Breast Cancer
Conditions
Keywords
stage IA breast cancer, stage IB breast cancer, stage II breast cancer, stage IIIA breast cancer
Brief summary
RATIONALE: Studying samples of blood in the laboratory from patients receiving treatment for cancer may help doctors learn more about changes that may occur in DNA and identify biomarkers related to cancer. PURPOSE: This clinical trial is studying changes in estrogen levels and grip strength in postmenopausal women who have received 4 to 6 years of hormone therapy for breast cancer and are currently receiving letrozole on clinical trial IBCSG-35-07.
Detailed description
OBJECTIVES: Primary * To determine the serum level of estrogens (Estradiol \[E2\], Estrone \[E1\], and Estrone Sulphate \[E1S\] and sex hormone binding globulin \[SHBG\]) in postmenopausal women with prior endocrine-responsive, node-positive, resectable breast cancer completing 4 to 6 years of adjuvant endocrine therapy and enrolled on clinical trial IBCSG-35-07 receiving letrozole. * To determine the degree of recovery of E2, E1, and E1S during the 3-month letrozole-off gap. Secondary * To determine the association between estrogen level changes and the clinical outcomes of toxicity and quality of life. * To determine the effect of prior adjuvant endocrine therapy, age, body mass index, and type of menopause on estrogen levels. * To determine the variability of estrogen level changes and its association with germline single nucleotide polymorphisms. * To examine changes in grip-strength score. OUTLINE: This is a multicenter study. All patients undergo blood sample collection at baseline for the analysis of single nucleotide polymorphisms, after randomization on clinical trial IBCSG-35-07 and prior to the beginning treatment on IBCSG-35-07. Patients also undergo serum collection at baseline and at 9, 10.5, and 12 months for the analysis of estrogen levels and sex hormone binding globulins. Patients undergo measurement of grip strength at baseline and at 9 and 12 months. Samples may be banked for future research studies. Patients complete quality-of-life questionnaires (Breast Cancer Prevention Trial \[BCPT\] Symptom Scales on Form 35-PRS and IBCSG Trial 35-07 QL Form) periodically.
Interventions
OTHERlaboratory biomarker analysis
Biomarkers will be assessed in blood and serum samples at different time points.
GENETICpolymorphism analysis
SNPs will be genotyped in whole blood samples taken at baseline.
PROCEDUREquality-of-life assessment
Quality of life will be assessed using the Breast Cancer Prevention Trial (BCPT) Symptom Scales and the IBCSG Trial 35-07 QL Form.
Sponsors
ETOP IBCSG Partners Foundation
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 120 Years
Healthy volunteers
No
Inclusion criteria
DISEASE CHARACTERISTICS: * Previously diagnosed with breast cancer * Endocrine-responsive, node-positive, resectable disease * Disease-free following 4-6 years of prior adjuvant endocrine therapy with selective estrogen-receptor modulators and/or aromatase inhibitors * Patient must be currently enrolled on clinical trial IBCSG-35-07 as well as the Quality-of-Life substudy * Hormone receptor status not specified PATIENT CHARACTERISTICS: * Postmenopausal PRIOR CONCURRENT THERAPY: * See Disease Characteristics
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Levels of Estrone (E1), Estradiol (E2), and Estrone Sulphate (E1S) Among Patients in the Longitudinal Analysis Population | 0 (baseline), 9, 10.5, and 12 months from randomization | In SOLE-EST, levels of E1, E2, and E1S were summarized over time at 0 (baseline), 9, 10.5, and 12 months from randomization among patients in the longitudinal analysis population (N=90 with post-baseline sample). |
| Percent Change of E1, E2, and E1S Levels at 9, 10.5, and 12 Months From Baseline, by Treatment Group | 9, 10.5, and 12 months from baseline | Changes in hormone levels (E1, E2, and E1S levels), as percentage change over time according to treatment assignment (at 9, 10.5 and 12 months from baseline). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Toxicity Grade Changes for Arthralgia, Hot Flushes, and Insomnia | 6 and 12 months | Toxicity grade changes from 6 to 12 months (hot flashes, insomnia and arthralgia; Common Terminology Criteria for Adverse Events (CTCAE) version 3 values 1- 4 grouped as no change, increase in grade \[worsening\] or decrease in grade \[improvement\]) |
