A Phase 3 interventional study of Tamoxifen and Exemestane in Breast Neoplasms, sponsored by Pfizer. Completed at 380 sites in 37 countries. Open to female participants aged 30 Years and older. Per ClinicalTrials.gov, last updated 2014-05-07.
Sponsored by Pfizer · Phase 3, Interventional, and Treatment
To compare the sequential administration of exemestane with administration of further tamoxifen until 5 years in postmenopausal women with operable breast cancer who have already received 2-3 years of adjuvant tamoxifen, in terms of disease-free survival (DFS), overall survival (OS), incidence of contralateral breast cancer and long-term tolerability.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug: Tamoxifen
Drug: Exemestane
Tamoxifen 20 mg/day tablets administered p.o. for a period ranging from 2.5 to 3 years.
Exemestane 25 mg/day tablets administered p.o. for a period ranging from 2.5 to 3 years.
Disease-Free Survival (DFS) at Month 36 Post-Randomization: Main Study
DFS defined as time from randomization to earliest documentation of breast cancer relapse or death from any cause. DFS at Month 36 post-randomization was defined as probability of participants alive and disease-free at 36 months after the randomization. Participants withdrawn from the study for any reason in the absence of relapse were censored at the date they were last seen. Relapse was categorized as follows: loco-regional: ipsilateral breast or axillary nodal relapse; distant: distant relapse, including supraclavicular nodes; second primary breast cancer: contralateral breast cancer, excluding ductal carcinoma in situ.
Time frame: Baseline up to Month 36
Overall Survival (OS) at Month 36 Post-Randomization: Main Study
OS was defined as the duration from randomization to death (due to any cause). OS at Month 36 post-randomization was defined as probability of participants' survival at 36 months after the randomization. For participants who were alive, OS was censored at the last available assessment. Probability of OS at Month 36 post-randomization was reported using Kaplan-Meier estimates at Month 36 post-randomization based on 120-month follow-up data.
Time frame: Baseline up to Month 120
Number of Events of Second Breast Cancer in Contralateral Breast: Main Study
Number of events of second primary breast cancer in contralateral breast (excluding ductal carcinoma in situ) were reported.
Time frame: Baseline up to Month 120
Percent Change From Baseline in Lumbar Spine and Proximal Femur (Total Hip) Bone Mineral Density (BMD) at 6, 12, 24 Months On-treatment and 24 Months Post-treatment: Bone Metabolism Sub-study
BMD measurements for Lumbar spine (LS) and Proximal Femur (Total Hip \[TH\]) were performed using dual energy X-ray absorptiometry (DXA) for participants who entered the bone-metabolism sub-study. 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure and 'n' signifies those participants who were evaluable for this measure at given time points for each group, respectively.
Time frame: Baseline, 6, 12, 24 months after randomization (on-treatment), 24 months post-treatment
Percent Change From Baseline in Femoral Neck and Femoral Wards Bone Mineral Density (BMD) at 6, 12 and 24 Months On-treatment and 24 Months Post-treatment: Bone Metabolism Sub-study
BMD measurements for femoral neck (FN) and femoral wards (FW) were performed using dual energy X-ray absorptiometry (DXA) for participants who entered the bone-metabolism sub-study. 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure and 'n' signifies those participants who were evaluable for this measure at given time points for each group, respectively.
Time frame: Baseline, 6, 12, 24 months after randomization (on-treatment), 24 months post-treatment
Change From Baseline in Lumbar Spine and Proximal Femur (Total Hip) Bone Mineral Density (BMD) T-scores at 6, 12 and 24 Months On-treatment and 24 Months Post-treatment: Bone Metabolism Sub-study
BMD measurements for Lumbar spine (LS) and Proximal Femur (Total Hip \[TH\]) were performed using dual energy X-ray absorptiometry (DXA) for participants who entered the bone-metabolism sub-study. Results were scored as T-score. T-score indicated how many standard deviations higher or lower participant's value was when compared to the young normal reference mean. Using the World Health Organization (WHO) criteria for osteoporosis, a T-score of greater than or equal to (\>=)-1.0 was classified as normal, a T-score of greater than -2.5 to less than -1.0 as osteopenic, and a T-score less than or equal to (\<=)-2.5 as osteoporotic. Here 'n' signifies those participants who were evaluable for this measure at given time points for each group, respectively.
Time frame: Baseline, 6, 12, 24 months after randomization (on-treatment), 24 months post-treatment
Percentage of Bone Specific Alkaline Phosphatase (BAP) Serum Concentration Relative to Baseline: Bone Metabolism Sub-study
Bone specific alkaline phosphatase (BAP) serum concentration analyzed using enzyme immuno assay (EIA) at post-baseline time points was expressed as percentage of baseline BAP serum concentration. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure and 'n' signifies those participants who were evaluable for this measure at given time points for each group, respectively.
Time frame: Baseline, 3, 6, 9, 12, 18, 24, 30 months after randomization (on-treatment), 36 months after randomization (end of treatment), 12, 24 months post-treatment
Percentage of C-Terminal Telopeptide (CTX) Serum Concentration Relative to Baseline: Bone Metabolism Sub-study
C-terminal telopeptide (CTX) serum concentration analyzed using competitive enzyme-linked immunosorbent assay (ELISA) at post-baseline time points was expressed as percentage of baseline CTX serum concentration. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure and 'n' signifies those participants who were evaluable for this measure at given time points for each group, respectively.
Time frame: Baseline, 3, 6, 9, 12, 18, 24, 30 months after randomization (on-treatment), 36 months after randomization (end of treatment), 12, 24 months post-treatment
Percentage of Osteocalcin (OC) and Procollagen T1 C-Peptide (PICP) Serum Concentration Relative to Baseline: Bone Metabolism Sub-study
Osteocalcin (OC) serum concentration analyzed using ELISA and procollagen T1 c-peptide (PICP) serum concentration analyzed using sandwich EIA at post-baseline time points was expressed as percentage of baseline OC serum concentration and baseline PICP serum concentration, respectively. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure and 'n' signifies those participants who were evaluable for this measure at given time points, for each group respectively.
Time frame: Baseline, 3, 6, 9, 12, 18, 24, 30 months after randomization (on-treatment), 36 months after randomization (end of treatment), 12, 24 months post-treatment
Percentage of Deoxy-pyridinoline (DPD) Urine Concentration Relative to Baseline: Bone Metabolism Sub-study
Deoxy-pyridinoline (DPD) urine concentration (adjusted for urinary creatinine) analyzed using competitive EIA at post-baseline time points was expressed as percentage of baseline DPD urine concentration. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure and 'n' signifies those participants who were evaluable for this measure at given time points for each group, respectively.
Time frame: Baseline, 3, 6, 9, 12, 18, 24, 30 months after randomization (on-treatment), 36 months after randomization (end of treatment), 12, 24 months post-treatment
Percentage of N-telopeptide of Type 1 Collagen (NTX) Urine Concentration Relative to Baseline: Bone Metabolism Sub-study
N-telopeptide of Type 1 collagen (NTX) urine concentration (adjusted for urinary creatinine) analyzed using competitive inhibition EIA at post-baseline time points was expressed as percentage of baseline NTX urine concentration. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure and 'n' signifies those participants who were evaluable for this measure at given time points for each group, respectively.
Time frame: Baseline, 3, 6, 9, 12, 18, 24, 30 months after randomization (on-treatment), 36 months after randomization (end of treatment), 12, 24 months post-treatment
Number of Participants With Fracture: Bone Metabolism Sub-study
Time frame: Baseline up to 24 months post-treatment
Change From Baseline in Treatment Outcome Index (TOI) at 3, 6, 9, 12, 18, 24, 30, 36, 48 and 60 Months: QoL Sub-study
The TOI was defined as the sum of 23 items based on following Functional Assessment of Cancer Therapy - Breast version \[FACT-B\] subscales: Physical well-being (7 items), Functional well-being (7 items), Breast cancer subscale (9 items). Each item was scaled from 0='Not at all' to 4='Very much'. Total TOI score ranged from 0 to 92, where higher TOI score indicated better health-related quality of life (QoL). A change of five points in the TOI scores was considered clinically meaningful. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure and 'n' signifies those participants who were evaluable for this measure at given time points for each group, respectively. Results for 30, 36, 48, 60 months were not reported because data for these time points was only summarized as graphical presentation.
