Phase 2
N=72
Safety and Efficacy of RAD001 (Everolimus) in Combination With Letrozole in the Treatment of Postmenopausal Women With Locally Advanced or Metastatic Breast Cancer
Postmenopausal Women · Locally Advanced Metastatic Breast Cancer · Metastatic Breast Cancer
Bottom Line
View on ClinicalTrials.gov: NCT01231659 ↗Enrolled (actual)
72
Serious AEs
36.1%
Results posted
Mar 2021
Primary outcome: Primary: Percentage of Participants With Overall Response Rate (ORR) — 37.2 Percentage of Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Everolimus (Drug); Letrozole (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Novartis Pharmaceuticals
- Primary completion
- Nov 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Overall Response Rate (ORR) |
37.2 | — |
| SECONDARY Median Time to Progression-Free Survival (PFS) |
9.0 | — |
| SECONDARY Median Time to Overall Survival (OS) |
22.3 | — |
| SECONDARY Disease Control Rate (DCR) |
85.7 | — |
| SECONDARY Long-term Safety and Tolerability |
72; 39; 7 | — |
Summary
This was a multi-center, Israeli phase II open label study evaluating treatment with RAD001 (10 mg daily) combined with letrozole (2.5 mg daily) in postmenopausal women after recurrence or progression on Tamoxifen, Anastrozole or Examestane.
There were no treatments specifically approved after recurrence or progression on AIs. Available options, based on common clinical practice and several treatment guidelines (e.g. NCCN treatment guidelines 2008), included fulvestrant.
Combining RAD001 with letrazole was a rational approach to the treatment of advanced Brest Cancer, offering the potential for inhibition of tumor cell growth\ proliferation and anti angiogenesis while at the same time potentially preventing the development of letrazole resistance.
Eligibility Criteria
Inclusion Criteria
- Postmenopausal women with estrogen receptor positive locally advanced or metastatic breast cancer after documented recurrence or progression on Tamoxifen, Anastrozole or Examestane.
- Refractory disease to hormonal therapy is defined as:
- Recurrence while on, or within 12 month of end of, adjuvant treatment with Tamoxifen , Anastrozole, or Exemestane.
- Recurrence while on, or within 24 month of end of, adjuvant treatment with Letrozole.
- Progression while on Tamoxifen, Anastrozole or Exemestane treatment for locally advanced or metastatic breast cancer.
Exclusion Criteria
- Prior use of chemotherapy and letrozole for Advanced Breast Cancer and mTOR inhibitors as the last anticancer treatment prior to study entry.
- Patients must have radiological evidence of recurrence or progression on last therapy prior to study entry.
Data sourced from ClinicalTrials.gov (NCT01231659). 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.