Everolimus and Letrozole or Hormonal Therapy to Treat Endometrial Cancer

Draft scope assessment: unclear. Attached because the study's own record describes recurrent disease. The study was not selected for this indication by its sponsor, and its eligibility has not been reconciled against this page in full. Found because this study's registry identifier is printed in an FDA approval notice, an FDA product label or an NCI summary held by this site. The citing document and the exact position of the identifier inside it are recorded. Being cited is not a statement that the study supports this treatment.

Read the full study record and all posted results →

Linked outcomes

Measures are not ranked. Open each original source section for treatment groups, denominators, units and results.

exploratory · NOT_POSTED

To determine if relevant biomarkers correlate with response to treatment in each of the two arms. Unstained sections of tumor tissue will be used for hormone receptor (estrogen receptor-alpha, estrogen receptor-beta, progesterone receptor-A, progesterone receptor B and the G protein-coupled estrogen receptor, GPR-30) immunohistochemistry.

Source null

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exploratory · NOT_POSTED

To determine if relevant biomarkers correlate with response to treatment in each of the two arms. Unstained sections of tumor tissue will be used for mTOR pathway (including phosphorylated S6 ribosomal protein, PTEN, total and phosphorylated AKT, total and phosphorylated mTOR, and phospho-ERK1/2) immunohistochemistry

Source null

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primary · POSTED

A confirmed complete or partial response as defined by RECIST 1.1 was considered a response. "Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR

Eligible and treated participants. One participant in arm II was not treated. Participant flow contains all eligible participants.

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secondary · POSTED

Progression-free Survival is defined as the duration alive from study entry until progression is documented, or death; whichever comes sooner. Progressive disease is defined as at least a 5 mm absolute increase and a 20% relative increase in the sum of measurable target lesions' longest dimensions relative to the smallest sum at baseline or on study or the appearance of new lesions or unequivocal progression of existing non-target lesions.

Eligible Patients

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secondary · POSTED

Maximum grade of physician assessed adverse events graded and categorized using Common Toxicity Criteria for Adverse Events (CTCAE) version 4

Eligible and Treated Patients

→

secondary · POSTED

Survival is defined as the duration alive from study entry until death.

Eligible patients

→

Reported safety

Serious events are not the same as severe events. Compare the original safety groups and their at-risk populations.

Open the study safety table →

Quality of life and patient-reported measures

No linked quality-of-life measure is recorded for this setting and study.

Full draft applicability and source-link record

trial

release id: clinical-indications-draft-1
disease state id: ds-endometrial-cancer-keytruda-qlex-1191efca
nct id: NCT02228681
trial label: Everolimus and Letrozole or Hormonal Therapy to Treat Endometrial Cancer
applicability: unclear
applicability note: Attached because the study's own record describes recurrent disease. The study was not selected for this indication by its sponsor, and its eligibility has not been reconciled against this page in full.
curation status: draft
reviewed by: Source null
reviewed at: Source null
created at: 2026-09-10T00:00:00Z
provenance class: regulator-cited
discovery note: Found because this study's registry identifier is printed in an FDA approval notice, an FDA product label or an NCI summary held by this site. The citing document and the exact position of the identifier inside it are recorded. Being cited is not a statement that the study supports this treatment.
outcome Count: 6
harms Count: 2
qol Count: 0

outcomes

release id
clinical-indications-draft-1
disease state id
ds-endometrial-cancer-keytruda-qlex-1191efca
nct id
NCT02228681
outcome key
om-0004
source section id
NCT02228681-om-0004
source outcome index
4
endpoint
Hormone Receptor Immunohistochemistry
endpoint definition
To determine if relevant biomarkers correlate with response to treatment in each of the two arms. Unstained sections of tumor tissue will be used for hormone receptor (estrogen receptor-alpha, estrogen receptor-beta, progesterone receptor-A, progesterone receptor B and the G protein-coupled estrogen receptor, GPR-30) immunohistochemistry.
time origin
At study entry
analysis role
exploratory
reporting status
NOT_POSTED
data cutoff
Source null
population note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-endometrial-cancer-keytruda-qlex-1191efca
nct id
NCT02228681
outcome key
om-0005
source section id
NCT02228681-om-0005
source outcome index
5
endpoint
mTOR Pathway Immunohistochemistry
endpoint definition
To determine if relevant biomarkers correlate with response to treatment in each of the two arms. Unstained sections of tumor tissue will be used for mTOR pathway (including phosphorylated S6 ribosomal protein, PTEN, total and phosphorylated AKT, total and phosphorylated mTOR, and phospho-ERK1/2) immunohistochemistry
time origin
At study entry
analysis role
exploratory
reporting status
NOT_POSTED
data cutoff
Source null
population note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-endometrial-cancer-keytruda-qlex-1191efca
nct id
NCT02228681
outcome key
om-0000
source section id
NCT02228681-om-0000
source outcome index
0
endpoint
Frequency of Response
endpoint definition
A confirmed complete or partial response as defined by RECIST 1.1 was considered a response. "Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR
time origin
From date of randomization until the date of first documented progression or date of death , up to 3 years.
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
Eligible and treated participants. One participant in arm II was not treated. Participant flow contains all eligible participants.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-endometrial-cancer-keytruda-qlex-1191efca
nct id
NCT02228681
outcome key
om-0001
source section id
NCT02228681-om-0001
source outcome index
1
endpoint
Median Progression-free Survival
endpoint definition
Progression-free Survival is defined as the duration alive from study entry until progression is documented, or death; whichever comes sooner. Progressive disease is defined as at least a 5 mm absolute increase and a 20% relative increase in the sum of measurable target lesions' longest dimensions relative to the smallest sum at baseline or on study or the appearance of new lesions or unequivocal progression of existing non-target lesions.
time origin
Tumor measurements were done at 8 and 16 weeks after initiating treatment and then every 12 weeks and compared with baseline measurements prior to treatment. Measurements are continued until disease progression is documented or death.
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
Eligible Patients
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-endometrial-cancer-keytruda-qlex-1191efca
nct id
NCT02228681
outcome key
om-0002
source section id
NCT02228681-om-0002
source outcome index
2
endpoint
Frequency and Severity of CTCAE (Common Toxicity Criteria for Adverse Events) Version 4
endpoint definition
Maximum grade of physician assessed adverse events graded and categorized using Common Toxicity Criteria for Adverse Events (CTCAE) version 4
time origin
Assessed throughout the treatment period and for 30 days after discontinuation of treatment. Treatment continues until progression of disease.
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
Eligible and Treated Patients
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-endometrial-cancer-keytruda-qlex-1191efca
nct id
NCT02228681
outcome key
om-0003
source section id
NCT02228681-om-0003
source outcome index
3
endpoint
Median Survival
endpoint definition
Survival is defined as the duration alive from study entry until death.
time origin
Following treatment discontinuation, patients are followed quarterly for 2 years, semi-annually for 3 more years, annually thereafter.
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
Eligible patients
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z