Time frame: Baseline, 3, 6, 9, 12, 18, 24, 30, 36, 48, 60 months after randomization
Change From Baseline in Functional Assessment of Cancer Therapy - Endocrine Subscale (FACT-ES) Total Score at 3, 6, 9, 12, 18, 24, 30, 36, 48 and 60 Months: QoL Sub-study
The FACT-ES assessed health-related QoL in participants with breast cancer. ES subscale comprised of 18 items (hot flushes,cold sweats,night sweats, vaginal discharge,vaginal irritation,vaginal bleeding,vaginal dryness,discomfort with intercourse,lost interest in sex,gained weight,light headed/dizzy,vomiting,had diarrhea,headaches,felt bloated,breast tenderness,mood swings, felt irritable).Participants indicated how true a statement was for them using a 5-point scale from 0 (not at all) to 4 (very much). For items that were negatively framed, the scores were reversed for the analysis so that higher scores equated to a good QoL. Total FACT-ES score was calculated as sum of all the 18 items and ranged from 0 to 72, where higher score indicated better QoL. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure and 'n' signifies those participants who were evaluable for this measure at given time points for each group, respectively.
Time frame: Baseline, 3, 6, 9, 12, 18, 24, 30, 36, 48, 60 months after randomization
Change From Baseline in Total Functional Assessment of Cancer Therapy - General Breast and Endocrine (FACT-GBE) Score at 3, 6, 9, 12, 18, 24, 30, 36, 48 and 60 Months: QoL Sub-study
FACT-GBE assessed health-related quality of life (QoL) in participants with breast cancer. It consisted of 56 items,summarized to 7 subscales(subscale 1 to 6 constituted total FACT-B and subscale 7 constituted total ES):physical well-being(7 items), social/family well-being(7 items),relationship with doctor (2 items),emotional well-being(6 items),functional well-being(7 items),breast cancer subscale(9 items),endocrine symptoms(18 items). Participants indicated how true a statement had been for them using 5-point scale from 0(not at all) to 4(very much). For items that were negatively framed,scores were reversed for analysis so that higher scores equated to good QoL. Total FACT-GBE score=sum of all 56 items(range 0 to 224, where higher score indicated better QoL. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure and 'n' signifies those participants who were evaluable for this measure at given time points for each group, respectively.
Time frame: Baseline, 3, 6, 9, 12, 18, 24, 30, 36, 48, 60 months after randomization
Change From Baseline in Physical Well-Being (PWB) Subscale Score at 3, 6, 9, 12, 18, 24, 30, 36, 48 and 60 Months: QoL Sub-study
The PWB subscale assessed physical well-being related QoL in participants with breast cancer. PWB subscale comprised of 7 items (energy lack, nausea, family needs, pain, side effects, felt ill, forced to stay in bed). Participants indicated how true a statement had been for them using a 5-point scale from 0 (not at all) to 4 (very much). For items that were negatively framed, the scores were reversed for the analysis so that higher scores equated to a good QoL. Total PWB score was calculated as the sum of all the 7 items and ranged from 0 to 28, where higher score indicated better physical well-being related QoL. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure and 'n' signifies those participants who were evaluable for this measure at given time points for each group, respectively.
Time frame: Baseline, 3, 6, 9, 12, 18, 24, 30, 36, 48, 60 months after randomization
Change From Baseline in Social/Family Well-Being (SWB) Sub-scale Score at 3, 6, 9, 12, 18, 24, 30, 36, 48 and 60 Months: QoL Sub-study
The SWB subscale assessed social/family well-being related QoL in participants with breast cancer. SWB subscale comprised of 7 items (distant from friends, emotional support, support from friends, family acceptance, family communication, close to main support, sexual satisfaction). Participants indicated how true a statement had been for them using a 5-point scale from 0 (not at all) to 4 (very much). For items that were negatively framed, the scores were reversed for the analysis so that higher scores equated to a good QoL. Total SWB score was calculated as the sum of all the 7 items and ranged from 0 to 28, where higher score indicated better social/family well-being related QoL. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure and 'n' signifies those participants who were evaluable for this measure at given time points for each group, respectively.
Time frame: Baseline, 3, 6, 9, 12, 18, 24, 30, 36, 48, 60 months after randomization
Change From Baseline in Relationship With Doctor (RWD) Subscale Score at 3, 6, 9, 12, 18, 24, 30, 36, 48 and 60 Months: QoL Substudy
The RWD subscale assessed relationship with doctor in participants with breast cancer. RWD subscale comprised of 2 items (confidence in doctors, doctor answered questions). Participants indicated how true a statement had been for them using a 5-point scale from 0 (not at all) to 4 (very much). Total RWD score was calculated as the sum of the 2 items and ranged from 0 to 8, where higher score indicated better relationship with doctor. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure and 'n' signifies those participants who were evaluable for this measure at given time points for each group, respectively.
Time frame: Baseline, 3, 6, 9, 12, 18, 24, 30, 36, 48, 60 months after randomization
Change From Baseline in Emotional Well-Being (EWB) Subscale Score at 3, 6, 9, 12, 18, 24, 30, 36, 48 and 60 Months: QoL Sub-study
The EWB subscale assessed emotional well-being related QoL in participants with breast cancer. EWB subscale comprised of 6 items (felt sad, proud of coping, lost hope, felt nervous, worried about dying, worried about condition worsening). Participants indicated how true a statement had been for them using a 5-point scale from 0 (not at all) to 4 (very much). For items that were negatively framed, the scores were reversed for the analysis so that higher scores equate to a good QoL. Total EWB score was calculated as the sum of the 6 items and ranged from 0 to 24, where higher score indicated better emotional well-being related QoL. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure and 'n' signifies those participants who were evaluable for this measure at given time points for each group, respectively.
Time frame: Baseline, 3, 6, 9, 12, 18, 24, 30, 36, 48, 60 months after randomization
Change From Baseline in Functional Well-Being (FWB) Sub-scale Score at 3, 6, 9, 12, 18, 24, 30, 36, 48 and 60 Months: QoL Sub-study
The FWB subscale assessed functional well-being related QoL in participants with breast cancer. FWB subscale comprised of 7 items (able to work, work fulfilled, able to enjoy life, acceptance of illness, sleeping well, enjoyed normal fun activities, contented with QoL). Participants indicated how true a statement had been for them using a 5-point scale from 0 (not at all) to 4 (very much). Total FWB score was calculated as the sum of the 7 items and ranged from 0 to 28, where higher score indicated better functional well-being related QoL. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure and 'n' signifies those participants who were evaluable for this measure at given time points for each group, respectively.
Time frame: Baseline, 3, 6, 9, 12, 18, 24, 30, 36, 48, 60 months after randomization
Change From Baseline in Breast Cancer Subscale (BCS) Score at 3, 6, 9, 12, 18, 24, 30, 36, 48 and 60 Months: QoL Sub-study
The BCS subscale assessed health related QoL in participants with breast cancer. BCS subscale comprised of 9 items (short of breath, self-conscious dress, tender/swollen arms, sexually attractive, bothered by hair loss, worried about familial risk, worried about family stress, bothered by weight change, able to feel like a woman). Participants indicated how true a statement had been for them using a 5-point scale from 0 (not at all) to 4 (very much). For items that were negatively framed, the scores were reversed for the analysis so that higher scores equated to a good QoL. Total BCS score was calculated as the sum of the 9 items and ranged from 0 to 36, where higher score indicated better QoL. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure and 'n' signifies those participants who were evaluable for this measure at given time points for each group, respectively.
