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Open-Label Umbrella Study To Evaluate Safety And Efficacy Of Elacestrant In Various Combination In Patients With Metastatic Breast Cancer
This is a multicenter, Phase 1b/2 trial. The phase 1b part of the trial aims to determine the RP2D of elacestrant when administered in combination with alpelisib, everolimus, palbociclib, abemaciclib, and ribociclib. The Phase 2 part of the trial will evaluate the efficacy and safety of the various combinations in patients with ER+/HER2- advanced/metastatic breast cancer.
Study details:
This is a multicenter, Phase 1b/2 trial. The Phase 1b aims at selecting the RP2D dose, defined as a dose that is associated with less than 33% of patients experiencing a DLT of elacestrant when administered in combination with alpelisib, everolimus, palbociclib, abemaciclib, and ribociclib, that is, ≤1 patient experiencing a DLT out of 6 DLT evaluable patients. For each combination, this phase will have between 1 and 3 cohorts of 6 DLT-evaluable patients each.
The total number of DLT-evaluable patients in all the combinations will vary between 24 and 72. The Phase 2 part of the trial will evaluate the efficacy and safety of the various combinations in patients with ER+/HER2- advanced/metastatic breast cancer. The treatment arms will be:.
* Arm A: 50 patients: elacestrant with alpelisib;. * Arm B: 50 patients: elacestrant with everolimus;. * Arm C: 60 patients (30 patients in each combination): elacestrant with either abemaciclib or ribociclib;.
* Arm D: 90 patients (30 patients in each combination): elacestrant with either palbociclib, abemaciclib, or ribociclib. * Arm E: 60 patients: elacestrant with capivasertib. Phase 1b will have a total of 90 patients, while Phase 2 will have 310 patients for all treatment arm combinations.
Eligibility criteria
Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.
Inclusion criteria
Exclusion criteria
Eligibility
Age eligible for study : 18 and older
Healthy volunteers accepted : No
Gender eligible for study: All
Things to know
Study dates
Study start: 2023-01-24
Primary completion: 2026-12-27
Study completion finish: 2028-12-28
Study type
TREATMENT
Phase
PHASE1
PHASE2
Trial ID
NCT05563220
Intervention or treatment
DRUG: Elacestrant
DRUG: Alpelisib
DRUG: Everolimus
DRUG: Ribociclib
DRUG: Palbociclib
DRUG: Capivasertib
DRUG: Abemaciclib
Conditions
- • Breast Cancer
- • Metastatic Breast Cancer
Find a site
Closest Location:
Macquarie University
Research sites nearby
Select from list below to view details:
Macquarie University
Sydney, Not Specified, Australia
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Participant Group/Arm | Intervention/Treatment |
---|---|
EXPERIMENTAL: Phase 1b Arm A: elacestrant with alpelisib
| DRUG: Elacestrant
|
EXPERIMENTAL: Phase 1b Arm B: elacestrant with everolimus
| DRUG: Elacestrant
|
EXPERIMENTAL: Phase 1b Arm C: elacestrant with abemaciclib or ribociclib:
| DRUG: Elacestrant
|
EXPERIMENTAL: Phase 1b Arm D: elacestrant with either palbociclib, abemaciclib, or ribociclib (no prior CDK4/6i)
| DRUG: Elacestrant
|
EXPERIMENTAL: Phase 1b Arm E:
| DRUG: Elacestrant
|
What is the study measuring?
Primary outcome
Primary Outcome Measure | Primary Outcome Description | Primary Outcome Time Frame |
---|---|---|
Number of DLTs observed during the first cycle | Number of dose-limiting toxicities during the first cycle | 28 days |
Estimation of PFS rate at 6 months | PFS rate for each of the combination arms in patients who received prior ET and CDK4/6i in the metastatic setting | 6 months |
Secondary outcome
Secondary Outcome Measure | Secondary Outcome Description | Secondary Outcome Time Frame |
---|---|---|
Standard PK parameters including AUC0-tau, Cmax, Tmax, and Ctrough | The plasma PK of elacestrant and each of the combination drugs | 36 months |
Overall Response Rate | Proportion of patients who achieve a best overall response (BOR) of confirmed partial response (PR) or complete response (CR) | 36 months |
Duration of Response | Time from the date of the first documented CR/PR until the first radiological documentation of disease progression or death | 36 months |
Clinical Benefit Rate | Proportion of patients who have the best overall response with a complete response, partial response or stable disease | 36 months |
Progression-free survival | Time from the date of the first dose to the date of the first radiological documentation of disease progression or death, whichever occurs first | 36 months |
Overall Survival | Time from the date of the first dose to the date of death from any cause | 36 months |
Frequently Asked Questions
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