| Quality of Life (QoL) Score Changes | 6 and 12 months: Change is calculated from 12 months minus 6 months, therefore positive values indicate an improved condition and negative values indicate a declined condition | All patients in SOLE-EST were assessed for symptom specific QoL. QoL changes from 6 to 12 months (sleep change, hot flushes, tiredness, difficulties of becoming aroused, loss of sexual interest, physical wellbeing and mood; LASA (linear analogue self-assessment) scores 0-100 (higher is better QoL) were calculated as 12 months minus 6 months, so that negative is worsening and positive is improvement. |
| Change in Grip-strength Score in the Dominant Hand | Changes in grip strength score is calculated at 12 months minus 9 months | Grip strength was measured using the Martin Vigorimeter (a modified sphygmomanometer which measures the force of compression in kilo pascal by means of a compressible rubber ball). To perform the hand grip test, the patients were asked to squeeze the ball of a modified sphygmomanometer three times with maximal force and the maximal value of three trials of each hand were used for evaluation. Higher value represents greater strength, thus changes are calculated as 12 months minus 9 months so that positive is improved condition and negative is declined condition. |
Countries
Australia, Belgium
Participant flow
Recruitment details
The phase 3 randomized, open-label Study of Letrozole Extension (SOLE) enrolled 4884 postmenopausal women between December 2007 and October 2012. Among them, 104 patients were enrolled in the SOLE Estrogen Substudy (SOLE-EST). SOLE was a multinational study performed in 240 centers of the Breast International Group-affiliated cooperative groups in 22 countries.
Pre-assignment details
There were 104 patients enrolled during the active period (25 continuous letrozole, 79 intermittent letrozole). Blood samples were obtained from 103 patients at baseline. For the longitudinal analysis, patients (N=90) were included if they had at least one post-baseline sample. At 9, 10.5, and 12 months, 85 (21 continuous, 64 intermittent), 84 (20 continuous, 64 intermittent) and 81 (19 continuous, 62 intermittent), patients, respectively, could be included in longitudinal analyses.
Participants by arm
| Arm | Count |
|---|---|
| Continuous Letrozole Treatment Group Patients were randomized 1:1 for SOLE and enrolled in 1:3 ratio for SOLE-EST between continuous letrozole (2.5 mg/day orally for 5 years) and intermittent letrozole treatment (2.5 mg/day during 9 months followed by a 3 month interruption in years 1-4 and then 2.5 mg/day during all year 5). | 25 |
| Intermittent Letrozole Treatment Group Patients were randomized 1:1 for SOLE and enrolled in 1:3 ratio for SOLE-EST between continuous letrozole (2.5 mg/day orally for 5 years) and intermittent letrozole treatment (2.5 mg/day during 9 months followed by a 3 month interruption in years 1-4 and then 2.5 mg/day during all year 5). | 78 |
| Total | 103 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Analysis Population (10.5 Months) | 1 from the baseline analysis population did not have a sample assayed for analysis at month 10.5 | 1 | 0 |
| Analysis Population (12 Months) | 3 from the baseline analysis population did not have a sample assayed for analysis at month 12 | 1 | 2 |
| Analysis Population (9 Months) | 5 from the baseline analysis population did not have samples assayed for the analysis at month 9. | 0 | 5 |
| Analysis Population (Baseline) | baseline sample only so excluded from longitudinal analysis | 4 | 9 |
| Baseline Population | No samples assayed (excluded from all analyses) | 0 | 1 |
Baseline characteristics
| Characteristic | Continuous Letrozole Treatment Group | Intermittent Letrozole Treatment Group | Total |
|---|---|---|---|
| Age, Customized Age at randomization, years <55 | 6 Participants | 23 Participants | 29 Participants |
| Age, Customized Age at randomization, years 55-59 | 6 Participants | 13 Participants | 19 Participants |