Time frame: Baseline, 3, 6, 9, 12, 18, 24, 30, 36, 48, 60 months after randomization
Number of Participants With Severe Endocrine Symptoms: QoL Sub-study
Participants indicated prevalence of an endocrine subscale items using a 5-point scale, where 0 (not at all), 1 (a little bit), 2 (somewhat), 3 (quite a bit), 4 (very much). Endocrine items were grouped in five categories vasomotor (hot flushes, cold sweats, night sweats, sleeping difficulties), neuropsychological (lack of energy, nervous feeling, lightheaded/dizzy, headaches, mood swings, feeling irritable), gastrointestinal symptoms (nausea, gained weight, vomiting, diarrhea, bloated feeling), gynecological symptoms (vaginal discharge, vaginal irritation, vaginal bleeding, vaginal dryness, discomfort with intercourse, lost interest in sex, breast tenderness) and other symptoms (pain, feeling ill, side effects). Number of participants who reported severe endocrine symptoms (defined as response categories "quite a bit" and "very much") were presented.
Time frame: Baseline up to 24 months after randomization
Percentage of Participants With Endometrial Thickness Greater Than or Equal to (>=) 5 Millimeter (mm): Endometrial Sub-study
Endometrial thickness was assessed using transvaginal ultrasound examination. 'n' signifies those participants who were evaluable for this measure at given time points for each group, respectively.
Time frame: 6, 12, 24, 36 months after randomization, 6, 12, 24 months post-treatment
Endometrial Thickness: Endometrial Sub-study
Endometrial thickness was assessed using transvaginal ultrasound examination. 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome and 'n' signifies those participants who were evaluable for this measure at given time points for each group, respectively.
Time frame: Baseline, 6, 12, 24, 36 months after randomization, 6, 12, 24 months post-treatment
Uterine and Overall Ovary Volume: Endometrial Sub-study
Uterine volume (UV) and ovarian volume was estimated using ultrasonography. Uterine volume = (longitudinal diameter \* transverse diameter \* anteroposterior diameter of uterus)/(2\*1000). Ovary volume = \[(longitudinal diameter \* transverse diameter \* anteroposterior diameter of ovary) \* 3.14\]/(6\*1000). Overall ovary volume (OV) is calculated as the sum of the right and left ovary volume. 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome and 'n' signifies those participants who were evaluable for this measure at given time points for each group, respectively.
Time frame: 6, 12, 24, 36 months after randomization, 6, 12, 24 months post-treatment
Number of Participants With Polyps, Fibroids and Ovarian Cysts: Endometrial Sub-study
Number of participants with presence of polyps (POL) and fibroids (FIB) at post-baseline time points compared to the baseline (BL) status of 'yes', 'no' or 'missing' (that is, participants reporting POL/FIB at post-baseline time points who had yes, no or missing POL/FIB status at baseline, respectively) were presented. Result for number of participants with ovarian cysts was not analyzed at post-baseline time points as very few participants reported ovarian cysts at baseline.
Time frame: 6, 12, 24, 36 months after randomization, 6, 12, 24 months post-treatment
Percentage of Participants With at Least 1 Gynecological Symptoms: Endometrial Sub-study
Gynecological symptoms included bleeding/spotting, pelvic pain, leucorrhoea and vaginal itching.
Time frame: Baseline up to 24 months post-treatment
Number of Participants With Histological Findings: Endometrial Sub-study
Time frame: Baseline up to 24 months post-treatment
The publication describing study results (Coombes RC et al; N Engl J Med 350; 1119) stated that 4742 participants were enrolled in study. It was later discovered that 2 participants were randomized twice. Hence, 4740 participants were enrolled in this study.
| Milestone | Exemestane | Tamoxifen |
|---|---|---|
| Started | 2352 | 2372 |
| Treated | 2321 | 2337 |
| Completed | 1810 | 1830 |
| Not completed | 542 | 542 |
| Withdrew: Adverse event | 170 | 145 |
| Withdrew: Withdrawal by subject | 150 | 107 |
| Withdrew: Protocol violation | 19 | 22 |
| Withdrew: Death | 22 | 16 |
| Withdrew: Lost to follow-up | 15 | 10 |
| Withdrew: Recurrence | 109 | 179 |
| Withdrew: Randomized, but not treated | 31 | 35 |
| Withdrew: Other | 26 | 28 |
DFS defined as time from randomization to earliest documentation of breast cancer relapse or death from any cause. DFS at Month 36 post-randomization was defined as probability of participants alive and disease-free at 36 months after the randomization. Participants withdrawn from the study for any reason in the absence of relapse were censored at the date they were last seen. Relapse was categorized as follows: loco-regional: ipsilateral breast or axillary nodal relapse; distant: distant relapse, including supraclavicular nodes; second primary breast cancer: contralateral breast cancer, excluding ductal carcinoma in situ.
| probability of DFS | Exemestane | Tamoxifen |
|---|---|---|
| Disease-Free Survival (DFS) at Month 36 Post-Randomization: Main Study | 0.90 (0.89 to 0.92) | 0.86 (0.85 to 0.88) |
OS was defined as the duration from randomization to death (due to any cause). OS at Month 36 post-randomization was defined as probability of participants' survival at 36 months after the randomization. For participants who were alive, OS was censored at the last available assessment. Probability of OS at Month 36 post-randomization was reported using Kaplan-Meier estimates at Month 36 post-randomization based on 120-month follow-up data.
| probability of OS | Exemestane | Tamoxifen |
|---|---|---|
| Overall Survival (OS) at Month 36 Post-Randomization: Main Study | 0.953 (0.945 to 0.962) | 0.941 (0.932 to 0.951) |
Number of events of second primary breast cancer in contralateral breast (excluding ductal carcinoma in situ) were reported.
| events | Exemestane | Tamoxifen |
|---|---|---|
| Number of Events of Second Breast Cancer in Contralateral Breast: Main Study | 57 | 75 |
BMD measurements for Lumbar spine (LS) and Proximal Femur (Total Hip \[TH\]) were performed using dual energy X-ray absorptiometry (DXA) for participants who entered the bone-metabolism sub-study. 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure and 'n' signifies those participants who were evaluable for this measure at given time points for each group, respectively.
| percent change | Exemestane | Tamoxifen |
|---|---|---|
| Change at 6 months on-treatment: LS (n=84,96) | -2.64 ± 2.89 | -0.22 ± 2.55 |
| Change at 6 months on-treatment: TH (n=82,96) | -1.31 ± 2.20 | -0.13 ± 1.90 |
| Change at 12 months on-treatment: LS (n=82,96) | -2.98 ± 3.30 | -0.19 ± 3.53 |
| Change at 12 months on-treatment: TH (n=82,95) | -2.17 ± 2.34 | -0.39 ± 2.17 |
| Change at 24 months on-treatment: LS (n=82,92) | -3.69 ± 4.12 | -0.47 ± 3.38 |
| Change at 24 months on-treatment: TH (n=79,93) | -2.81 ± 2.61 | -0.91 ± 2.66 |
| Change at 24 months post-treatment: LS (n=74,81) | -2.17 ± 5.09 | -3.44 ± 4.28 |
| Change at 24 months post-treatment: TH (n=73,84) | -3.06 ± 4.35 | -4.15 ± 4.01 |
BMD measurements for femoral neck (FN) and femoral wards (FW) were performed using dual energy X-ray absorptiometry (DXA) for participants who entered the bone-metabolism sub-study. 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure and 'n' signifies those participants who were evaluable for this measure at given time points for each group, respectively.
