Phase 3
N=235
Study in Post-menopausal Women With Hormone Receptor Positive, HER2-negative Advanced Breast Cancer
Post Menopausal Breast Cancer
Bottom Line
View on ClinicalTrials.gov: NCT03176238 ↗Enrolled (actual)
235
Serious AEs
31.9%
Results posted
Apr 2020
Primary outcome: Primary: Summary of Number of Participants With Treatment Emergent Adverse Events (TEAE) - All Grades — 4; 0; 4; 195 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- everolimus (Drug); exemestane (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Novartis Pharmaceuticals
- Primary completion
- Jan 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Summary of Number of Participants With Treatment Emergent Adverse Events (TEAE) - All Grades |
4; 0; 4; 195; 36; 231 | — |
| SECONDARY Percentage of Participants Response Rates (Best Overall and Overall) |
1.5; 0.00; 1.3; 20.1; 8.3; 18.3 | — |
| SECONDARY Percentage of Participants Clinical Benefit Rate |
48.2; 30.6; 45.5 | — |
| SECONDARY Progression Free Survival (PFS) |
40.6; 37.0; 40.6 | — |
| SECONDARY Percent of Participants Event-free Probability Estimates of Deterioration of Eastern Cooperative Oncology Group (ECOG) Performance Status |
100.0; 100.0; 100.00; 95.0; 79.8; 92.7 | — |
Summary
This international, multi-center, open-label, single-arm study evaluated the safety and tolerability profile of everolimus in post-menopausal women with HR positive, HER2 negative locally advanced or metastatic breast cancer after documented recurrence or progression following a non-steroidal aromatase inhibitors (NSAI) therapy in Novartis Oncology emergent growth market (EGM) countries.Data was presented by Asian countries vs Non-Asian countries to confirm no difference in safety and efficacy. Summary statistics were presented.
Eligibility Criteria
Inclusion Criteria
- Postmenopausal women with metastatic, recurrent or locally advanced breast cancer not amenable to curative treatment by surgery or radiotherapy.
- Histological or cytological confirmation of hormone-receptor positive (HR+) breast cancer.
- Disease refractory to non-steroidal aromatase inhibitors, defined as:
- Recurrence while on, or within 12 months (365 days) of completion of adjuvant therapy with letrozole or anastrozole, or
- Progression while on, or within one month (30 days) of completion of letrozole or anastrozole treatment for locally advanced or metastatic breast cancer (ABC).
- Radiological or objective evidence of recurrence or progression on or after the last systemic therapy prior to enrolment.
- Patients must have had:
- At least one lesion that could have been accurately measured in at least one dimension
- 20 mm with conventional imaging techniques or ≥ 10 mm with spiral CT or MRI, or
- Bone lesions: lytic or mixed (lytic + blastic) in the absence of measurable disease as defined above.
- Adequate bone marrow, coagulation, liver and renal function.
- ECOG performance status ≤ 2.
Exclusion Criteria
- Patients overexpressing HER2 by local laboratory testing (IHC 3+ staining or in situ hybridization positive). Patients with IHC 2+ must have a negative in situ hybridization test.
- Patients with only non-measurable lesions other than bone metastasis (e.g. pleural effusion, ascites).
- Patients with more than one prior chemotherapy line for ABC. A chemotherapy line is an anticancer regimen(s) that contained at least 1 cytotoxic chemotherapy agent, given for a minimum of 21 days.
- Previous treatment with mTOR inhibitors.
- Known hypersensitivity to mTOR inhibitors, e.g. Sirolimus (rapamycin).
- Patients with a known history of HIV seropositivity. Screening for HIV infection at baseline was not required.
- Patient who were being treated with drugs recognized as being strong inhibitors or inducers of the isoenzyme CYP3A
- History of brain or other CNS metastases, including leptomeningeal metastasis.
Data sourced from ClinicalTrials.gov (NCT03176238). 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.