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These highlights do not include all the information needed to use Letrozole Tablets, USP safely and effectively. See full prescribing information for Letrozole Tablets, USP. Letrozole Tablets, USPInitial U.S. Approval: 1997 | Letrozole

05:24 EDT 27th August 2014 | BioPortfolio

Note: While we endeavour to keep our records up-to-date one should not rely on these details being accurate without first consulting a professional. Click here to read our full medical disclaimer.

Letrozole tablet, USP is indicated for the adjuvant treatment of postmenopausal women with hormone receptor positive early breast cancer.

Letrozole Tablets, USP are indicated for the extended adjuvant treatment of early breast cancer in postmenopausal women, who have received 5 years of adjuvant tamoxifen therapy. The effectiveness of Letrozole Tablets, USP in extended adjuvant treatment of early breast cancer is based on an analysis of disease-free survival in patients treated with Letrozole Tablets, USP for a median of 60 months [see Clinical Studies (14.2, 14.3)].

Letrozole Tablets, USP are indicated for first-line treatment of postmenopausal women with hormone receptor positive or unknown, locally advanced or metastatic breast cancer. Letrozole Tablets, USP are also indicated for the treatment of advanced breast cancer in postmenopausal women with disease progression following antiestrogen therapy [see Clinical Studies (14.4, 14.5)].

The recommended dose of Letrozole Tablets, USP is one 2.5 mg tablet administered once a day, without regard to meals.

In the adjuvant setting, the optimal duration of treatment with letrozole is unknown. The planned duration of treatment in the study was 5 years with 73% of the patients having completed adjuvant therapy. Treatment should be discontinued at relapse [see Clinical Studies (14.1)].

In the extended adjuvant setting, the optimal treatment duration with letrozole tablet is not known. The planned duration of treatment in the study was 5 years. In the final updated analysis, conducted at a median follow-up of 62 months, the median treatment duration was 60 months. Seventy-one percent of patients were treated for at least 3 years and 58% of patients completed at least 4.5 years of extended adjuvant treatment. The treatment should be discontinued at tumor relapse [see Clinical Studies (14.2)].

In patients with advanced disease, treatment with letrozole tablet should continue until tumor progression is evident. [see Clinical Studies (14.4, 14.5)]

No dosage adjustment is recommended for patients with mild to moderate hepatic impairment, although letrozole tablet blood concentrations were modestly increased in subjects with moderate hepatic impairment due to cirrhosis. The dose of letrozole tablet in patients with cirrhosis and severe hepatic dysfunction should be reduced by 50% [see Warnings and Precautions (5.3)]. The recommended dose of letrozole tablet for such patients is 2.5 mg administered every other day. The effect of hepatic impairment on Letrozole tablet exposure in noncirrhotic cancer patients with elevated bilirubin levels has not been determined.

No dosage adjustment is required for patients with renal impairment if creatinine clearance is ≥10 mL/min. [see Clinical Pharmacology (12.3)].

2.5 mg tablets: dark yellow, coated, round, slightly biconvex, with beveled edges (debossed with “E126” on one side and plain on the other side).

Letrozole tablets may cause fetal harm when administered to a pregnant woman and the clinical benefit to premenopausal women with breast cancer has not been demonstrated. Letrozole tablet is contraindicated in women who are or may become pregnant. If Letrozole tablet is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to a fetus. [see Use in Specific Populations (8.1)]

Use of Letrozole tablet may cause decreases in bone mineral density (BMD). Consideration should be given to monitoring BMD. Results of a substudy to evaluate safety in the adjuvant setting comparing the effect on lumbar spine (L2­L4) bone mineral density (BMD) of adjuvant treatment with letrozole to that with tamoxifen showed at 24 months a median decrease in lumbar spine BMD of 4.1% in the letrozole arm compared to a median increase of 0.3% in the tamoxifen arm (difference = 4.4%) (P<0.0001) [See Adverse reactions (6.1)]. Updated results from the BMD sub-study in the extended adjuvant setting demonstrated that at 2 years patients receiving letrozole had a median decrease from baseline of 3.8% in hip BMD compared to a median decrease of 2.0% in the placebo group. The changes from baseline in lumbar spine BMD in letrozole and placebo treated groups were not significantly different [see Adverse Reactions (6.2)].

