Clinical trial NCT06201234: Evaluating the Addition of Elacestrant (Oral SERD) to Olaparib (PARP-inhibitor) in Patients With Advanced/Metastatic HR+/HER2- Breast Cancer
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 gBRCA1/2 Mutations
Conditions: Hormone Receptor Positive HER-2 Negative Breast Cancer
Advanced or Metastatic Breast Cancer
BRCA1 Mutation
BRCA2 Mutation
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 gBRCA1/2 mutation, with 2:1 randomization into Arm A (olaparib + elacestrant) or arm B (olaparib). Treatment in either arm will be given until disease progression, unacceptable toxicity, withdrawal of patient´s consent to study participation, or end of study.
Trial population:
Patients with HR-positive, HER2-negative locally advanced or metastatic breast cancer with gBRCA1/2 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 progression/end of study.
Interventions:
description: Olaparib 600 mg orally daily and elacestrant 400 mg orally daily
name: Olaparib + Elacestrant
type: Drug
description: Olaparib 600 mg orally daily
name: Olaparib
type: Drug
Study arms:
design_group_description: Treatment will be given until disease progression, unacceptable toxicity, withdrawal of patient´s consent to study participation, or end of study.<br/>* Together with GnRH analogue in pre- and perimenopausal women, and in men, at least two weeks prior to treatment.<br/>* Elacestrant tablets 400 mg orally daily<br/>* Olaparib 600 mg orally daily The protocol provides procedures for specific adverse events requiring dose modifications or delays.
design_group_title: Arm A: Olaparib + elacestrant*
design_group_type: Experimental
design_group_description: Treatment will be given until disease progression, unacceptable toxicity, withdrawal of patient´s consent to study participation, or end of study.<br/>• Olaparib 600 mg orally once daily<br/>The protocol provides procedures for specific adverse events requiring dose modifications or delays.
design_group_title: Arm B: Olaparib
design_group_type: Active Comparator
Sponsor: GBG Forschungs GmbH
Collaborators: Stemline Therapeutics, Inc.
Drug name mappings:
name: 奥拉帕利
lang: CN
name: Olaparib
lang: EN
name: オラパリブ
lang: JP
name: 艾拉司群
lang: CN
name: Elacestrant hydrochloride
lang: EN