arms

release id
clinical-indications-draft-1
disease state id
ds-endometrial-cancer-keytruda-qlex-1191efca
nct id
NCT02228681
outcome key
om-0000
arm key
OG000
arm label
Everolimus and Letrozole
regimen
Everolimus 10 mg daily plus letrozole 2.5 mg PO daily in a 28 day cycle.
analyzed count
37
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02228681-om-0000#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-endometrial-cancer-keytruda-qlex-1191efca
nct id
NCT02228681
outcome key
om-0000
arm key
OG001
arm label
Tamoxifen and Medroxyprogesterone Acetate
regimen
Tamoxifen 20 mg PO bid days 1-28 plus medroxyprogesterone acetate 200 mg PO days 8-14 and 22-28 repeating in a 28 day cycle.
analyzed count
36
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02228681-om-0000#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-endometrial-cancer-keytruda-qlex-1191efca
nct id
NCT02228681
outcome key
om-0001
arm key
OG000
arm label
Everolimus and Letrozole
regimen
Everolimus 10 mg daily plus letrozole 2.5 mg PO daily in a 28 day cycle.
analyzed count
37
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02228681-om-0001#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-endometrial-cancer-keytruda-qlex-1191efca
nct id
NCT02228681
outcome key
om-0001
arm key
OG001
arm label
Tamoxifen and Medroxyprogesterone Acetate
regimen
Tamoxifen 20 mg PO bid days 1-28 plus medroxyprogesterone acetate 200 mg PO days 8-14 and 22-28 repeating in a 28 day cycle.
analyzed count
37
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02228681-om-0001#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-endometrial-cancer-keytruda-qlex-1191efca
nct id
NCT02228681
outcome key
om-0002
arm key
OG000
arm label
Everolimus and Letrozole
regimen
Everolimus 10 mg daily plus letrozole 2.5 mg PO daily in a 28 day cycle.
analyzed count
37
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02228681-om-0002#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-endometrial-cancer-keytruda-qlex-1191efca
nct id
NCT02228681
outcome key
om-0002
arm key
OG001
arm label
Tamoxifen and Medroxyprogesterone Acetate
regimen
Tamoxifen 20 mg PO bid days 1-28 plus medroxyprogesterone acetate 200 mg PO days 8-14 and 22-28 repeating in a 28 day cycle.
analyzed count
36
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02228681-om-0002#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-endometrial-cancer-keytruda-qlex-1191efca
nct id
NCT02228681
outcome key
om-0003
arm key
OG000
arm label
Everolimus and Letrozole
regimen
Everolimus 10 mg daily plus letrozole 2.5 mg PO daily in a 28 day cycle.
analyzed count
37
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02228681-om-0003#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-endometrial-cancer-keytruda-qlex-1191efca
nct id
NCT02228681
outcome key
om-0003
arm key
OG001
arm label
Tamoxifen and Medroxyprogesterone Acetate
regimen
Tamoxifen 20 mg PO bid days 1-28 plus medroxyprogesterone acetate 200 mg PO days 8-14 and 22-28 repeating in a 28 day cycle.
analyzed count
37
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02228681-om-0003#groups/OG001

harms

release id
clinical-indications-draft-1
disease state id
ds-endometrial-cancer-keytruda-qlex-1191efca
nct id
NCT02228681
harm key
EG000
source section id
NCT02228681-ae
event group key
EG000
event group label
Everolimus and Letrozole
serious affected
13
serious at risk
37
other affected
37
other at risk
37
frequency threshold
0
collection period
up to 30 days after the last cycle.
event definition
Collected on a 28 day cycle while treatment continues and then up to 30 days after the last cycle.
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-endometrial-cancer-keytruda-qlex-1191efca
nct id
NCT02228681
harm key
EG001
source section id
NCT02228681-ae
event group key
EG001
event group label
Tamoxifen and Medroxyprogesterone Acetate
serious affected
10
serious at risk
36
other affected
36
other at risk
36
frequency threshold
0
collection period
up to 30 days after the last cycle.
event definition
Collected on a 28 day cycle while treatment continues and then up to 30 days after the last cycle.
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z

quality of life

setting source links

Preserved source evidence · Not medical advice