NCT06201234: ELEMENT

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

Recruiting now Phase 2 Last updated 1 December 2025

What this trial tests

Phase 2 trial testing Olaparib + Elacestrant in Hormone Receptor Positive HER-2 Negative Breast Cancer in 176 participants. Currently enrolling.

Timeline

13 December 2024

Primary endpoint
31 December 2028

31 December 2028

Quick facts

Lead sponsor	GBG Forschungs GmbH
Phase	Phase 2
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	176
Start date	13 December 2024
Primary completion	31 December 2028
Estimated completion	31 December 2028
Sites	36 locations across Germany

Drugs / interventions tested

• Olaparib + Elacestrant — full drug profile →
• Olaparib (olaparib) — full drug profile →

Conditions studied

• Hormone Receptor Positive HER-2 Negative Breast Cancer — all drugs for Hormone Receptor Positive HER-2 Negative Breast Cancer →
• Advanced or Metastatic Breast Cancer — all drugs for Advanced or Metastatic Breast Cancer →
• BRCA1 Mutation — all drugs for BRCA1 Mutation →
• BRCA2 Mutation — all drugs for BRCA2 Mutation →

Sponsor

GBG Forschungs GmbH — full company profile →

Who can join

18 and older, any sex, with Hormone Receptor Positive HER-2 Negative Breast Cancer or Advanced or Metastatic Breast Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. