Phase 3
Completed N=4,724
Randomized Trial Of Exemestane Versus Continued Tamoxifen In Postmenopausal Women With Early Breast Cancer
Source: ClinicalTrials.gov NCT00038467 ↗Enrolled (actual)
4,724
Serious AEs
17.7%
Results posted
Apr 2014
Primary outcomePrimary: Disease-Free Survival (DFS) at Month 36 Post-Randomization: Main Study — 0.90; 0.86 probability of DFS — p=0.00003
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Disease-Free Survival (DFS) at Month 36 Post-Randomization: Main Study |
0.90; 0.86 | 0.00003 sig |
| SECONDARY Overall Survival (OS) at Month 36 Post-Randomization: Main Study |
0.953; 0.941 | 0.15737 |
| SECONDARY Number of Events of Second Breast Cancer in Contralateral Breast: Main Study |
57; 75 | — |
| SECONDARY 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 |
-2.64; -0.22; -1.31; -0.13; -2.98; -0.19 | <0.0001 sig |
| SECONDARY 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 |
-1.91; -0.30; -2.02; 0.32; -2.56; -0.32 | — |
| SECONDARY 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 |
-0.62; -0.45; -0.27; -0.12; -0.24; -0.02 | — |
| SECONDARY Percentage of Bone Specific Alkaline Phosphatase (BAP) Serum Concentration Relative to Baseline: Bone Metabolism Sub-study |
113.47; 104.35; 121.01; 104.34; 139.62; 98.17 | — |
| SECONDARY Percentage of C-Terminal Telopeptide (CTX) Serum Concentration Relative to Baseline: Bone Metabolism Sub-study |
144.14; 99.19; 197.47; 93.67; 226.04; 94.40 | — |
| SECONDARY Percentage of Osteocalcin (OC) and Procollagen T1 C-Peptide (PICP) Serum Concentration Relative to Baseline: Bone Metabolism Sub-study |
149.49; 101.02; 117.23; 102.19; 193.44; 97.69 | — |
| SECONDARY Percentage of Deoxy-pyridinoline (DPD) Urine Concentration Relative to Baseline: Bone Metabolism Sub-study |
130.49; 106.99; 145.13; 103.42; 160.12; 101.08 | — |
| SECONDARY Percentage of N-telopeptide of Type 1 Collagen (NTX) Urine Concentration Relative to Baseline: Bone Metabolism Sub-study |
128.35; 101.92; 153.67; 100.64; 168.15; 101.44 | — |
| SECONDARY Number of Participants With Fracture: Bone Metabolism Sub-study |
7; 10 | — |
| SECONDARY Change From Baseline in Treatment Outcome Index (TOI) at 3, 6, 9, 12, 18, 24, 30, 36, 48 and 60 Months: QoL Sub-study |
-0.61; -0.16; -2.10; -0.01; -1.18; 0.17 | 0.500 |
| SECONDARY 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 |
0.04; 0.70; 0.17; 0.96; 1.10; 1.32 | 0.260 |
| SECONDARY 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 |
-0.91; -0.38; -3.12; -0.04; -1.28; -0.38 | 0.727 |
| SECONDARY 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 |
-0.32; -0.02; -1.08; 0.13; -0.37; 0.06 | 0.265 |
| SECONDARY 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 |
-0.25; -0.37; -0.43; -0.47; -0.58; -0.53 | 0.712 |
| SECONDARY 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 |
0.07; 0.08; -0.02; -0.04; -0.06; -0.07 | 0.892 |
| SECONDARY 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 |
0.06; -0.01; -0.32; -0.1; -0.47; -0.27 | 0.792 |
| SECONDARY 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 |
-0.32; -0.18; -0.77; -0.43; -1.03; -0.38 | 0.648 |
| SECONDARY 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 |
0.05; -0.003; -0.33; 0.17; 0.3; 0.48 | 0.876 |
| SECONDARY Number of Participants With Severe Endocrine Symptoms: QoL Sub-study |
151; 146; 60; 52; 115; 117 | — |
| SECONDARY Percentage of Participants With Endometrial Thickness Greater Than or Equal to (>=) 5 Millimeter (mm): Endometrial Sub-study |
46.6; 69.4; 30.0; 55.8; 36.1; 63.5 | 0.0174 sig |
| SECONDARY Endometrial Thickness: Endometrial Sub-study |
6.0; 6.0; 4.0; 5.9; 3.3; 5.5 | — |
| SECONDARY Uterine and Overall Ovary Volume: Endometrial Sub-study |
25.2; 36.5; 1.8; 1.2; 23.3; 39.2 | — |
| SECONDARY Number of Participants With Polyps, Fibroids and Ovarian Cysts: Endometrial Sub-study |
4; 6; 2; 1; 2; 0 | — |
| SECONDARY Percentage of Participants With at Least 1 Gynecological Symptoms: Endometrial Sub-study |
16.28; 21.28 | — |
| SECONDARY Number of Participants With Histological Findings: Endometrial Sub-study |
— | — |
Eligibility Criteria
Inclusion Criteria
- postmenopausal women with histologically or cytologically confirmed primary breast adenocarcinoma, receiving tamoxifen and have been treated with tamoxifen continuously for between 2 and 3 years and one month, and still free of disease
Exclusion Criteria
- unresectable breast cancer
- ER negative primary tumor
Data sourced from ClinicalTrials.gov (NCT00038467). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.