| Age, Customized Age at randomization, years 60-64 | 3 Participants | 15 Participants | 18 Participants |
| Age, Customized Age at randomization, years 65-69 | 5 Participants | 12 Participants | 17 Participants |
| Age, Customized Age at randomization, years ≥70 | 5 Participants | 15 Participants | 20 Participants |
| Body Mass Index (BMI) at randomization Normal (<25) | 12 Participants | 27 Participants | 39 Participants |
| Body Mass Index (BMI) at randomization Obese (≥30) | 6 Participants | 20 Participants | 26 Participants |
| Body Mass Index (BMI) at randomization Overweight (25-<30) | 7 Participants | 31 Participants | 38 Participants |
| Body Mass Index (BMI) at randomization Unknown | 0 Participants | 0 Participants | 0 Participants |
| Duration from end of prior ET to randomization ≤ 1 month | 20 Participants | 61 Participants | 81 Participants |
| Duration from end of prior ET to randomization >1 month | 5 Participants | 17 Participants | 22 Participants |
| Duration of prior AI 2 - <3 years | 5 Participants | 14 Participants | 19 Participants |
| Duration of prior AI 3 - <4 years | 3 Participants | 10 Participants | 13 Participants |
| Duration of prior AI ≥4 years | 15 Participants | 46 Participants | 61 Participants |
| Duration of prior AI <6 months | 2 Participants | 5 Participants | 7 Participants |
| Duration of prior AI 6 months - <2 years | 0 Participants | 3 Participants | 3 Participants |
| Duration of prior AI Unknown | 0 Participants | 0 Participants | 0 Participants |
| Last (most recent) type of prior endocrine therapy (ET) Aromatase inhibitor (AI) | 23 Participants | 72 Participants | 95 Participants |
| Last (most recent) type of prior endocrine therapy (ET) Selective estrogen receptor modulators (SERM) | 2 Participants | 6 Participants | 8 Participants |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Sex: Female, Male Female | 25 Participants | 78 Participants | 103 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
| Type of menopause Bilateral oophorectomy | 4 Participants | 22 Participants | 26 Participants |
| Type of menopause Chemotherapy-induced amenorrhea | 7 Participants | 8 Participants | 15 Participants |
| Type of menopause Natural menopause before breast cancer diagnosis | 13 Participants | 41 Participants | 54 Participants |
| Type of menopause Natural menopause since breast cancer diagnosis | 1 Participants | 7 Participants | 8 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 25 | 0 / 78 |
| other Total, other adverse events | 0 / 25 | 0 / 78 |
| serious Total, serious adverse events | 0 / 25 | 0 / 78 |
Outcome results
Primary
Levels of Estrone (E1), Estradiol (E2), and Estrone Sulphate (E1S) Among Patients in the Longitudinal Analysis Population
In SOLE-EST, levels of E1, E2, and E1S were summarized over time at 0 (baseline), 9, 10.5, and 12 months from randomization among patients in the longitudinal analysis population (N=90 with post-baseline sample).
Time frame: 0 (baseline), 9, 10.5, and 12 months from randomization
Population: Longitudinal analysis group: There were 90/103 patients (21 continuous, 69 intermittent) who had baseline and one or more samples at 9, 10.5 and/or 12 months and could be included in analyses of hormone levels over time. At 9, 10.5, and 12 months, 85, 84, and 81, respectively, could be included in analyses of hormone levels over time.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Continuous Letrozole Treatment Group (Baseline, Month 0) | Levels of Estrone (E1), Estradiol (E2), and Estrone Sulphate (E1S) Among Patients in the Longitudinal Analysis Population | E1 | 12.4 pg/mL |
| Continuous Letrozole Treatment Group (Baseline, Month 0) | Levels of Estrone (E1), Estradiol (E2), and Estrone Sulphate (E1S) Among Patients in the Longitudinal Analysis Population | E1S | 90.7 pg/mL |
| Continuous Letrozole Treatment Group (Baseline, Month 0) | Levels of Estrone (E1), Estradiol (E2), and Estrone Sulphate (E1S) Among Patients in the Longitudinal Analysis Population | E2 | 4.6 pg/mL |
| Intermittent Letrozole Treatment Group (Baseline, Month 0) | Levels of Estrone (E1), Estradiol (E2), and Estrone Sulphate (E1S) Among Patients in the Longitudinal Analysis Population | E1S | 87.6 pg/mL |
