Evaluating the Addition of Elacestrant (Oral SERD) to Olaparib (PARP-inhibitor) in Patients With Advanced/Metastatic HR+/HER2- Breast Cancer

Sponsor
GBG Forschungs GmbH
Study ID
NCT06201234
Phase
PHASE2
Status
Recruiting
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Conditions

  • Advanced or Metastatic Breast Cancer
  • BRCA1 Mutation
  • BRCA2 Mutation
  • Hormone Receptor Positive HER-2 Negative Breast Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

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.

Key Dates

Start date
Dec 13, 2024
Status verified
Nov 2025
Primary completion
Dec 31, 2028
Completion
Dec 31, 2028

Study Design

Enrollment
176 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm A: Olaparib + elacestrant*
    Treatment will be given until disease progression, unacceptable toxicity, withdrawal of patient´s consent to study participation, or end of study. \* Together with GnRH analogue in pre- and perimenopausal women, and in men, at least two weeks prior to treatment. * Elacestrant tablets 400 mg orally daily * Olaparib 600 mg orally daily The protocol provides procedures for specific adverse events requiring dose modifications or delays.
  • Active Comparator: Arm B: Olaparib
    Treatment will be given until disease progression, unacceptable toxicity, withdrawal of patient´s consent to study participation, or end of study. • Olaparib 600 mg orally once daily The protocol provides procedures for specific adverse events requiring dose modifications or delays.

Primary Outcome Measure

Progression free survival (PFS) [ Time Frame: PFS is defined as the time from randomization to first progression as assessed by the investigator, or death, whichever occurs first, assessed up to 48 months. ]

Central Contacts

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