In the adjuvant trial the incidence of bone fractures at any time after randomization was 13.8% for letrozole and 10.5% for tamoxifen. The incidence of osteoporosis was 5.1% for letrozole and 2.7% for tamoxifen [See Adverse Reactions (6.1)]. In the extended adjuvant trial the incidence of bone fractures at any time after randomization was 13.3% for letrozole and 7.8% for placebo. The incidence of new osteoporosis was 14.5% for letrozole and 7.8% for placebo [see Adverse Reactions (6.3)].

Consideration should be given to monitoring serum cholesterol. In the adjuvant trial hypercholesterolemia was reported in 52.3% of letrozole patients and 28.6% of tamoxifen patients. CTC grade 3-4 hypercholesterolemia was reported in 0.4% of letrozole patients and 0.1% of tamoxifen patients. Also in the adjuvant setting, an increase of ≥1.5 X ULN in total cholesterol (generally non-fasting) was observed in patients on monotherapy who had baseline total serum cholesterol within the normal range (i.e., <=1.5 X ULN) in 151/1843 (8.2%) on letrozole vs 57/1840 (3.2%). Lipid lowering medications were required for 25% of patients on letrozole and 16% on tamoxifen [see Adverse Reactions (6.1)].

Subjects with cirrhosis and severe hepatic impairment who were dosed with 2.5 mg of letrozole experienced approximately twice the exposure to letrozole as healthy volunteers with normal liver function. Therefore, a dose reduction is recommended for this patient population. The effect of hepatic impairment on letrozole exposure in cancer patients with elevated bilirubin levels has not been determined. [see Dosage and Administration (2.5)]

Because fatigue, dizziness, and somnolence have been reported with the use of Letrozole tablet, caution is advised when driving or using machinery until it is known how the patient reacts to letrozole use.

No dose-related effect of letrozole on any hematologic or clinical chemistry parameter was evident. Moderate decreases in lymphocyte counts, of uncertain clinical significance, were observed in some patients receiving Letrozole tablets 2.5 mg. This depression was transient in about half of those affected. Two patients on Letrozole tablets developed thrombocytopenia; relationship to the study drug was unclear. Patient withdrawal due to laboratory abnormalities, whether related to study treatment or not, was infrequent.

The most serious adverse reactions from the use of letrozole tablets are:

Because clinical trials are conducted under widely varying conditions, adverse reactions rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

The median treatment duration of adjuvant treatment was 60 months and the median duration of follow-up for safety was 73 months for patients receiving letrozole tablets and tamoxifen.

Certain adverse reactions were prospectively specified for analysis, based on the known pharmacologic properties and side effect profiles of the two drugs.

Adverse reactions were analyzed irrespective of whether a symptom was present or absent at baseline. Most adverse reactions reported (approximately 75% of patients reporting 1 or more AE) were Grade 1 or Grade 2 applying the Common Toxicity Criteria Version 2.0/ Common Terminology Criteria for Adverse Events, version 3.0. Table 1 describes adverse reactions (Grades 1-4) irrespective of relationship to study treatment in the adjuvant trial for the monotherapy arms analysis (safety population).

When considering all grades during study treatment, a higher incidence of events was seen for letrozole tablets regarding fractures (10.1% vs 7.1%), myocardial infarctions (1.0% vs 0.5%), and arthralgia (25.2% vs 20.4%) (letrozole tablets vs tamoxifen respectively). A higher incidence was seen for tamoxifen regarding thromboembolic events (2.1% vs 3.6%), endometrial hyperplasia/cancer (0.3% vs 2.9%), and endometrial proliferation disorders (0.3% vs 1.8%) (letrozole tablets vs tamoxifen respectively).