| Intermittent Letrozole Treatment Group (Baseline, Month 0) | Levels of Estrone (E1), Estradiol (E2), and Estrone Sulphate (E1S) Among Patients in the Longitudinal Analysis Population | E2 | 4.7 pg/mL |
| Intermittent Letrozole Treatment Group (Baseline, Month 0) | Levels of Estrone (E1), Estradiol (E2), and Estrone Sulphate (E1S) Among Patients in the Longitudinal Analysis Population | E1 | 14.3 pg/mL |
| Continuous Letrozole Treatment Group (9 Months) | Levels of Estrone (E1), Estradiol (E2), and Estrone Sulphate (E1S) Among Patients in the Longitudinal Analysis Population | E1S | 61.1 pg/mL |
| Continuous Letrozole Treatment Group (9 Months) | Levels of Estrone (E1), Estradiol (E2), and Estrone Sulphate (E1S) Among Patients in the Longitudinal Analysis Population | E1 | 4.8 pg/mL |
| Continuous Letrozole Treatment Group (9 Months) | Levels of Estrone (E1), Estradiol (E2), and Estrone Sulphate (E1S) Among Patients in the Longitudinal Analysis Population | E2 | 2.6 pg/mL |
| Intermittent Letrozole Treatment Group (9 Months) | Levels of Estrone (E1), Estradiol (E2), and Estrone Sulphate (E1S) Among Patients in the Longitudinal Analysis Population | E1 | 5.1 pg/mL |
| Intermittent Letrozole Treatment Group (9 Months) | Levels of Estrone (E1), Estradiol (E2), and Estrone Sulphate (E1S) Among Patients in the Longitudinal Analysis Population | E2 | 3.2 pg/mL |
| Intermittent Letrozole Treatment Group (9 Months) | Levels of Estrone (E1), Estradiol (E2), and Estrone Sulphate (E1S) Among Patients in the Longitudinal Analysis Population | E1S | 54.1 pg/mL |
| Continuous Letrozole Treatment Group (10.5 Months) | Levels of Estrone (E1), Estradiol (E2), and Estrone Sulphate (E1S) Among Patients in the Longitudinal Analysis Population | E2 | 2.6 pg/mL |
| Continuous Letrozole Treatment Group (10.5 Months) | Levels of Estrone (E1), Estradiol (E2), and Estrone Sulphate (E1S) Among Patients in the Longitudinal Analysis Population | E1 | 4.7 pg/mL |
| Continuous Letrozole Treatment Group (10.5 Months) | Levels of Estrone (E1), Estradiol (E2), and Estrone Sulphate (E1S) Among Patients in the Longitudinal Analysis Population | E1S | 57.1 pg/mL |
| Intermittent Letrozole Treatment Group (10.5 Months) | Levels of Estrone (E1), Estradiol (E2), and Estrone Sulphate (E1S) Among Patients in the Longitudinal Analysis Population | E2 | 6.7 pg/mL |
| Intermittent Letrozole Treatment Group (10.5 Months) | Levels of Estrone (E1), Estradiol (E2), and Estrone Sulphate (E1S) Among Patients in the Longitudinal Analysis Population | E1 | 21.6 pg/mL |
| Intermittent Letrozole Treatment Group (10.5 Months) | Levels of Estrone (E1), Estradiol (E2), and Estrone Sulphate (E1S) Among Patients in the Longitudinal Analysis Population | E1S | 128.6 pg/mL |
| Continuous Letrozole Treatment Group (12 Months) | Levels of Estrone (E1), Estradiol (E2), and Estrone Sulphate (E1S) Among Patients in the Longitudinal Analysis Population | E2 | 2.9 pg/mL |
| Continuous Letrozole Treatment Group (12 Months) | Levels of Estrone (E1), Estradiol (E2), and Estrone Sulphate (E1S) Among Patients in the Longitudinal Analysis Population | E1 | 5.1 pg/mL |
| Continuous Letrozole Treatment Group (12 Months) | Levels of Estrone (E1), Estradiol (E2), and Estrone Sulphate (E1S) Among Patients in the Longitudinal Analysis Population | E1S | 59.1 pg/mL |
| Intermittent Letrozole Treatment Group (12 Months) | Levels of Estrone (E1), Estradiol (E2), and Estrone Sulphate (E1S) Among Patients in the Longitudinal Analysis Population | E1 | 26.8 pg/mL |
| Intermittent Letrozole Treatment Group (12 Months) | Levels of Estrone (E1), Estradiol (E2), and Estrone Sulphate (E1S) Among Patients in the Longitudinal Analysis Population | E2 | 7.3 pg/mL |
| Intermittent Letrozole Treatment Group (12 Months) | Levels of Estrone (E1), Estradiol (E2), and Estrone Sulphate (E1S) Among Patients in the Longitudinal Analysis Population | E1S | 125.1 pg/mL |
Primary
Percent Change of E1, E2, and E1S Levels at 9, 10.5, and 12 Months From Baseline, by Treatment Group
Changes in hormone levels (E1, E2, and E1S levels), as percentage change over time according to treatment assignment (at 9, 10.5 and 12 months from baseline).