| percent change | Exemestane | Tamoxifen |
|---|---|---|
| Change at 6 months on-treatment: FN (n=82,94) | -1.91 ± 3.17 | -0.30 ± 3.75 |
| Change at 6 months on-treatment: FW (n=82,94) | -2.02 ± 4.57 | 0.32 ± 5.53 |
| Change at 12 months on-treatment: FN (n=82,95) | -2.56 ± 3.26 | -0.32 ± 3.60 |
| Change at 12 months on-treatment: FW (n=81,95) | -3.51 ± 4.88 | -1.30 ± 5.84 |
| Change at 24 months on-treatment: FN (n=78,89) | -4.00 ± 3.61 | -0.78 ± 4.85 |
| Change at 24 months on-treatment: FW (n=72,87) | -4.75 ± 6.29 | -1.86 ± 7.32 |
| Change at 24 months post-treatment: FN (n=61,69) | -4.10 ± 5.57 | -4.95 ± 6.46 |
| Change at 24 months post-treatment: FW (n=60,68) | -6.07 ± 7.63 | -8.60 ± 8.15 |
BMD measurements for Lumbar spine (LS) and Proximal Femur (Total Hip \[TH\]) were performed using dual energy X-ray absorptiometry (DXA) for participants who entered the bone-metabolism sub-study. Results were scored as T-score. T-score indicated how many standard deviations higher or lower participant's value was when compared to the young normal reference mean. Using the World Health Organization (WHO) criteria for osteoporosis, a T-score of greater than or equal to (\>=)-1.0 was classified as normal, a T-score of greater than -2.5 to less than -1.0 as osteopenic, and a T-score less than or equal to (\<=)-2.5 as osteoporotic. Here 'n' signifies those participants who were evaluable for this measure at given time points for each group, respectively.
| T-score | Exemestane | Tamoxifen |
|---|---|---|
| Baseline: LS (n=86,99) | -0.62 ± 1.12 | -0.45 ± 1.14 |
| Baseline: TH (n=86,99) | -0.27 ± 0.97 | -0.12 ± 1.01 |
| Change at 6 months on-treatment: LS (n=84,96) | -0.24 ± 0.26 | -0.02 ± 0.23 |
| Change at 6 months on-treatment: TH (n=82,96) | -0.10 ± 0.19 | -0.00 ± 0.16 |
| Change at 12 months on-treatment: LS (n=82,96) | -0.26 ± 0.30 | -0.02 ± 0.32 |
| Change at 12 months on-treatment: TH (n=82,95) | -0.16 ± 0.21 | -0.03 ± 0.18 |
| Change at 24 months on-treatment: LS (n=82,92) | -0.32 ± 0.41 | -0.04 ± 0.31 |
| Change at 24 months on-treatment: TH (n=79,93) | -0.21 ± 0.27 | -0.07 ± 0.24 |
| Change at 24 months post-treatment: LS (n=74,81) | -0.21 ± 0.47 | -0.33 ± 0.41 |
| Change at 24 months post-treatment: TH (n=73,84) | -0.25 ± 0.38 | -0.34 ± 0.33 |
Bone specific alkaline phosphatase (BAP) serum concentration analyzed using enzyme immuno assay (EIA) at post-baseline time points was expressed as percentage of baseline BAP serum concentration. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure and 'n' signifies those participants who were evaluable for this measure at given time points for each group, respectively.
| percentage of baseline concentration | Exemestane | Tamoxifen |
|---|---|---|
| 3 months: on-treatment (n=81, 92) | 113.47 (108.74 to 118.41) | 104.35 (100.03 to 108.85) |
| 6 months: on-treatment (n=83, 95) | 121.01 (107.99 to 135.60) | 104.34 (99.18 to 109.76) |
| 9 months: on-treatment (n=79, 92) | 139.62 (131.65 to 148.06) | 98.17 (92.95 to 103.67) |
| 12 months: on-treatment (n=82, 96) | 148.96 (139.83 to 158.68) | 100.47 (94.36 to 106.97) |
| 18 months: on-treatment (n=80, 95) | 158.33 (147.97 to 169.41) | 102.72 (96.18 to 109.69) |
| 24 months: on-treatment (n=81, 90) | 155.89 (145.04 to 167.56) | 105.12 (98.36 to 112.35) |
| 30 months: on-treatment (n=50, 65) | 144.89 (125.83 to 166.83) | 108.33 (99.51 to 117.94) |
| 36 months: end of treatment (n=19, 31) | 150.82 (127.82 to 177.97) | 113.87 (101.28 to 128.03) |
| 12 months: post-treatment (n=67, 87) | 140.19 (129.98 to 151.19) | 149.69 (138.34 to 161.97) |
| 24 months: post-treatment (n=62, 77) | 128.73 (114.70 to 144.48) | 142.20 (129.09 to 156.64) |
C-terminal telopeptide (CTX) serum concentration analyzed using competitive enzyme-linked immunosorbent assay (ELISA) at post-baseline time points was expressed as percentage of baseline CTX serum concentration. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure and 'n' signifies those participants who were evaluable for this measure at given time points for each group, respectively.
| percentage of baseline concentration | Exemestane | Tamoxifen |
|---|---|---|
| 3 months: on-treatment (n=81, 93) | 144.14 (127.25 to 163.27) | 99.19 (89.37 to 110.09) |
| 6 months: on-treatment (n=83, 95) | 197.47 (176.51 to 220.92) | 93.67 (84.75 to 103.51) |
| 9 months: on-treatment (n=79, 92) | 226.04 (202.51 to 252.30) | 94.40 (85.44 to 104.29) |
| 12 months: on-treatment (n=81, 96) | 232.69 (206.42 to 262.31) | 94.59 (86.27 to 103.71) |
| 18 months: on-treatment (n=80, 95) | 199.68 (171.75 to 232.15) | 90.35 (81.82 to 99.76) |
| 24 months: on-treatment (n=81, 90) | 177.80 (154.58 to 204.50) | 88.80 (78.96 to 99.87) |
| 30 months: on-treatment (n=50, 65) | 179.29 (150.83 to 213.11) | 91.62 (80.20 to 104.66) |
| 36 months: end of treatment (n=19, 31) | 130.00 (94.91 to 178.06) | 99.34 (81.16 to 121.58) |
| 12 months: post-treatment (n=67, 87) | 110.87 (94.93 to 129.49) | 136.50 (121.05 to 153.91) |
| 24 months: post-treatment (n=62, 77) | 100.34 (84.62 to 118.98) | 124.03 (109.98 to 139.88) |
Osteocalcin (OC) serum concentration analyzed using ELISA and procollagen T1 c-peptide (PICP) serum concentration analyzed using sandwich EIA at post-baseline time points was expressed as percentage of baseline OC serum concentration and baseline PICP serum concentration, respectively. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure and 'n' signifies those participants who were evaluable for this measure at given time points, for each group respectively.