At a median follow up of 73 months, a higher incidence of events was seen for letrozole tablets (13.8%) than for tamoxifen (10.5%) regarding fractures. A higher incidence was seen for tamoxifen compared to letrozole tablets regarding thromboembolic events (4.5% vs 2.9%), and endometrial hyperplasia or cancer (2.9% vs 0.4%) (tamoxifen vs letrozole tablets, respectively).

Bone Study: Results of a phase 3 safety trial in 262 post menopausal women with resected receptor positive early breast cancer in the adjuvant setting comparing the effect on lumbar spine (L2-L4) bone mineral density (BMD) of adjuvant treatment with letrozole to that with tamoxifen showed at 24 months a median decrease in lumbar spine BMD of 4.1% in the letrozole arm compared to a median increase of 0.3% in the tamoxifen arm (difference = 4.4%) (P<0.0001). No patients with a normal BMD at baseline became osteoporotic over the 2 years and only 1 patient with osteopenia at baseline (T score of -1.9) developed osteoporosis during the treatment period (assessment by central review). The results for total hip BMD were similar, although the differences between the two treatments were less pronounced. During the 2 year period, fractures were reported by 4 of 103 patients (4%) in the letrozole arm, and 6 of 97 patients (6%) in the tamoxifen arm.

Lipid Study: In a phase 3 safety trial in 262 post menopausal women with resected receptor positive early breast cancer at 24 months comparing the effects on lipid profiles of adjuvant letrozole to tamoxifen, 12% of patients on letrozole had at least one total cholesterol value of a higher CTCAE grade than at baseline compared with 4% of patients on tamoxifen.

Table 1: Patients with Adverse Reactions (CTC Grades 1-4, Irrespective of Relationship to Study Drug) in the Adjuvant Study – Monotherapy Arms Analysis (Median Follow-up 73 Months; Median Treatment 60 Months)
Grades 1-4 Grades 3-4
Adverse Reaction Letrozole
N=2448 n (%)
tamoxifen
N=2447 n (%)
Letrozole
N=2448 n (%)
tamoxifen
N=2447 n (%)
 Pts with any adverse event  2310 (94.4)  2214 (90.5)  635    (25.9)  604    (24.7)
 Hypercholesterolemia  1280 (52.3)   700 (28.6)  11    ( 0.4)  6    ( 0.2)
 Hot Flashes/Flushes  821 (33.5)   929 (38.0)  0    -  0    -
 Arthralgia/Arthritis  618 (25.2)   501 (20.4)  85    ( 3.5)  50    ( 2.0)
 Night Sweats  357 (14.6)   426 (17.4)  0    -  0    -
 Bone Fractures2  338 (13.8)   257 (10.5)  -    -  -    -
 Weight Increase  317 (12.9)  378 (15.4)  27    ( 1.1)  39    ( 1.6)
 Nausea  283 (11.6)   277 (11.3)  6    ( 0.2)  9    ( 0.4)
 Bone Fractures1  247 (10.1)  174 ( 7.1)  -    -  -    -
 Fatigue (Lethargy, Malaise, Asthenia)  235 ( 9.6)  250 (10.2)  6    ( 0.2)  7    ( 0.3)
 Myalgia  217 ( 8.9)  212 ( 8.7)  18    ( 0.7)  14    ( 0.6)
 Edema  164 ( 6.7)  160 ( 6.5)  3    ( 0.1)  1    (<0.1)
 1 During study treatment, based on Safety Monotherapy population
 2 Any time after randomization, including post treatment follow-up
 3 Excluding women who had undergone hysterectomy before study entry
 Note: Cardiovascular (including cerebrovascular and thromboembolic), skeletal and urogenital/endometrial events and second malignancies were collected life-long. All of these events were assumed to be of CTC grade 3-5 and were not individually graded.
Grades 1-4 Grades 3-4
Adverse Reaction Letrozole
N=2448 n (%)
tamoxifen
N=2447 n (%)
Letrozole
N=2448 n (%)
tamoxifen
N=2447 n (%)
 Weight Decrease  140 ( 5.7)  129 ( 5.3)  8    ( 0.3)  5    ( 0.2)
 Vaginal Bleeding  128 ( 5.2)  320 (13.1)  1    (<0.1)  8    ( 0.3)
 Back Pain  125 ( 5.1)  136 ( 5.6)  7    ( 0.3)  11    ( 0.4)
 Osteoporosis NOS  124 ( 5.1)  66 ( 2.7)  10    ( 0.4)  5    ( 0.2)
 Bone pain  123 ( 5.0)  109 ( 4.5)  6    ( 0.2)  4    ( 0.2)
 Depression  119 ( 4.9)  114 ( 4.7)  16    ( 0.7)  14    ( 0.6)
 Vaginal Irritation  111 ( 4.5)  77 ( 3.1)  2    (<0.1)  2    (<0.1)
 Headache  105 ( 4.3)  94 ( 3.8)  9    ( 0.4)  5    ( 0.2)
 Pain in extremity  103 ( 4.2)  79 ( 3.2)  6    ( 0.2)  4    ( 0.2)
 Osteopenia  87 ( 3.6)  74 ( 3.0)  0    -  2    (<0.1)
 Dizziness/Light-Headedness  84 ( 3.4)  84 ( 3.4)  1    (<0.1)  6    (0.2)
 Alopecia  83 ( 3.4)  84 ( 3.4)  0    -  0    -
 Vomiting  80 ( 3.3)  80 ( 3.3)  3    ( 0.1)  5    (0.2)
 Cataract  49 ( 2.0)  54 ( 2.2)  16    ( 0.7)  17    ( 0.7)
 Constipation  49 ( 2.0)  71 ( 2.9)  3    ( 0.1)  1    (<0.1)
 Breast pain  37 ( 1.5)  43 ( 1.8)  1    (<0.1)  0    -
 Anorexia  20 ( 0.8)  20 ( 0.8)  1    (<0.1)  1    (<0.1)
 Endometrial Hyperplasia/ Cancer2, 3  11/1909 ( 0.6)  70/1943 ( 3.6)  -    -  -    -
 Endometrial Proliferation Disorders  10 (0.3)  71 (1.8)  0    -  14    (0.6)
 Endometrial Hyperplasia/ Cancer1, 3  6/1909 ( 0.3)  57/1943 (2.9)  -    -  -    -
 Other Endometrial Disorders  2 (<0.1)  3 ( 0.1)  0    -  0    -
 Myocardial Infarction1  24 ( 1.0)  12 ( 0.5)  -    -  -    -
 Myocardial Infarction2  37 ( 1.5)  25 (1.0)  -    -  -    -
 Myocardial Ischemia  6 ( 0.2)  9 ( 0.4)  -    -  -    -
 Cerebrovascular Accident1  52 ( 2.1)  46 ( 1.9)  -    -  -    -
 Cerebrovascular Accident2  70 ( 2.9)  63 ( 2.6)  -    -  -    -
 Angina1  26 ( 1.1)  24 ( 1.0)  -    -  -    -
 Angina2  32 ( 1.3)  31 ( 1.3)  -    -  -    -
 Thromboembolic Event1  51 ( 2.1)  89 ( 3.6)  -    -  -    -
 Thromboembolic Event2  71 ( 2.9)  111 ( 4.5)  -    -  -    -
 Other Cardiovascular1  260 (10.6)   256 (10.5)  -    -  -    -
 Other Cardiovascular2  312 (12.7)   337 (13.8)  -    -  -    -
 Second Malignancies1  53 ( 2.2)  78 ( 3.2)  -    -  -    -
 Second Malignancies2  102 ( 4.2)  119 ( 4.9)  -    -  -    -

The median duration of extended adjuvant treatment was 24 months and the median duration of follow-up for safety was 28 months for patients receiving letrozole tablets and placebo.

Table 2 describes the adverse reactions occurring at a frequency of at least 5% in any treatment group during treatment. Most adverse reactions reported were Grade 1 and Grade 2 based on the Common Toxicity Criteria Version 2.0. In the extended adjuvant setting, the reported drug-related adverse reactions that were significantly different from placebo were hot flashes, arthralgia/arthritis, and myalgia.

