951 Participants at Risk includes any patient who submitted an AE form.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Treatment related secondary malignancy	0.00% 0/1938 Participants at Risk includes any patient who submitted an AE form.	0.10% 2/1951 Participants at Risk includes any patient who submitted an AE form.
Cardiac disorders Acute coronary syndrome	0.00% 0/1938 Participants at Risk includes any patient who submitted an AE form.	0.05% 1/1951 Participants at Risk includes any patient who submitted an AE form.
Gastrointestinal disorders Upper gastrointestinal hemorrhage	0.00% 0/1938 Participants at Risk includes any patient who submitted an AE form.	0.05% 1/1951 Participants at Risk includes any patient who submitted an AE form.
Respiratory, thoracic and mediastinal disorders Mediastinal hemorrhage	0.00% 0/1938 Participants at Risk includes any patient who submitted an AE form.	0.05% 1/1951 Participants at Risk includes any patient who submitted an AE form.
Cardiac disorders Right ventricular dysfunction	0.05% 1/1938 Participants at Risk includes any patient who submitted an AE form.	0.00% 0/1951 Participants at Risk includes any patient who submitted an AE form.
Infections and infestations Lung infection	0.31% 6/1938 Participants at Risk includes any patient who submitted an AE form.	0.00% 0/1951 Participants at Risk includes any patient who submitted an AE form.
Renal and urinary disorders Urinary tract obstruction	0.00% 0/1938 Participants at Risk includes any patient who submitted an AE form.	0.05% 1/1951 Participants at Risk includes any patient who submitted an AE form.
Cardiac disorders Aortic valve disease	0.26% 5/1938 Participants at Risk includes any patient who submitted an AE form.	0.15% 3/1951 Participants at Risk includes any patient who submitted an AE form.
Renal and urinary disorders Chronic kidney disease	0.00% 0/1938 Participants at Risk includes any patient who submitted an AE form.	0.05% 1/1951 Participants at Risk includes any patient who submitted an AE form.
Musculoskeletal and connective tissue disorders Soft tissue necrosis lower limb	0.00% 0/1938 Participants at Risk includes any patient who submitted an AE form.	0.05% 1/1951 Participants at Risk includes any patient who submitted an AE form.
Renal and urinary disorders Acute kidney injury	0.10% 2/1938 Participants at Risk includes any patient who submitted an AE form.	0.10% 2/1951 Participants at Risk includes any patient who submitted an AE form.
Cardiac disorders Left ventricular systolic dysfunction	0.10% 2/1938 Participants at Risk includes any patient who submitted an AE form.	0.31% 6/1951 Participants at Risk includes any patient who submitted an AE form.