| percentage of baseline concentration | Exemestane | Tamoxifen |
|---|---|---|
| 3 months, on-treatment: OC (n=81, 92) | 149.49 (137.88 to 162.09) | 101.02 (94.14 to 108.40) |
| 3 months, on-treatment: PICP (n=81, 92) | 117.23 (109.63 to 125.35) | 102.19 (97.34 to 107.27) |
| 6 months, on-treatment: OC (n=83, 95) | 193.44 (177.49 to 210.81) | 97.69 (91.78 to 103.98) |
| 6 months, on-treatment: PICP (n=83, 95) | 133.50 (125.30 to 142.23) | 99.78 (95.18 to 104.61) |
| 9 months, on-treatment: OC (n=79, 93) | 230.41 (209.80 to 253.05) | 92.52 (86.02 to 99.50) |
| 9 months, on-treatment: PICP (n=79, 92) | 131.73 (124.27 to 139.63) | 96.52 (91.21 to 102.14) |
| 12 months, on-treatment: OC (n=82, 96) | 227.59 (208.40 to 248.56) | 95.75 (88.46 to 103.65) |
| 12 months, on-treatment: PICP (n=82, 96) | 128.68 (122.22 to 135.50) | 100.18 (95.23 to 105.39) |
| 18 months, on-treatment: OC (n=80, 95) | 230.72 (207.16 to 256.95) | 93.98 (87.54 to 100.90) |
| 18 months, on-treatment: PICP (n=80, 95) | 125.40 (116.86 to 134.56) | 103.25 (97.38 to 109.47) |
| 24 months, on-treatment: OC (n=81, 90) | 190.18 (171.07 to 211.41) | 89.29 (82.19 to 97.00) |
| 24 months: on-treatment: PICP (n=81, 90) | 123.75 (115.11 to 133.05) | 103.94 (97.75 to 110.52) |
| 30 months, on-treatment: OC (n=50, 65) | 187.23 (165.02 to 212.43) | 87.34 (79.64 to 95.79) |
| 30 months, on-treatment: PICP (n=50, 65) | 113.76 (102.05 to 126.82) | 103.36 (94.57 to 112.97) |
| 36 months, end of treatment: OC (n=19, 30) | 167.03 (121.37 to 229.86) | 90.77 (76.63 to 107.52) |
| 36 months, end of treatment: PICP (n=19, 31) | 95.33 (79.82 to 113.84) | 87.22 (76.34 to 99.66) |
| 12 months, post-treatment: OC (n=67, 87) | 143.85 (125.83 to 164.44) | 152.32 (135.49 to 171.24) |
| 12 months, post-treatment: PICP (n=67, 87) | 91.53 (84.27 to 99.42) | 108.67 (100.59 to 117.39) |
| 24 months, post-treatment: OC (n=62, 77) | 130.78 (114.03 to 150.00) | 146.36 (128.87 to 166.22) |
| 24 months, post-treatment: PICP (n=62, 77) | 90.46 (81.68 to 100.19) | 100.74 (92.95 to 109.19) |
Deoxy-pyridinoline (DPD) urine concentration (adjusted for urinary creatinine) analyzed using competitive EIA at post-baseline time points was expressed as percentage of baseline DPD urine concentration. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure and 'n' signifies those participants who were evaluable for this measure at given time points for each group, respectively.
| percentage of baseline concentration | Exemestane | Tamoxifen |
|---|---|---|
| 3 months: on-treatment (n=82, 91) | 130.49 (121.56 to 140.07) | 106.99 (99.66 to 114.85) |
| 6 months: on-treatment (n=83, 95) | 145.13 (133.61 to 157.64) | 103.42 (96.64 to 110.68) |
| 9 months: on-treatment (n=80, 92) | 160.12 (147.40 to 173.93) | 101.08 (94.85 to 107.72) |
| 12 months: on-treatment (n=82, 97) | 155.53 (143.40 to 168.70) | 104.51 (98.23 to 111.19) |
| 18 months: on-treatment (n=77, 96) | 139.57 (129.65 to 150.25) | 99.25 (93.11 to 105.78) |
| 24 months: on-treatment (n=78, 90) | 135.30 (125.10 to 146.33) | 99.11 (92.56 to 106.12) |
| 30 months: on-treatment (n=49, 63) | 121.39 (108.66 to 135.62) | 95.97 (87.65 to 105.07) |
| 36 months: end of treatment (n=19, 31) | 107.64 (89.11 to 130.02) | 101.04 (86.77 to 117.65) |
| 12 months: post-treatment (n=65, 84) | 117.94 (107.07 to 129.92) | 128.47 (118.34 to 139.46) |
| 24 months: post-treatment (n=61, 77) | 105.50 (96.08 to 115.84) | 120.84 (112.37 to 129.96) |
N-telopeptide of Type 1 collagen (NTX) urine concentration (adjusted for urinary creatinine) analyzed using competitive inhibition EIA at post-baseline time points was expressed as percentage of baseline NTX urine concentration. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure and 'n' signifies those participants who were evaluable for this measure at given time points for each group, respectively.
| percentage of baseline concentration | Exemestane | Tamoxifen |
|---|---|---|
| 3 months: on-treatment (n=82, 91) | 128.35 (118.11 to 139.48) | 101.92 (94.39 to 110.05) |
| 6 months: on-treatment (n=83, 95) | 153.67 (141.89 to 166.44) | 100.64 (92.92 to 109.00) |
| 9 months: on-treatment (n=80, 92) | 168.15 (152.93 to 184.90) | 101.44 (92.13 to 111.68) |
| 12 months: on-treatment (n=82, 97) | 177.58 (160.20 to 196.85) | 104.42 (96.57 to 112.91) |
| 18 months: on-treatment (n=77, 96) | 171.46 (153.32 to 191.75) | 98.74 (89.88 to 108.46) |
| 24 months: on-treatment (n=78, 90) | 167.87 (148.36 to 189.95) | 104.55 (93.40 to 117.03) |
| 30 months: on-treatment (n=49, 63) | 168.52 (144.54 to 196.48) | 96.51 (83.74 to 111.22) |
| 36 months: end of treatment (n=19, 31) | 152.13 (112.43 to 205.87) | 105.58 (84.56 to 131.83) |
| 12 months: post-treatment (n=65, 84) | 121.00 (101.05 to 144.88) | 158.12 (139.47 to 179.26) |
| 24 months: post-treatment (n=61, 77) | 108.18 (108.18 to 129.77) | 143.98 (124.26 to 166.83) |
| participants | Exemestane | Tamoxifen |
|---|---|---|
| Number of Participants With Fracture: Bone Metabolism Sub-study | 7 | 10 |
The TOI was defined as the sum of 23 items based on following Functional Assessment of Cancer Therapy - Breast version \[FACT-B\] subscales: Physical well-being (7 items), Functional well-being (7 items), Breast cancer subscale (9 items). Each item was scaled from 0='Not at all' to 4='Very much'. Total TOI score ranged from 0 to 92, where higher TOI score indicated better health-related quality of life (QoL). A change of five points in the TOI scores was considered clinically meaningful. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure and 'n' signifies those participants who were evaluable for this measure at given time points for each group, respectively. Results for 30, 36, 48, 60 months were not reported because data for these time points was only summarized as graphical presentation.
| units on a scale | Exemestane | Tamoxifen |
|---|---|---|
| Change at 3 months (n=251, 251) | -0.61 ± 7.72 | -0.16 ± 7.24 |
| Change at 6 months (n=244, 243) | -2.10 ± 9.66 | -0.01 ± 7.96 |
| Change at 9 months (n=242, 235) | -1.18 ± 8.62 | 0.17 ± 8.10 |
| Change at 12 months (n=230, 238) | -0.40 ± 8.03 | -0.66 ± 8.49 |
| Change at 18 months (n=232, 227) | -0.95 ± 8.99 | -0.11 ± 8.32 |
| Change at 24 months (n=221, 213) | -0.57 ± 9.06 | 0.54 ± 8.36 |
The FACT-ES assessed health-related QoL in participants with breast cancer. ES subscale comprised of 18 items (hot flushes,cold sweats,night sweats, vaginal discharge,vaginal irritation,vaginal bleeding,vaginal dryness,discomfort with intercourse,lost interest in sex,gained weight,light headed/dizzy,vomiting,had diarrhea,headaches,felt bloated,breast tenderness,mood swings, felt irritable).Participants indicated how true a statement was for them using a 5-point scale from 0 (not at all) to 4 (very much). For items that were negatively framed, the scores were reversed for the analysis so that higher scores equated to a good QoL. Total FACT-ES score was calculated as sum of all the 18 items and ranged from 0 to 72, where higher score indicated better QoL. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure and 'n' signifies those participants who were evaluable for this measure at given time points for each group, respectively.