Based on a median follow-up of patients for 28 months, the incidence of clinical fractures from the core randomized study in patients who received letrozole tablets was 5.9% (152) and placebo was 5.5% (142). The incidence of self-reported osteoporosis was higher in patients who received letrozole tablets 6.9% (176) than in patients who received placebo 5.5% (141). Bisphosphonates were administered to 21.1% of the patients who received letrozole tablets and 18.7% of the patients who received placebo.

The incidence of cardiovascular ischemic events from the core randomized study was comparable between patients who received letrozole tablets 6.8% (175) and placebo 6.5% (167).

A patient-reported measure that captures treatment impact on important symptoms associated with estrogen deficiency demonstrated a difference in favor of placebo for vasomotor and sexual symptom domains.

Bone Sub-study: [see Warnings and Precautions (5.1)].

Lipid Sub-study: In the extended adjuvant setting, based on a median duration of follow-up of 62 months, there was no significant difference between letrozole tablets and placebo in total cholesterol or in any lipid fraction at any time over 5 years. Use of lipid lowering drugs or dietary management of elevated lipids was allowed. [see Warnings and Precautions (5.2)].

Table 2: Percentage of Patients with Adverse Reactions
Number (%) of Patients
with Grade 1-4 Adverse
Reaction
Number (%) of Patients
with Grade 3-4 Adverse
Reaction
Letrozole
N=2563
Placebo
N=2573
Letrozole
N=2563
Placebo
N=2573
 Any Adverse Reaction  2232 (87.1)  2174 (84.5)  419 (16.3)  389 (15.1)
 Vascular Disorders  1375 (53.6)  1230 (47.8)  59 (2.3)  74 (2.9)
    Flushing  1273 (49.7)  1114 (43.3)  3 (0.1)  0 -
 General Disorders  1154 (45)  1090 (42.4)  30 (1.2)  28 (1.1)
    Asthenia  862 (33.6)  826 (32.1)  16 (0.6)  7 (0.3)
    Edema NOS  471 (18.4)  416 (16.2)  4 (0.2)  3 (0.1)
 Musculoskeletal Disorders  978 (38.2)  836 (32.5)  71 (2.8)  50 (1.9)
    Arthralgia  565 (22)  465 (18.1)  25 (1)  20 (0.8)
    Arthritis NOS  173 (6.7)  124 (4.8)  10 (0.4)  5 (0.2)
    Myalgia  171 (6.7)  122 (4.7)  8 (0.3)  6 (0.2)
    Back Pain  129 (5)  112 (4.4)  8 (0.3)  7 (0.3)
 Nervous System Disorders  863 (33.7)  819 (31.8)  65 (2.5)  58 (2.3)
    Headache  516 (20.1)  508 (19.7)  18 (0.7)  17 (0.7)
    Dizziness  363 (14.2)  342 (13.3)  9 (0.4)  6 (0.2)
 Skin Disorders  830 (32.4)  787 (30.6)  17 (0.7)  16 (0.6)
    Sweating Increased  619 (24.2)  577 (22.4)  1 (<0.1)  0 -
 Gastrointestinal Disorders  725 (28.3)  731 (28.4)  43 (1.7)  42 (1.6)
    Constipation  290 (11.3)  304 (11.8)  6 (0.2)  2 (<0.1)
    Nausea  221 (8.6)  212 (8.2)  3 (0.1)  10 (0.4)
    Diarrhea NOS  128 (5)  143 (5.6)  12 (0.5)  8 (0.3)
 Metabolic Disorders  551 (21.5)  537 (20.9)  24 (0.9)  32 (1.2)
    Hypercholesterolemia  401 (15.6)  398 (15.5)  2 (<0.1)  5 (0.2)
 Reproductive Disorders  303 (11.8)  357 (13.9)  9 (0.4)  8 (0.3)
    Vaginal Hemorrhage  123 (4.8)  171 (6.6)  2 (<0.1)  5 (0.2)
    Vulvovaginal Dryness  137 (5.3)  127 (4.9)  0 -  0 -
 Psychiatric Disorders  320 (12.5)  276 (10.7)  21 (0.8)  16 (0.6)
    Insomnia  149 (5.8)  120 (4.7)  2 (<0.1)  2 (<0.1)
 Respiratory Disorders  279 (10.9)  260 (10.1)  30 (1.2)  28 (1.1)
    Dyspnea  140 (5.5)  137 (5.3)  21 (0.8)  18 (0.7)
 Investigations  184 (7.2)  147 (5.7)  13 (0.5)  13 (0.5)
 Infections and Infestations  166 (6.5)  163 (6.3)  40 (1.6)  33 (1.3)
 Renal Disorders  130 (5.1)  100 (3.9)  12 (0.5)  6 (0.2)