Time frame: 9, 10.5, and 12 months from baseline
Population: Longitudinal Analysis Population: There were 90/103 patients (21 continuous, 69 intermittent) who had baseline and one or more samples at 9, 10.5 and/or 12 months and could be included in analyses of hormone levels over time. 90 patients at baseline, 85 patients at month 9, 84 patients at month 10.5, and 81 patients at month 12.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Continuous Letrozole Treatment Group (Baseline, Month 0) | Percent Change of E1, E2, and E1S Levels at 9, 10.5, and 12 Months From Baseline, by Treatment Group | Percent change of E2 | -34.2 percentage change |
| Continuous Letrozole Treatment Group (Baseline, Month 0) | Percent Change of E1, E2, and E1S Levels at 9, 10.5, and 12 Months From Baseline, by Treatment Group | Percent change of E1 | -58.2 percentage change |
| Continuous Letrozole Treatment Group (Baseline, Month 0) | Percent Change of E1, E2, and E1S Levels at 9, 10.5, and 12 Months From Baseline, by Treatment Group | Percent change of ES1 | -29.8 percentage change |
| Intermittent Letrozole Treatment Group (Baseline, Month 0) | Percent Change of E1, E2, and E1S Levels at 9, 10.5, and 12 Months From Baseline, by Treatment Group | Percent change of E2 | -32.2 percentage change |
| Intermittent Letrozole Treatment Group (Baseline, Month 0) | Percent Change of E1, E2, and E1S Levels at 9, 10.5, and 12 Months From Baseline, by Treatment Group | Percent change of E1 | -59.3 percentage change |
| Intermittent Letrozole Treatment Group (Baseline, Month 0) | Percent Change of E1, E2, and E1S Levels at 9, 10.5, and 12 Months From Baseline, by Treatment Group | Percent change of ES1 | -42.3 percentage change |
| Continuous Letrozole Treatment Group (9 Months) | Percent Change of E1, E2, and E1S Levels at 9, 10.5, and 12 Months From Baseline, by Treatment Group | Percent change of E2 | -39.6 percentage change |
| Continuous Letrozole Treatment Group (9 Months) | Percent Change of E1, E2, and E1S Levels at 9, 10.5, and 12 Months From Baseline, by Treatment Group | Percent change of E1 | -67.3 percentage change |
| Continuous Letrozole Treatment Group (9 Months) | Percent Change of E1, E2, and E1S Levels at 9, 10.5, and 12 Months From Baseline, by Treatment Group | Percent change of ES1 | -38.7 percentage change |
| Intermittent Letrozole Treatment Group (9 Months) | Percent Change of E1, E2, and E1S Levels at 9, 10.5, and 12 Months From Baseline, by Treatment Group | Percent change of E2 | 62.7 percentage change |
| Intermittent Letrozole Treatment Group (9 Months) | Percent Change of E1, E2, and E1S Levels at 9, 10.5, and 12 Months From Baseline, by Treatment Group | Percent change of E1 | 76.6 percentage change |
| Intermittent Letrozole Treatment Group (9 Months) | Percent Change of E1, E2, and E1S Levels at 9, 10.5, and 12 Months From Baseline, by Treatment Group | Percent change of ES1 | 32.9 percentage change |
| Continuous Letrozole Treatment Group (10.5 Months) | Percent Change of E1, E2, and E1S Levels at 9, 10.5, and 12 Months From Baseline, by Treatment Group | Percent change of E2 | -47.7 percentage change |
| Continuous Letrozole Treatment Group (10.5 Months) | Percent Change of E1, E2, and E1S Levels at 9, 10.5, and 12 Months From Baseline, by Treatment Group | Percent change of E1 | -57.8 percentage change |
| Continuous Letrozole Treatment Group (10.5 Months) | Percent Change of E1, E2, and E1S Levels at 9, 10.5, and 12 Months From Baseline, by Treatment Group | Percent change of ES1 | -36.7 percentage change |
| Intermittent Letrozole Treatment Group (10.5 Months) | Percent Change of E1, E2, and E1S Levels at 9, 10.5, and 12 Months From Baseline, by Treatment Group | Percent change of E1 | 68.7 percentage change |
| Intermittent Letrozole Treatment Group (10.5 Months) | Percent Change of E1, E2, and E1S Levels at 9, 10.5, and 12 Months From Baseline, by Treatment Group | Percent change of ES1 | 31.6 percentage change |
| Intermittent Letrozole Treatment Group (10.5 Months) | Percent Change of E1, E2, and E1S Levels at 9, 10.5, and 12 Months From Baseline, by Treatment Group | Percent change of E2 | 46.2 percentage change |
Secondary
Change in Grip-strength Score in the Dominant Hand
Grip strength was measured using the Martin Vigorimeter (a modified sphygmomanometer which measures the force of compression in kilo pascal by means of a compressible rubber ball). To perform the hand grip test, the patients were asked to squeeze the ball of a modified sphygmomanometer three times with maximal force and the maximal value of three trials of each hand were used for evaluation. Higher value represents greater strength, thus changes are calculated as 12 months minus 9 months so that positive is improved condition and negative is declined condition.
Time frame: Changes in grip strength score is calculated at 12 months minus 9 months
Population: Longitudinal analysis population N=90 (21 Continuous letrozole; 69 Intermittent letrozole); N samples per timepoint: N=90 at baseline, N=85 at month 9; N= 84 at month 10.5, N=81 at month 12. In total, 76/85 patients (19 continuous; 57 intermittent) who had a 9 month sample also had a sample at 12 months and are included in analyses relating E2 change (9 to 12m) with grip strength.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Continuous Letrozole Treatment Group (Baseline, Month 0) | Change in Grip-strength Score in the Dominant Hand | -1.0 kilopascals |
| Intermittent Letrozole Treatment Group (Baseline, Month 0) | Change in Grip-strength Score in the Dominant Hand | 0.0 kilopascals |
Secondary
Quality of Life (QoL) Score Changes
All patients in SOLE-EST were assessed for symptom specific QoL. QoL changes from 6 to 12 months (sleep change, hot flushes, tiredness, difficulties of becoming aroused, loss of sexual interest, physical wellbeing and mood; LASA (linear analogue self-assessment) scores 0-100 (higher is better QoL) were calculated as 12 months minus 6 months, so that negative is worsening and positive is improvement.