| units on a scale | Exemestane | Tamoxifen |
|---|---|---|
| Change at 3 months (n=254, 253) | 0.04 ± 6.67 | 0.70 ± 6.40 |
| Change at 6 months (n=245, 243) | 0.17 ± 7.26 | 0.96 ± 6.54 |
| Change at 9 months (n=243, 238) | 1.10 ± 6.54 | 1.32 ± 6.29 |
| Change at 12 months (n=233, 236) | 1.98 ± 6.72 | 1.15 ± 7.08 |
| Change at 18 months (n=235, 226) | 1.25 ± 7.52 | 1.41 ± 6.67 |
| Change at 24 months (n=222, 214) | 1.93 ± 7.26 | 1.51 ± 6.87 |
FACT-GBE assessed health-related quality of life (QoL) in participants with breast cancer. It consisted of 56 items,summarized to 7 subscales(subscale 1 to 6 constituted total FACT-B and subscale 7 constituted total ES):physical well-being(7 items), social/family well-being(7 items),relationship with doctor (2 items),emotional well-being(6 items),functional well-being(7 items),breast cancer subscale(9 items),endocrine symptoms(18 items). Participants indicated how true a statement had been for them using 5-point scale from 0(not at all) to 4(very much). For items that were negatively framed,scores were reversed for analysis so that higher scores equated to good QoL. Total FACT-GBE score=sum of all 56 items(range 0 to 224, where higher score indicated better QoL. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure and 'n' signifies those participants who were evaluable for this measure at given time points for each group, respectively.
| units on a scale | Exemestane | Tamoxifen |
|---|---|---|
| Change at 3 months (n=252, 252) | -0.91 ± 17.41 | -0.38 ± 16.17 |
| Change at 6 months (n=244, 243) | -3.12 ± 17.84 | -0.04 ± 16.21 |
| Change at 9 months (n=243, 236) | -1.28 ± 15.09 | -0.38 ± 17.99 |
| Change at 12 months (n=229, 236) | 0.38 ± 18.91 | -0.53 ± 14.71 |
| Change at 18 months (n=232, 225) | -0.67 ± 17.37 | 0.06 ± 16.26 |
| Change at 24 months (n=220, 212) | -1.48 ± 22.44 | 1.43 ± 16.32 |
The PWB subscale assessed physical well-being related QoL in participants with breast cancer. PWB subscale comprised of 7 items (energy lack, nausea, family needs, pain, side effects, felt ill, forced to stay in bed). Participants indicated how true a statement had been for them using a 5-point scale from 0 (not at all) to 4 (very much). For items that were negatively framed, the scores were reversed for the analysis so that higher scores equated to a good QoL. Total PWB score was calculated as the sum of all the 7 items and ranged from 0 to 28, where higher score indicated better physical well-being related QoL. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure and 'n' signifies those participants who were evaluable for this measure at given time points for each group, respectively.
| units on a scale | Exemestane | Tamoxifen |
|---|---|---|
| Change at 3 months (n=253, 252) | -0.32 ± 3.05 | -0.02 ± 2.98 |
| Change at 6 months(n=246, 244) | -1.08 ± 4.16 | 0.13 ± 2.88 |
| Change at 9 months (n=242, 237) | -0.37 ± 3.16 | 0.06 ± 3.16 |
| Change at 12 months (n=233, 238) | -0.26 ± 2.90 | -0.12 ± 3.30 |
| Change at 18 months(n=234, 228) | -0.19 ± 3.09 | 0.02 ± 2.81 |
| Change at 24 months (n=223, 214) | -0.005 ± 0.208 | 0.22 ± 0.214 |
The SWB subscale assessed social/family well-being related QoL in participants with breast cancer. SWB subscale comprised of 7 items (distant from friends, emotional support, support from friends, family acceptance, family communication, close to main support, sexual satisfaction). Participants indicated how true a statement had been for them using a 5-point scale from 0 (not at all) to 4 (very much). For items that were negatively framed, the scores were reversed for the analysis so that higher scores equated to a good QoL. Total SWB score was calculated as the sum of all the 7 items and ranged from 0 to 28, where higher score indicated better social/family well-being related QoL. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure and 'n' signifies those participants who were evaluable for this measure at given time points for each group, respectively.
| units on a scale | Exemestane | Tamoxifen |
|---|---|---|
| Change at 3 months (n=252, 249) | -0.25 ± 3.90 | -0.37 ± 3.59 |
| Change at 6 months (n=245, 241) | -0.43 ± 3.84 | -0.47 ± 4.01 |
| Change at 9 months (n=242, 235) | -0.58 ± 3.61 | -0.53 ± 4.22 |
| Change at 12 months (n=231, 235) | 0.05 ± 4.03 | -0.56 ± 3.87 |
| Change at 18 months(n=234, 226) | -0.5 ± 3.62 | -0.69 ± 4.31 |
| Change at 24 months (n=219, 212) | -0.99 ± 4.96 | -0.72 ± 4.44 |
The RWD subscale assessed relationship with doctor in participants with breast cancer. RWD subscale comprised of 2 items (confidence in doctors, doctor answered questions). Participants indicated how true a statement had been for them using a 5-point scale from 0 (not at all) to 4 (very much). Total RWD score was calculated as the sum of the 2 items and ranged from 0 to 8, where higher score indicated better relationship with doctor. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure and 'n' signifies those participants who were evaluable for this measure at given time points for each group, respectively.
| units on a scale | Exemestane | Tamoxifen |
|---|---|---|
| Change at 3 months (n=254, 250) | 0.07 ± 1.20 | 0.08 ± 0.94 |
| Change at 6 months (n=244, 240) | -0.02 ± 1.34 | -0.04 ± 1.14 |
| Change at 9 months (n=243, 235) | -0.06 ± 1.12 | -0.07 ± 1.06 |
| Change at 12 months (n=233, 233) | -0.01 ± 1.20 | -0.07 ± 1.12 |
| Change at 18 months (n=233, 222) | -0.03 ± 1.27 | -0.21 ± 1.20 |
| Change at 24 months (n=221, 213) | -0.005 ± 1.25 | -0.12 ± 1.14 |
The EWB subscale assessed emotional well-being related QoL in participants with breast cancer. EWB subscale comprised of 6 items (felt sad, proud of coping, lost hope, felt nervous, worried about dying, worried about condition worsening). Participants indicated how true a statement had been for them using a 5-point scale from 0 (not at all) to 4 (very much). For items that were negatively framed, the scores were reversed for the analysis so that higher scores equate to a good QoL. Total EWB score was calculated as the sum of the 6 items and ranged from 0 to 24, where higher score indicated better emotional well-being related QoL. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure and 'n' signifies those participants who were evaluable for this measure at given time points for each group, respectively.
| units on a scale | Exemestane | Tamoxifen |
|---|---|---|
| Change at 3 months (n=255, 252) | 0.06 ± 2.84 | -0.01 ± 2.77 |
| Change at 6 months (n=246, 243) | -0.32 ± 2.88 | -0.1 ± 3.10 |
| Change at 9 months (n=243, 236) | -0.47 ± 3.05 | -0.27 ± 3.12 |
| Change at 12 months (n=232, 235) | -0.03 ± 2.55 | -0.33 ± 2.86 |
| Change at 18 months (n=235, 226) | -0.3 ± 3.05 | -0.04 ± 3.26 |
| Change at 24 months (n=222, 214) | -0.18 ± 3.05 | 0.07 ± 3.09 |
The FWB subscale assessed functional well-being related QoL in participants with breast cancer. FWB subscale comprised of 7 items (able to work, work fulfilled, able to enjoy life, acceptance of illness, sleeping well, enjoyed normal fun activities, contented with QoL). Participants indicated how true a statement had been for them using a 5-point scale from 0 (not at all) to 4 (very much). Total FWB score was calculated as the sum of the 7 items and ranged from 0 to 28, where higher score indicated better functional well-being related QoL. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure and 'n' signifies those participants who were evaluable for this measure at given time points for each group, respectively.
