Record 1 of
1 records.
|
Regimen 1
Drug Therapy:
• Everolimus (Afinitor)
• Examestane (Aromasin) |
Regimen 2
Drug Therapy:
• Examestane (Aromasin) |
|
| Participating Institution |
Multicenter (n=189) |
| Cancer Indication |
breast cancer |
| Clinical
Indication |
breast cancer, postmenopausal,
Er+ and HEr2-, locally advanced or metastatic, hormone refractory |
| Clinical
Status |
Phase III (begin 6/09, closed
2/11) USA, Australia, Brazil, Canada, Egypt, Europe (Austria, Belgium,
Czech Republic, France, Germany Hungary, Italy, Netherlands, Norway,
Poland: Spain, UK), Hong Kong, Japan, New Zealand, South Korea,
Thailand, Turkey |
| Completion
Date |
December 2013 |
| Clinical
Trial Title |
Everolimus in Combination With
Exemestane in the Treatment of Postmenopausal Women With Estrogen
Receptor Positive Locally Advanced or Metastatic Breast Cancer
Refractory to Letrozole or Anastrozole |
| Trial
Acronym |
Breast cancer trials of OraL
EveROlimus-2 (BOLERO-2) |
| Clinical
Trial Objective |
The trial’s primary endpoint was
PFS based on local investigator radiology assessment. Other endpoints
include OS, ORR, safety, patient-reported outcome, CBR and changes in
markers of bone metabolism. |
| Protocol
ID |
CRAD001Y2301, EUDRACT Number:
2008-008698-69; NCT00863655 |
| Protocol
Link |
Link to Protocol |
| Protocol Description |
In this double
blind, placebo-controlled, phase III clinical trial trial patients were
randomized (2:1) to either PO everolimus (10 mg/day; n= 485), or
placebo plus PO exemestane (25 mg/day; n=239).
|
| Administration
Route |
PO |
| Target |
Mammalian target of rapamycin
(mTOR) |
| Enrollment |
724 patients (everolimus plus
exemestane=485; placebo plus exemestane=239). |
| Toxicity |
AE observed were
consistent with those previously reported with everolimus with the most
common Grade 3 or 4 AE being stomatitis (7.7%), anemia (5.8%), dyspnea
(3.9%), hyperglycemia (4.3%), fatigue (3.7%), non-infectious
pneumonitis (3.1%), and increase in liver enzymes (3.1%).
|
| Result
Summary |
According to
results reported in September 2011, at the European Multidisciplinary
Cancer Congress, treatment with Afinitor (everolimus) tablets plus
exemestane more than doubled PFS and reduced the risk of cancer
progression by 57% versus exemestane alone in patients with Er+HEr2-
advanced breast cancer that recurred or progressed while on or
following previous treatment with hormonal therapies, letrozole or
anastrozole. At a pre-planned analysis, the trial met its primary
endpoint of PFS showing treatment with everolimus resulted in a PFS to
6.9 months compared to 2.8 months (hazard ratio= 0.43; p<0.0001) by
local investigator assessment. This improvement was consistent across
all subgroups including number of prior therapies, presence of visceral
disease, bone metastases and prior use of chemotherapy. According to an
analysis by an independent central radiology review committee
everolimus extended PFS to 10.6 months compared to 4.1 months (HR=0.36;
p<0.0001). Other endpoints include OS, ORR, safety, patient-reported
outcome, CBR and changes in markers of bone metabolism. These data are
being evaluated and will be submitted for publication or presentation
in a peer-reviewed forum.
|
| Result
- PFS |
Everolimus=6.9 months versus
placebo=2.8 months (hazard ratio=0.43; p<0.0001) according to local
investigator analysis and 10.6 months compared to 4.1 months (HR=0.36;
p<0.0001), respectively, according to an analysis by an independent
central radiology review committee; improvement was consistent across
all subgroups including number of prior therapies, presence of visceral
disease, bone metastases and prior use of chemotherapy. |
| Reference |
Baselga J, etal,
European Multidisciplinary Cancer Congress 2011 (EMCC11), Abs. 9LBA
|
| Current
as of |
September 27, 2011 |
NEW MEDICINE, INC.
P.O. BOX 909, LAKE FOREST, CA 92609
PHONE: 1-949-830-0448 FAX: 1-949-830-0887
INFO@NEWMEDINC.COM
|