Time frame: 6 and 12 months: Change is calculated from 12 months minus 6 months, therefore positive values indicate an improved condition and negative values indicate a declined condition
Population: In total, 76/85 patients (19 continuous; 57 intermittent) who had a 6 month sample also had a sample at 12 months and are included in analyses relating E2 change (6 to 12m) with QL, grip strength and AE changes.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Continuous Letrozole Treatment Group (Baseline, Month 0) | Quality of Life (QoL) Score Changes | LASA difficulty becoming aroused score change from 12 to 6 months | 0.5 score on a scale |
| Continuous Letrozole Treatment Group (Baseline, Month 0) | Quality of Life (QoL) Score Changes | LASA sleep disturbance score change from 12 to 6 months | 0.0 score on a scale |
| Continuous Letrozole Treatment Group (Baseline, Month 0) | Quality of Life (QoL) Score Changes | LASA loss of sexual interest score change from 12 to 6 months | -3.0 score on a scale |
| Continuous Letrozole Treatment Group (Baseline, Month 0) | Quality of Life (QoL) Score Changes | LASA tiredness score change from 12 to 6 months | -1.0 score on a scale |
| Continuous Letrozole Treatment Group (Baseline, Month 0) | Quality of Life (QoL) Score Changes | LASA physical well-being score change from 12 to 6 months | -1.0 score on a scale |
| Continuous Letrozole Treatment Group (Baseline, Month 0) | Quality of Life (QoL) Score Changes | LASA mood score change from 12 to 6 months | 0.0 score on a scale |
| Continuous Letrozole Treatment Group (Baseline, Month 0) | Quality of Life (QoL) Score Changes | LASA hot flush score change from 12 to 6 months | 2.0 score on a scale |
| Intermittent Letrozole Treatment Group (Baseline, Month 0) | Quality of Life (QoL) Score Changes | LASA mood score change from 12 to 6 months | -1.0 score on a scale |
| Intermittent Letrozole Treatment Group (Baseline, Month 0) | Quality of Life (QoL) Score Changes | LASA sleep disturbance score change from 12 to 6 months | -9.5 score on a scale |
| Intermittent Letrozole Treatment Group (Baseline, Month 0) | Quality of Life (QoL) Score Changes | LASA hot flush score change from 12 to 6 months | -2.0 score on a scale |
| Intermittent Letrozole Treatment Group (Baseline, Month 0) | Quality of Life (QoL) Score Changes | LASA tiredness score change from 12 to 6 months | -9.0 score on a scale |
| Intermittent Letrozole Treatment Group (Baseline, Month 0) | Quality of Life (QoL) Score Changes | LASA difficulty becoming aroused score change from 12 to 6 months | 0.0 score on a scale |
| Intermittent Letrozole Treatment Group (Baseline, Month 0) | Quality of Life (QoL) Score Changes | LASA loss of sexual interest score change from 12 to 6 months | -1.5 score on a scale |
| Intermittent Letrozole Treatment Group (Baseline, Month 0) | Quality of Life (QoL) Score Changes | LASA physical well-being score change from 12 to 6 months | -5.0 score on a scale |
Secondary
Toxicity Grade Changes for Arthralgia, Hot Flushes, and Insomnia
Toxicity grade changes from 6 to 12 months (hot flashes, insomnia and arthralgia; Common Terminology Criteria for Adverse Events (CTCAE) version 3 values 1- 4 grouped as no change, increase in grade \[worsening\] or decrease in grade \[improvement\])
Time frame: 6 and 12 months
Population: In total, 76/85 patients (19 continuous; 57 intermittent) who had a 9 month sample also had a sample at 12 months and are included in analyses relating E2 change (9 to 12m) with QL, grip strength and adverse event (AE) changes.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Continuous Letrozole Treatment Group (Baseline, Month 0) | Toxicity Grade Changes for Arthralgia, Hot Flushes, and Insomnia | AE: Hot Flushes Grade Change from 6 to 12 Months | 0.0 toxicity grade |
| Continuous Letrozole Treatment Group (Baseline, Month 0) | Toxicity Grade Changes for Arthralgia, Hot Flushes, and Insomnia | AE: Insomnia Grade Change from 6 to 12 Months | 0.0 toxicity grade |
| Continuous Letrozole Treatment Group (Baseline, Month 0) | Toxicity Grade Changes for Arthralgia, Hot Flushes, and Insomnia | AE: Arthralgia Grade Change from 6 to 12 Months | 0.0 toxicity grade |
| Intermittent Letrozole Treatment Group (Baseline, Month 0) | Toxicity Grade Changes for Arthralgia, Hot Flushes, and Insomnia | AE: Hot Flushes Grade Change from 6 to 12 Months | 0.0 toxicity grade |
| Intermittent Letrozole Treatment Group (Baseline, Month 0) | Toxicity Grade Changes for Arthralgia, Hot Flushes, and Insomnia | AE: Insomnia Grade Change from 6 to 12 Months | 0.0 toxicity grade |
| Intermittent Letrozole Treatment Group (Baseline, Month 0) | Toxicity Grade Changes for Arthralgia, Hot Flushes, and Insomnia | AE: Arthralgia Grade Change from 6 to 12 Months | 0.0 toxicity grade |