The extended adjuvant treatment trial was unblinded early [see Adverse Reactions (6.2)]. At the updated (final analysis), overall the side effects seen were consistent to those seen at a median treatment duration of 24 months.

During treatment or within 30 days of stopping treatment (median duration of treatment 60 months) a higher rate of fractures was observed for letrozole tablets (10.4%) compared to placebo (5.8%), as also a higher rate of osteoporosis (letrozole tablets 12.2% vs placebo 6.4%).

Based on 62 months median duration of follow-up in the randomized letrozole arm in the Safety population the incidence of new fractures at any time after randomization was 13.3% for letrozole and 7.8% for placebo. The incidence of new osteoporosis was 14.5% for letrozole and 7.8% for placebo. During treatment or within 30 days of stopping treatment (median duration of treatment 60 months) the incidence of cardiovascular events was 9.8% for letrozole tablets and 7.0% for placebo.

Based on 62 months median duration of follow-up in the randomized letrozole arm in the Safety population the incidence of cardiovascular disease at any time after randomization was 14.4% for letrozole and 9.8% for placebo.

Lipid sub-study: In the extended adjuvant setting, based on a median duration of follow-up of 62 months, there was no significant difference between letrozole and placebo in total cholesterol or in any lipid fraction over 5 years. Use of lipid lowering drugs or dietary management of elevated lipids was allowed. [see Warnings and Precautions(5.2)]

A total of 455 patients were treated for a median time of exposure of 11 months. The incidence of adverse reactions was similar for letrozole and tamoxifen. The most frequently reported adverse reactions were bone pain, hot flushes, back pain, nausea, arthralgia and dyspnea. Discontinuations for adverse reactions other than progression of tumor occurred in 10/455 (2%) of patients on letrozole tablets and in 15/455 (3%) of patients on tamoxifen.

Adverse reactions, regardless of relationship to study drug, that were reported in at least 5% of the patients treated with letrozole tablets 2.5 mg or tamoxifen 20 mg in the first-line treatment study are shown in Table 3.

Other less frequent (≤2%) adverse reactions considered consequential for both treatment groups, included peripheral thromboembolic events, cardiovascular events, and cerebrovascular events. Peripheral thromboembolic events included venous thrombosis, thrombophlebitis, portal vein thrombosis and pulmonary embolism. Cardiovascular events included angina, myocardial infarction, myocardial ischemia, and coronary heart disease. Cerebrovascular events included transient ischemic attacks, thrombotic or hemorrhagic strokes and development of hemiparesis.

