Phase 2
Completed N=159
A Study of Everolimus Plus Exemestane in Chinese Postmenopausal Women With Estrogen Receptor Positive, Locally Advanced, Recurrent, or Metastatic Breast Cancer After Recurrence or Progression on Non-steroidal Aromatase Inhibitor
Source: ClinicalTrials.gov NCT03312738 ↗Enrolled (actual)
159
Serious AEs
17.6%
Results posted
Jan 2024
Primary outcomePrimary: Progression-free Survival (PFS) Based on Local Radiology Review of Tumor Assessment — 7.4; 2.0 Months
Summary
This study aimed at evaluating the safety and efficacy of everolimus plus exemestane in Chinese postmenopausal women with ER+ HER2- locally advanced, recurrent, or metastatic breast cancer after recurrence or progression on letrozole or anastrozole.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Progression-free Survival (PFS) Based on Local Radiology Review of Tumor Assessment |
7.4; 2.0 | — |
| SECONDARY Progression-free Survival (PFS) Based on Blinded Independent Review Committee (BIRC) Assessment |
7.4; 3.1 | — |
| SECONDARY Overall Survival (OS) |
26.1; 22.7 | — |
| SECONDARY Overall Response Rate (ORR) Based on Local Radiology Review of Tumor Assessment |
10.0; 2.5 | — |
| SECONDARY Overall Response Rate (ORR) Based on BIRC Assessment |
8.8; 2.5 | — |
| SECONDARY Clinical Benefit Rate (CBR) Based on Local Radiology Review of Tumor Assessment |
42.5; 16.5 | — |
| SECONDARY Clinical Benefit Rate (CBR) Based on BIRC Assessment |
31.3; 11.4 | — |
| SECONDARY Time to Response (TTR) Based on Local Radiology Review of Tumor Assessment |
84.5; 53.0 | — |
| SECONDARY Time to Response (TTR) Based on BIRC Assessment |
57.0; 81.5 | — |
| SECONDARY Duration of Response (DOR) Based on Local Radiology Review of Tumor Assessment |
243.5; 561.5 | — |
| SECONDARY Duration of Response (DOR) Based on BIRC Assessment |
148.0; 279.0 | — |
| SECONDARY Time to Definitive Deterioration of the Eastern Cooperative Oncology Group Performance Status (ECOG PS) by at Least One Category of the Score From Baseline |
NA; NA | — |
| SECONDARY Everolimus Predose Concentration (Cmin) |
16.5 | — |
| SECONDARY Everolimus Concentration at 2 Hours Post Dose (C2h) |
44.2 | — |
| SECONDARY Exemestane Predose Concentration (Cmin) |
737; 502 | — |
| SECONDARY Exemestane Concentration at 2 Hours Post Dose (C2h) |
20500; 14300 | — |
| SECONDARY Estradiol Levels After 4 Weeks of Study Treatment |
5.98; 5.38; 3.98; 3.77 | — |
Eligibility Criteria
Key Inclusion Criteria
- Chinese Postmenopausal women with ER+ HER2- locally advanced, recurrent, or metastatic breast cancer. Locally advanced breast cancer must not be amenable to curative treatment by surgery or radiotherapy.
- Histological or cytological confirmation of estrogen-receptor positive (ER+) breast cancer
- Postmenopausal women. Postmenopausal status was defined either by:
- Prior bilateral oophorectomy
- Or age ≥60
- Or age 7% despite adequate therapy.
Data sourced from ClinicalTrials.gov (NCT03312738). 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.