Ignite Creation Date:
2024-05-06 @ 7:59 PM
Last Modification Date:
2024-10-26 @ 3:17 PM
Study NCT ID:
NCT06201234
Status:
RECRUITING
Last Update Posted:
2024-01-11
First Post:
2023-12-07
Brief Title:
Evaluating the Addition of Elacestrant Oral SERD to Olaparib PARP-inhibitor in Patients With AdvancedMetastatic HRHER2- Breast Cancer
Sponsor:
German Breast Group
Organization:
German Breast Group
Study Overview
Official Title:
Phase II Study Evaluating the Addition of Elacestrant an Oral Selective Estrogen Receptor Degrader SERD to Standard-of-care Olaparib in Patients With Hormone Receptor HR-Positive HER2-negative Locally Advanced or Metastatic Breast Cancer With gBRCA12 Mutations
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ELEMENT
Brief Summary:
Trial design
Phase II prospective multi-center randomized open label parallel group study in patients with HR-positive HER2-negative locally advanced or metastatic breast cancer with gBRCA12 mutation with 21 randomization into Arm A olaparib elacestrant or arm B olaparib Treatment in either arm will be given until disease progression unacceptable toxicity withdrawal of patients consent to study participation or end of study
Trial population
Patients with HR-positive HER2-negative locally advanced or metastatic breast cancer with gBRCA12 mutation with an indication for standard-of-care PARP inhibitor therapy and planned treatment with olaparib an ECOG performance status of 0-2 and life expectancy of 6 months with normal bone marrow and kidney functions and no active or newly diagnosed central nervous system CNS metastases or symptomatic metastatic visceral disease at risk of life-threatening complications
Interventions
Patients randomized to Arm A will receive 600 mg olaparib daily and 400 mg elacestrant daily while patients randomized to Arm B will receive 600 mg olaparib daily Blood tests hematology biochemistry will be performed at the beginning of every cycle and imaging for tumor assessment chest and abdominopelvic imaging as well as QoL assessments will be performed every three months and in case of suspicion of progressionend of study
Phase II prospective multi-center randomized open label parallel group study in patients with HR-positive HER2-negative locally advanced or metastatic breast cancer with gBRCA12 mutation with 21 randomization into Arm A olaparib elacestrant or arm B olaparib Treatment in either arm will be given until disease progression unacceptable toxicity withdrawal of patients consent to study participation or end of study
Trial population
Patients with HR-positive HER2-negative locally advanced or metastatic breast cancer with gBRCA12 mutation with an indication for standard-of-care PARP inhibitor therapy and planned treatment with olaparib an ECOG performance status of 0-2 and life expectancy of 6 months with normal bone marrow and kidney functions and no active or newly diagnosed central nervous system CNS metastases or symptomatic metastatic visceral disease at risk of life-threatening complications
Interventions
Patients randomized to Arm A will receive 600 mg olaparib daily and 400 mg elacestrant daily while patients randomized to Arm B will receive 600 mg olaparib daily Blood tests hematology biochemistry will be performed at the beginning of every cycle and imaging for tumor assessment chest and abdominopelvic imaging as well as QoL assessments will be performed every three months and in case of suspicion of progressionend of study
Detailed Description:
Patients with HR-positive HER2-negative advanced or metastatic breast cancer and gBRCA12 mutations have a low progression-free survival PFS and represent a patient population with a high unmet need hence further treatment options should be explored to improve patient outcomes
Elacestrant is a novel nonsteroidal orally bioavailable estrogen receptor antagonist SERD that has shown efficacy in heavily pretreated patients with HR-positive HER2-negative breast cancer and in those with ESR1 mutations known to confer endocrine resistance and has thus gained approval in 2023 by the Food and Drug Administration FDA and the European Medicines Agency EMA for postmenopausal women or adult men with ER-positive HER2-negative ESR1-mutated advanced or metastatic breast cancer with disease progression following at least one line of ET
Olaparib is approved by the EMA for deleterious or suspected deleterious gBRCA-mutated HER2-negative metastatic BC based on positive outcomes in the phase III OlympiAD trial which showed improved median PFS response rates and less toxicity with olaparib compared to SOC
The purpose of the proposed study is to investigate if the addition of elacestrant to standard olaparib therapy could potentially lead to an improvement in PFS compared to olaparib alone in patients with HR-positive HER2-negative locally advanced or metastatic breast cancer with gBRCA12 mutations
ELEMENT is a phase II prospective multi-center randomized open label parallel group study in patients with HR-positive HER2-negative locally advanced or metastatic breast cancer with gBRCA12 mutation with 21 randomization into Arm A olaparib elacestrant or arm B olaparib Treatment in either arm will be given until disease progression unacceptable toxicity withdrawal of patients consent to study participation or end of study
Elacestrant is a novel nonsteroidal orally bioavailable estrogen receptor antagonist SERD that has shown efficacy in heavily pretreated patients with HR-positive HER2-negative breast cancer and in those with ESR1 mutations known to confer endocrine resistance and has thus gained approval in 2023 by the Food and Drug Administration FDA and the European Medicines Agency EMA for postmenopausal women or adult men with ER-positive HER2-negative ESR1-mutated advanced or metastatic breast cancer with disease progression following at least one line of ET
Olaparib is approved by the EMA for deleterious or suspected deleterious gBRCA-mutated HER2-negative metastatic BC based on positive outcomes in the phase III OlympiAD trial which showed improved median PFS response rates and less toxicity with olaparib compared to SOC
The purpose of the proposed study is to investigate if the addition of elacestrant to standard olaparib therapy could potentially lead to an improvement in PFS compared to olaparib alone in patients with HR-positive HER2-negative locally advanced or metastatic breast cancer with gBRCA12 mutations
ELEMENT is a phase II prospective multi-center randomized open label parallel group study in patients with HR-positive HER2-negative locally advanced or metastatic breast cancer with gBRCA12 mutation with 21 randomization into Arm A olaparib elacestrant or arm B olaparib Treatment in either arm will be given until disease progression unacceptable toxicity withdrawal of patients consent to study participation or end of study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None