Table 3: Percentage (%) of Patients with Adverse Reactions
Adverse
Reaction
Letrozole
2.5 mg
(N=455)
%
tamoxifen
20 mg
(N=455)
%
 General Disorders    
    Fatigue  13  13
    Chest Pain  8  9
    Edema Peripheral  5  6
    Pain NOS  5  7
    Weakness  6  4
 Investigations    
    Weight Decreased  7  5
 Vascular Disorders    
    Hot Flushes  19  16
    Hypertension  8  4
 Gastrointestinal Disorders    
    Nausea  17  17
     Constipation  10  11
    Diarrhea  8  4
    Vomiting  7  8
 Infections/Infestations    
     Influenza  6  4
    Urinary Tract Infection NOS  6  3
 Injury, Poisoning and Procedural Complications    
    Post-Mastectomy Lymphedema  7  7
 Metabolism and Nutrition Disorders    
    Anorexia  4  6
 Musculoskeletal and Connective Tissue Disorders    
    Bone Pain  22  21
    Back Pain  18  19
    Arthralgia  16  15
    Pain in Limb  10  8
 Nervous System Disorders    
    Headache NOS  8  7
 Psychiatric Disorders    
    Insomnia  7  4
 Reproductive System and Breast Disorders    
    Breast Pain  7  7
 Respiratory, Thoracic and Mediastinal Disorders    
    Dyspnea  18  17
    Cough  13  13
    Chest Wall Pain  6  6

Study discontinuations in the megestrol acetate comparison study for adverse reactions other than progression of tumor were 5/188 (2.7%) on letrozole 0.5 mg, in 4/174 (2.3%) on letrozole 2.5 mg, and in 15/190 (7.9%) on megestrol acetate. There were fewer thromboembolic events at both letrozole doses than on the megestrol acetate arm (0.6% vs 4.7%). There was also less vaginal bleeding (0.3% vs 3.2%) on letrozole than on megestrol acetate. In the aminoglutethimide comparison study, discontinuations for reasons other than progression occurred in 6/193 (3.1%) on 0.5 mg letrozole, 7/185 (3.8%) on 2.5 mg letrozole, and 7/178 (3.9%) of patients on aminoglutethimide.

Comparisons

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This randomized phase 2 trial is evaluating superiority of Letrozole-palbociclib combination versus letrozole alone in ER positive endometrioid adenocarcinoma of endometrium

A Study of Neoadjuvant Letrozole + GDC-0032 Versus Letrozole + Placebo in Post-Menopausal Women With Breast Cancer (LORELEI)

This is a two-arm, randomized, double-blind, multicenter, pre-operative study to evaluate the effect of combining letrozole and GDC-0032 versus letrozole and placebo in postmenopausal wome...

Study Evaluating Bosutinib-Letrozole Combination Versus Letrozole Alone in Post Menopausal Women With Breast Cancer

This is a phase 2 study of bosutinib administered in combination with letrozole versus letrozole alone in post-menopausal women with breast cancer. This is a 2-part study. Subjects in part...

PubMed Articles [29 Associated PubMed Articles listed on BioPortfolio]

miR-1271 inhibits ERα expression and confers letrozole resistance in breast cancer.

Attenuation of estrogen receptor α (ERα) expression via unknown mechanism(s) is a hallmark of endocrine-resistant breast cancer (BCa) progression. Here, we report that miR-1271 was significantly dow...

Impact of Palbociclib Plus Letrozole on Patient Reported Health-Related Quality of Life: Results From the PALOMA-2 Trial.

Patient-reported outcomes are integral in benefit-risk assessments of new treatment regimens. The PALOMA-2 study provides the largest body of evidence for patient-reported health-related quality of li...

Aromatase inhibition by letrozole attenuates kainic acid-induced seizures but not neurotoxicity in mice.

Evidence shows neurosteroids play a key role in regulating epileptogenesis. Neurosteroids such as testosterone modulate seizure susceptibility through its transformation to metabolites which show proc...

Acute inhibition of estradiol synthesis impacts vestibulo-ocular reflex adaptation and cerebellar long-term potentiation in male rats.

The vestibulo-ocular reflex (VOR) adaptation is an ideal model for investigating how the neurosteroid 17 beta-estradiol (E2) contributes to the modification of behavior by regulating synaptic activiti...

Patient and tumor characteristics and their influence on early therapy persistence with letrozole in postmenopausal patients with early breast cancer.

Patients' compliance and persistence with endocrine treatment has a significant effect on the prognosis in early breast cancer (EBC). The purpose of this analysis was to identify possible reasons for ...

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