Phase 2
Completed N=309
A Phase II Study of Everolimus in Combination With Exemestane Versus Everolimus Alone Versus Capecitabine in Advance Breast Cancer.
Source: ClinicalTrials.gov NCT01783444 ↗Enrolled (actual)
309
Serious AEs
31.4%
Results posted
Feb 2021
Primary outcomePrimary: Progression Free Survival (PFS) - Everolimus Plus Exemestane Versus Everolimus Alone — 8.41; 6.77 Months
Summary
This was a three-arm, randomized, open label, multi-center phase II study investigating the combination of everolimus (10mg daily) with exemestane (25mg daily) versus everolimus (10mg daily) versus capecitabine (1250mg/m2 twice daily for 14 days, 3-week cycle) in patients with estrogen-receptor positive, HER2 negative, advanced breast cancer after recurrence or progression on letrozole or anastrozole.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Progression Free Survival (PFS) - Everolimus Plus Exemestane Versus Everolimus Alone |
8.41; 6.77 | — |
| SECONDARY Progression Free Survival (PFS) - Everolimus Plus Exemestane Versus Capecitabine Alone |
8.41; 9.59 | — |
| SECONDARY Overall Survival (OS) |
23.06; 29.27; 25.56 | — |
| SECONDARY Overall Response Rate (ORR) |
21; 12; 23 | — |
| SECONDARY Clinical Benefit Rate (CBR) |
59; 43; 53 | — |
| SECONDARY Time to Eastern Cooperative Oncology Group (ECOG) Performance Deterioration |
72.57; 126.57; 120.00 | — |
| SECONDARY Time to 10% Definitive Deterioration in the Global Health Status / Quality of Life |
30.86; 23.86; 61.29 | — |
| SECONDARY Mean Change in Treatment Satisfaction Questionnaire for Medication (TSQM) Between Week 3 and 12 |
-4.8; -9.1; -2.6; -2.2; 1.2; 1.2 | — |
Eligibility Criteria
Key Inclusion Criteria
- Women with locally advanced, recurrent, or metastatic breast cancer along with confirmation of estrogen-receptor positive (ER+). Measurable disease defined as at least one lesion ≥ 10 mm by CT or MRI that can be accurately measured in at least one dimension (CT scan slice thickness ≤ 5 mm) OR • Bone lesions: lytic or mixed (lytic + blastic) in the absence of measurable disease as defined above.
Key Exclusion Criteria
- Patients who received more than one chemotherapy line. Patients with only non-measurable lesions other than lytic or mixed (lytic and blastic) bone metastasis.Previous treatment with exemestane, mTOR inhibitors, PI3K inhibitors or AKT inhibitors.
Data sourced from ClinicalTrials.gov (NCT01783444). 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.