TriangleNCT02283658 · STUDY IN CONTEXT
Everolimus and Letrozole in Treating Patients With Recurrent Hormone Receptor Positive Ovarian, Fallopian Tube, or Primary Peritoneal Cavity Cancer
Draft scope assessment: narrower. Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. The condition was transformed or resolved through the terminology hierarchy to reach this cancer type, so the link itself is a candidate a reviewer must confirm. Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.
Read the full study record and all posted results →
Linked outcomes
The percentage of PFS12 successes will be estimated by the number of successes divided by the total number of evaluable patients. Ninety-five percent confidence intervals for the true success proportion will be calculated according to the exact binomial method. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), Disease progression in evaluable patients will be defined as one or more of the following: * Any new disease and/or clear progression of evaluable disease; OR * 2 fold elevation in CA-125 from its lowest level (either initial level or nadir, whichever is lowest, since study enrollment) combined with CA-125 elevation confirmed by re-assay at any time.
CA-125 response: The key secondary endpoint of the study will be a CA-125 response, defined as a 50% or greater reduction in baseline CA-125. The null hypothesis will be set at CA-125 response rate of 8.3%, based on the response of single agent letrozole, as reported by Bowman et al (7). The treatment of letrozole and everolimus will be considered promising, based on CA-125, if the observed CA-125 response rate is 30% or more.
A confirmed tumor response is defined to be either a complete response or partial response noted as the objective status on 2 consecutive evaluations at least 4 weeks apart. A complete response (CR) in evaluable patients will be defined as: * Disappearance of any sign of (evaluable) disease, AND * Normalization of CA-125; if CA-125 normalizes, it should be confirmed at any time. A partial response (PR) in evaluable patients will be defined as: * Decrement in CA-125 by \>50%, and * Improvement in any additional evaluable disease (if present) as assessed by the enrolling physician.
The number of patients with adverse events.The maximum grade for each type of adverse event (AE) will be recorded for each patient, and frequency tables will be reviewed to determine AE patterns. These tables are reported in the adverse events section of this report.
OS will be estimated using the method of Kaplan-Meier.
PFS will be estimated using the method of Kaplan-Meier. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), Disease progression in evaluable patients will be defined as one or more of the following: Any new disease and/or clear progression of evaluable disease; OR 2 fold elevation in CA-125 from its lowest level (either initial level or nadir, whichever is lowest, since study enrollment) combined with CA-125 elevation confirmed by re-assay at any time.
Reported safety
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-malignant-fallopian-tube-neoplasm
- nct id
- NCT02283658
- trial label
- Everolimus and Letrozole in Treating Patients With Recurrent Hormone Receptor Positive Ovarian, Fallopian Tube, or Primary Peritoneal Cavity Cancer
- applicability
- narrower
- applicability note
- Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. The condition was transformed or resolved through the terminology hierarchy to reach this cancer type, so the link itself is a candidate a reviewer must confirm.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- provenance class
- registry-condition-search
- discovery note
- Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.
- outcome Count
- 6
- harms Count
- 1
- qol Count
- 0
- outcomes
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-fallopian-tube-neoplasm
- nct id
- NCT02283658
- outcome key
- om-0000
- source section id
- NCT02283658-om-0000
- source outcome index
- 0
- endpoint
- Percentage of Patients Alive and Progression Free Survival at 12 Weeks
- endpoint definition
- The percentage of PFS12 successes will be estimated by the number of successes divided by the total number of evaluable patients. Ninety-five percent confidence intervals for the true success proportion will be calculated according to the exact binomial method. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), Disease progression in evaluable patients will be defined as one or more of the following: * Any new disease and/or clear progression of evaluable disease; OR * 2 fold elevation in CA-125 from its lowest level (either initial level or nadir, whichever is lowest, since study enrollment) combined with CA-125 elevation confirmed by re-assay at any time.
- time origin
- 12 weeks
- analysis role
- primary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- All evaluable 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-malignant-fallopian-tube-neoplasm
- nct id
- NCT02283658
- outcome key
- om-0001
- source section id
- NCT02283658-om-0001
- source outcome index
- 1
- endpoint
- Percentage of Participants With CA-125 Response
- endpoint definition
- CA-125 response: The key secondary endpoint of the study will be a CA-125 response, defined as a 50% or greater reduction in baseline CA-125. The null hypothesis will be set at CA-125 response rate of 8.3%, based on the response of single agent letrozole, as reported by Bowman et al (7). The treatment of letrozole and everolimus will be considered promising, based on CA-125, if the observed CA-125 response rate is 30% or more.