| units on a scale | Exemestane | Tamoxifen |
|---|---|---|
| Change at 3 months (n=254, 253) | -0.32 ± 3.79 | -0.18 ± 3.32 |
| Change at 6 months (n=246, 244) | -0.77 ± 4.31 | -0.43 ± 4.01 |
| Change at 9 months (n=243, 238) | -1.03 ± 3.96 | -0.38 ± 3.62 |
| Change at 12 months (n=232, 238) | -0.68 ± 4.07 | -0.91 ± 4.38 |
| Change at 18 months (n=232, 227) | -0.83 ± 4.14 | -0.8 ± 3.89 |
| Change at 24 months (n=222, 214) | -0.91 ± 4.49 | -0.45 ± 3.72 |
The BCS subscale assessed health related QoL in participants with breast cancer. BCS subscale comprised of 9 items (short of breath, self-conscious dress, tender/swollen arms, sexually attractive, bothered by hair loss, worried about familial risk, worried about family stress, bothered by weight change, able to feel like a woman). Participants indicated how true a statement had been for them using a 5-point scale from 0 (not at all) to 4 (very much). For items that were negatively framed, the scores were reversed for the analysis so that higher scores equated to a good QoL. Total BCS score was calculated as the sum of the 9 items and ranged from 0 to 36, where higher score indicated better QoL. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure and 'n' signifies those participants who were evaluable for this measure at given time points for each group, respectively.
| units on a scale | Exemestane | Tamoxifen |
|---|---|---|
| Change at 3 months (n=255, 252) | 0.05 ± 3.76 | -0.003 ± 3.96 |
| Change at 6 months (n=246, 244) | -0.33 ± 4.17 | 0.17 ± 4.31 |
| Change at 9 months (n=243, 239) | 0.3 ± 3.99 | 0.48 ± 4.22 |
| Change at 12 months (n=233, 238) | 0.61 ± 4.08 | 0.38 ± 4.12 |
| Change at 18 months (n=233, 227) | 0.06 ± 4.61 | 0.67 ± 4.35 |
| Change at 24 months (n=222, 214) | 0.36 ± 4.33 | 0.72 ± 4.35 |
Participants indicated prevalence of an endocrine subscale items using a 5-point scale, where 0 (not at all), 1 (a little bit), 2 (somewhat), 3 (quite a bit), 4 (very much). Endocrine items were grouped in five categories vasomotor (hot flushes, cold sweats, night sweats, sleeping difficulties), neuropsychological (lack of energy, nervous feeling, lightheaded/dizzy, headaches, mood swings, feeling irritable), gastrointestinal symptoms (nausea, gained weight, vomiting, diarrhea, bloated feeling), gynecological symptoms (vaginal discharge, vaginal irritation, vaginal bleeding, vaginal dryness, discomfort with intercourse, lost interest in sex, breast tenderness) and other symptoms (pain, feeling ill, side effects). Number of participants who reported severe endocrine symptoms (defined as response categories "quite a bit" and "very much") were presented.
| participants | Exemestane | Tamoxifen |
|---|---|---|
| Hot flushes | 151 | 146 |
| Cold sweats | 60 | 52 |
| Night sweats | 115 | 117 |
| Sleeping difficulties | 110 | 110 |
| Lack of energy | 115 | 108 |
| Nervous feeling | 68 | 65 |
| Lightheaded/dizzy | 34 | 37 |
| Headaches | 56 | 49 |
| Mood swings | 70 | 66 |
| Feeling irritable | 53 | 48 |
| Nausea | 16 | 14 |
| Gained weight | 150 | 152 |
| Vomiting | 6 | 6 |
| Diarrhea | 20 | 21 |
| Bloated feeling | 75 | 88 |
| Vaginal discharge | 36 | 55 |
| Vaginal irritation | 37 | 45 |
| Vaginal bleeding | 10 | 11 |
| Vaginal dryness | 78 | 88 |
| Discomfort with intercourse | 47 | 45 |
| Lost interest in sex | 128 | 142 |
| Breast tenderness | 66 | 76 |
| Pain | 66 | 60 |
| Feeling ill | 24 | 24 |
| Side effects | 54 | 57 |
Endometrial thickness was assessed using transvaginal ultrasound examination. 'n' signifies those participants who were evaluable for this measure at given time points for each group, respectively.
| percentage of participants | Exemestane | Tamoxifen |
|---|---|---|
| 6 months (n=58, 49) | 46.6 | 69.4 |
| 12 months (n=60, 52) | 30.0 | 55.8 |
| 24 months (n=61, 52) | 36.1 | 63.5 |
| 36 months (n=32, 17) | 21.9 | 76.5 |
| 6 months post-treatment (n=16, 17) | 31.3 | 70.6 |
| 12 months post-treatment (n=50, 37) | 30.0 | 32.4 |
| 24 months post-treatment (n=41, 31) | 34.1 | 29.0 |
Endometrial thickness was assessed using transvaginal ultrasound examination. 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome and 'n' signifies those participants who were evaluable for this measure at given time points for each group, respectively.
| mm | Exemestane | Tamoxifen |
|---|---|---|
| Baseline (n=60, 52) | 6.0 (1.0 to 29.0) | 6.0 (1.0 to 29.0) |
| 6 months (n=58, 49) | 4.0 (1.0 to 16.0) | 5.9 (2.0 to 23.0) |
| 12 months (n=59, 52) | 3.3 (1.0 to 20.4) | 5.5 (2.0 to 39.0) |
| 24 months (n=60, 52) | 4.0 (1.0 to 19.0) | 5.0 (1.0 to 26.0) |
| 36 months (n=31, 17) | 3.0 (1.0 to 12.0) | 7.0 (2.0 to 24.0) |
| 6 months post-treatment (n=16, 17) | 3.0 (1.0 to 16.6) | 5.8 (4.0 to 17.0) |
| 12 months post-treatment (n=49, 37) | 3.0 (1.0 to 17.0) | 4.0 (1.0 to 16.0) |
| 24 months post-treatment (n=40, 31) | 3.0 (1.0 to 21.0) | 3.8 (1.0 to 10.0) |
Uterine volume (UV) and ovarian volume was estimated using ultrasonography. Uterine volume = (longitudinal diameter \* transverse diameter \* anteroposterior diameter of uterus)/(2\*1000). Ovary volume = \[(longitudinal diameter \* transverse diameter \* anteroposterior diameter of ovary) \* 3.14\]/(6\*1000). Overall ovary volume (OV) is calculated as the sum of the right and left ovary volume. 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome and 'n' signifies those participants who were evaluable for this measure at given time points for each group, respectively.
