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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.

ClinicalTrials.gov Identifier: NCT00382070

Recruitment Status : Active, not recruiting

First Posted : September 28, 2006

Results First Posted : May 20, 2021

Last Update Posted : March 22, 2024

View this study on the modernized ClinicalTrials.gov

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

Participant Flow

Recruitment Details
Pre-assignment Details


Arm/Group Title	Group 2 Letrozole	Group 1 Placebo
Arm/Group Description	Patients receive oral letrozole onc...	Patients receive oral placebo once ...
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

Baseline Characteristics

Arm/Group Title		Placebo	Letrozole	Total
Arm/Group Description		Placebo	Letrozole	Total of all reporting groups
Arm/Group Description		Placebo	Letrozole	Total of all reporting groups
Overall Number of Baseline Participants		1983	1983	3966
Baseline Analysis Population Description		[Not Specified]
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%

Outcome Measures

1.Primary Outcome


Title	Disease-free Survival
Description	Percentage of patients free from DFS events. DFS events include local,...
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.

Outcome Measure Data

Analysis Population Description

[Not Specified]


Arm/Group Title	Group 2 Letrozole	Group 1 Placebo
Arm/Group Description:	Patients receive oral letrozole onc...	Patients receive oral placebo once ...
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
Description	Percentage of patients alive
Description	Percentage of patients alive
Time Frame	7 years

Outcome Measure Data

Analysis Population Description

Patients with any type of follow up.


Arm/Group Title	Group 2 Letrozole	Group 1 Placebo
Arm/Group Description:	Patients receive oral letrozole onc...	Patients receive oral placebo once ...
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
Description	Cumulative incidence of breast-cancer-free interval events. BCFI event...
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

Outcome Measure Data

Analysis Population Description

[Not Specified]


Arm/Group Title	Group 2 Letrozole	Group 1 Placebo
Arm/Group Description:	Patients receive oral letrozole onc...	Patients receive oral placebo once ...
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
Description	Cumulative incidence of distant recurrences.
Description	Cumulative incidence of distant recurrences.
Time Frame	7 years

Outcome Measure Data

Analysis Population Description

[Not Specified]


Arm/Group Title	Group 2 Letrozole	Group 1 Placebo
Arm/Group Description:	Patients receive oral letrozole onc...	Patients receive oral placebo once ...
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
Description	Cumulative incidence of osteoporotic-related fractures defined as Coll...
Description	Cumulative incidence of osteoporotic-related fractures defined as Colles', hip or spinal fractures
Time Frame	7 years

Outcome Measure Data

Analysis Population Description

[Not Specified]


Arm/Group Title	Group 2 Letrozole	Group 1 Placebo
Arm/Group Description:	Patients receive oral letrozole onc...	Patients receive oral placebo once ...
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
Description	Cumulative incidence of arterial thrombotic events, as defined by CTCA...
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

Outcome Measure Data

Analysis Population Description

[Not Specified]


Arm/Group Title	Group 2 Letrozole	Group 1 Placebo
Arm/Group Description:	Patients receive oral letrozole onc...	Patients receive oral placebo once ...
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

Adverse Events

Time Frame	[Not Specified]
Adverse Event Reporting Description	Participants at Risk includes any patient who submitted an AE form.

Arm/Group Title	Placebo	Letrozole
Arm/Group Description	Placebo	Letrozole
Arm/Group Description	Placebo	Letrozole
All-Cause Mortality
	Placebo	Letrozole
	Affected / at Risk (%)	Affected / at Risk (%)
Total	--/--	--/--
Serious Adverse Events 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
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

Limitations and Caveats

[Not Specified]

More Information

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

Publications:

Mamounas EP, Lembersky B, Jeong JH, Cronin W, Harkins B, Geyer C, Wickerham DL, Paik S, Costantino J, Wolmark N. NSABP B-42: a clinical trial to determine the efficacy of five years of letrozole compared with placebo in patients completing five years of hormonal therapy consisting of an aromatase inhibitor (AI) or tamoxifen followed by an AI in prolonging disease-free survival in postmenopausal women with hormone receptor-positive breast cancer. Clin Breast Cancer. 2006 Dec;7(5):416-21. doi: 10.3816/CBC.2006.n.061. No abstract available.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Mamounas EP, Bandos H, Lembersky BC, Jeong JH, Geyer CE Jr, Rastogi P, Fehrenbacher L, Graham ML, Chia SK, Brufsky AM, Walshe JM, Soori GS, Dakhil SR, Seay TE, Wade JL 3rd, McCarron EC, Paik S, Swain SM, Wickerham DL, Wolmark N. Use of letrozole after aromatase inhibitor-based therapy in postmenopausal breast cancer (NRG Oncology/NSABP B-42): a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet Oncol. 2019 Jan;20(1):88-99. doi: 10.1016/S1470-2045(18)30621-1. Epub 2018 Nov 30. Erratum In: Lancet Oncol. 2019 Jan;20(1):e10.

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:	March 22, 2024