- time origin
- Up to 2 years
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- All evaluable 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-malignant-fallopian-tube-neoplasm
- nct id
- NCT02283658
- outcome key
- om-0002
- source section id
- NCT02283658-om-0002
- source outcome index
- 2
- endpoint
- Confirmed Response Rate, Estimated Using RECIST 1.1 Criteria
- endpoint definition
- A confirmed tumor response is defined to be either a complete response or partial response noted as the objective status on 2 consecutive evaluations at least 4 weeks apart. A complete response (CR) in evaluable patients will be defined as: * Disappearance of any sign of (evaluable) disease, AND * Normalization of CA-125; if CA-125 normalizes, it should be confirmed at any time. A partial response (PR) in evaluable patients will be defined as: * Decrement in CA-125 by \>50%, and * Improvement in any additional evaluable disease (if present) as assessed by the enrolling physician.
- time origin
- Up to 24 weeks
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- All evaluable 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-malignant-fallopian-tube-neoplasm
- nct id
- NCT02283658
- outcome key
- om-0003
- source section id
- NCT02283658-om-0003
- source outcome index
- 3
- endpoint
- Number of Participants Experiencing Adverse Events
- endpoint definition
- The number of patients with adverse events.The maximum grade for each type of adverse event (AE) will be recorded for each patient, and frequency tables will be reviewed to determine AE patterns. These tables are reported in the adverse events section of this report.
- time origin
- Up to 30 days post-treatment
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- All evaluable 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-malignant-fallopian-tube-neoplasm
- nct id
- NCT02283658
- outcome key
- om-0004
- source section id
- NCT02283658-om-0004
- source outcome index
- 4
- endpoint
- Overall Suravival(OS)
- endpoint definition
- OS will be estimated using the method of Kaplan-Meier.
- time origin
- Time from registration to death from any cause, assessed up to 2 years
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- All evaluable 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-malignant-fallopian-tube-neoplasm
- nct id
- NCT02283658
- outcome key
- om-0005
- source section id
- NCT02283658-om-0005
- source outcome index
- 5
- endpoint
- Progression Free Survival (PFS)
- endpoint definition
- PFS will be estimated using the method of Kaplan-Meier. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), Disease progression in evaluable patients will be defined as one or more of the following: Any new disease and/or clear progression of evaluable disease; OR 2 fold elevation in CA-125 from its lowest level (either initial level or nadir, whichever is lowest, since study enrollment) combined with CA-125 elevation confirmed by re-assay at any time.
- time origin
- Time from registration to the first of either disease progression or death from any cause, assessed up to 2 years
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- All evaluable 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-malignant-fallopian-tube-neoplasm
- nct id
- NCT02283658
- outcome key
- om-0000
- arm key
- OG000
- arm label
- Treatment (Everolimus and Letrozole)
- regimen
- Patients receive everolimus PO QD and letrozole PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
- analyzed count
- 19
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02283658-om-0000#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-fallopian-tube-neoplasm
- nct id
- NCT02283658
- outcome key
- om-0001
- arm key
- OG000
- arm label
- Treatment (Everolimus and Letrozole)
- regimen
- Patients receive everolimus PO QD and letrozole PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
- analyzed count
- 19
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02283658-om-0001#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-fallopian-tube-neoplasm
- nct id
- NCT02283658
- outcome key
- om-0002
- arm key
- OG000
- arm label
- Treatment (Everolimus and Letrozole)
- regimen
- Patients receive everolimus PO QD and letrozole PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
- analyzed count
- 19
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02283658-om-0002#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-fallopian-tube-neoplasm
- nct id
- NCT02283658
- outcome key
- om-0003
- arm key
- OG000
- arm label
- Treatment (Everolimus and Letrozole)
- regimen
- Patients receive everolimus PO QD and letrozole PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
- analyzed count
- 19
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02283658-om-0003#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-fallopian-tube-neoplasm
- nct id
- NCT02283658
- outcome key
- om-0004
- arm key
- OG000
- arm label
- Treatment (Everolimus and Letrozole)
- regimen
- Patients receive everolimus PO QD and letrozole PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
- analyzed count
- 19
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02283658-om-0004#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-fallopian-tube-neoplasm
- nct id
- NCT02283658
- outcome key
- om-0005
- arm key
- OG000
- arm label
- Treatment (Everolimus and Letrozole)
- regimen
- Patients receive everolimus PO QD and letrozole PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
- analyzed count
- 19
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02283658-om-0005#groups/OG000
- harms
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-fallopian-tube-neoplasm
- nct id
- NCT02283658
- harm key
- EG000
- source section id
- NCT02283658-ae
- event group key
- EG000
- event group label
- Treatment (Everolimus and Letrozole)
- serious affected
- 10
- serious at risk
- 19
- other affected
- 19
- other at risk
- 19
- frequency threshold
- 0
- collection period
- 2 years
- event definition
- The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting. All appropriate treatment areas should have access to a copy of the CTCAE version 4.0.
- 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