| cubic centimeter (cm^3) | Exemestane | Tamoxifen |
|---|---|---|
| UV: 6 months (n=57, 47) | 25.2 (5.6 to 180.0) | 36.5 (4.1 to 149.8) |
| OV: 6 months (n=8, 6) | 1.8 (1.2 to 9.7) | 1.2 (0.6 to 4.2) |
| UV: 12 months (n=56, 49) | 23.3 (0.0 to 58.3) | 39.2 (6.7 to 214.2) |
| OV: 12 months (n=6, 5) | 2.3 (1.1 to 6.6) | 2.2 (0.7 to 3.8) |
| UV: 24 months (n=54, 51) | 26.3 (6.3 to 73.9) | 40.3 (4.3 to 148.9) |
| OV: 24 months (n=5, 6) | 2.0 (0.6 to 4.2) | 2.7 (1.4 to 12.4) |
| UV: 36 months (n=30, 18) | 21.5 (4.6 to 116.5) | 36.8 (6.8 to 143.3) |
| OV: 36 months (n=3, 2) | 1.5 (0.6 to 2.3) | 2.5 (1.8 to 3.2) |
| UV: 6 months post-treatment (n=14, 16) | 25.6 (10.5 to 82.9) | 31.6 (12.9 to 149.5) |
| OV: 6 months post-treatment (n=2, 4) | 10.1 (1.4 to 18.7) | 4.7 (2.8 to 11.4) |
| UV: 12 months post-treatment (n=42, 35) | 21.7 (8.8 to 96.1) | 30.0 (6.6 to 91.1) |
| OV: 12 months post-treatment (n=5, 4) | 2.8 (1.4 to 3.9) | 2.9 (2.1 to 5.3) |
| UV: 24 months post-treatment (n=38, 28) | 22.6 (4.8 to 47.2) | 27.8 (7.5 to 71.1) |
| OV: 24 months post-treatment (n=4, 4) | 1.6 (1.0 to 3.3) | 3.4 (2.1 to 4.2) |
Number of participants with presence of polyps (POL) and fibroids (FIB) at post-baseline time points compared to the baseline (BL) status of 'yes', 'no' or 'missing' (that is, participants reporting POL/FIB at post-baseline time points who had yes, no or missing POL/FIB status at baseline, respectively) were presented. Result for number of participants with ovarian cysts was not analyzed at post-baseline time points as very few participants reported ovarian cysts at baseline.
| participants | Exemestane | Tamoxifen |
|---|---|---|
| FIB: 6 months, BL Yes (n=60,50) | 4 | 6 |
| FIB: 6 months, BL No (n=60,50) | 2 | 1 |
| FIB: 6 months, BL Missing (n=60,50) | 2 | 0 |
| POL: 6 months, BL Yes (n=60,50) | 0 | 0 |
| POL: 6 months, BL No (n=60,50) | 2 | 0 |
| POL: 6 months, BL Missing (n=60,50) | 1 | 0 |
| FIB: 12 months, BL Yes (n=61,52) | 3 | 7 |
| FIB: 12 months, BL No (n=61,52) | 2 | 1 |
| FIB: 12 months, BL Missing (n=61,52) | 4 | 1 |
| POL: 12 months, BL Yes (n=61,52) | 0 | 0 |
| POL: 12 months, BL No (n=61,52) | 0 | 0 |
| POL: 12 months, BL Missing (n=61,52) | 1 | 0 |
| FIB: 24 months, BL Yes (n=61,52) | 3 | 5 |
| FIB: 24 months, BL No (n=61,52) | 3 | 0 |
| FIB: 24 months, BL Missing (n=61,52) | 0 | 2 |
| POL: 24 months, BL Yes (n=61,52) | 1 | 0 |
| POL: 24 months, BL No (n=61,52) | 0 | 1 |
| POL: 24 months, BL Missing (n=61,52) | 0 | 0 |
| FIB: 36 months, BL Yes (n=33,18) | 2 | 1 |
| FIB: 36 months, BL No (n=33,18) | 3 | 0 |
| FIB: 36 months, BL Missing (n=33,18) | 0 | 0 |
| POL: 36 months, BL Yes (n=33,18) | 0 | 0 |
| POL: 36 months, BL No (n=33,18) | 1 | 0 |
| POL: 36 months, BL Missing (n=33,18) | 0 | 0 |
| FIB: 6 months post-treatment, BL Yes (n=16,17) | 1 | 0 |
| FIB: 6 months post-treatment, BL No (n=16,17) | 1 | 0 |
| FIB: 6 months post-treatment,BL Missing(n=16,17) | 0 | 2 |
| POL: 6 months post-treatment, BL Yes (n=16,17) | 0 | 0 |
| POL: 6 months post-treatment, BL No (n=16,17) | 0 | 0 |
| POL: 6 months post-treatment,BL Missing(n=16,17) | 1 | 0 |
| FIB: 12 months post-treatment, BL Yes (n=51,38) | 1 | 1 |
| FIB: 12 months post-treatment, BL No (n=51,38) | 2 | 0 |
| FIB: 12 months post-treatment, BL Missing(n=51,38) | 1 | 1 |
| POL: 12 months post-treatment, BL Yes (n=51,38) | 0 | 0 |
| POL: 12 months post-treatment, BL No (n=51,38) | 0 | 0 |
| POL: 12 months post-treatment, BL Missing (n=51,38 | 0 | 2 |
| FIB: 24 months post-treatment, BL Yes (n=43,31) | 2 | 2 |
| FIB: 24 months post-treatment, BL No (n=43,31) | 2 | 1 |
| FIB: 24 months post-treatment, BL Missing(n=43,31) | 1 | 2 |
| POL: 24 months post-treatment, BL Yes (n=43,31) | 0 | 0 |
| POL: 24 months post-treatment, BL No (n=43,31) | 1 | 0 |
| POL: 24 months post-treatment, BL Missing(n=43,31) | 2 | 1 |
Gynecological symptoms included bleeding/spotting, pelvic pain, leucorrhoea and vaginal itching.
| percentage of participants | Exemestane | Tamoxifen |
|---|---|---|
| Percentage of Participants With at Least 1 Gynecological Symptoms: Endometrial Sub-study | 16.28 | 21.28 |
No measurements were reported for this outcome.
Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Exemestane | — | 383/2,320 (16.5%) | 1,905/2,249 (84.7%) |
| Tamoxifen | — | 439/2,338 (18.8%) | 1,888/2,279 (82.8%) |
| Event | Exemestane | Tamoxifen |
|---|---|---|
| Uterine polypReproductive system and breast disorders | 3/2320 | 25/2338 |
| Deep vein thrombosisVascular disorders | 4/2320 | 22/2338 |
| Condition aggravatedGeneral disorders | 17/2320 | 14/2338 |
| Second primary malignancyNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 8/2320 | 17/2338 |
| OsteoarthritisMusculoskeletal and connective tissue disorders | 8/2320 | 14/2338 |
| Abdominal painGastrointestinal disorders | 12/2320 | 6/2338 |
| Breast cancerNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 9/2320 | 12/2338 |
| Cerebrovascular accidentNervous system disorders | 10/2320 | 12/2338 |
| Vaginal haemorrhageReproductive system and breast disorders | 7/2320 | 11/2338 |
| PneumoniaInfections and infestations | 10/2320 | 4/2338 |
| Event | Exemestane | Tamoxifen |
|---|---|---|
| Hot flushes NOSVascular disorders | 491/2249 | 457/2279 |
| ArthralgiaMusculoskeletal and connective tissue disorders | 396/2249 | 246/2279 |
| FatigueGeneral disorders | 367/2249 | 344/2279 |
| HeadacheNervous system disorders | 305/2249 | 255/2279 |
| InsomniaPsychiatric disorders | 290/2249 | 205/2279 |
| Sweating increasedSkin and subcutaneous tissue disorders | 270/2249 | 242/2279 |
| DizzinessNervous system disorders | 224/2249 | 200/2279 |
| Hypertension NOSVascular disorders | 223/2249 | 191/2279 |
| Back painMusculoskeletal and connective tissue disorders | 208/2249 | 176/2279 |
| NauseaGastrointestinal disorders | 200/2249 | 208/2279 |
Intent-to-treat (ITT) population included all participants assigned to the treatment group to which they were randomized, irrespective of the treatment they actually received.
| Age, Continuous(years) | Exemestane | Tamoxifen | Total |
|---|---|---|---|
| Mean | 63.78 ± 8.12 | 63.69 ± 8.22 | 63.73 ± 8.17 |
| Sex: Female, Male(Participants) | Exemestane | Tamoxifen | Total |
|---|---|---|---|
| Female | 2352 | 2372 | 4724 |
| Male | 0 | 0 | 0 |
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The record gives a start of Feb 1998, a primary completion of Jun 2003 and a completion of Mar 2013. It does not say whether these dates are actual or estimated.
Results were first posted in Apr 2014, 10 years 10 months after primary completion.
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Studies of the drug tested here: Exemestane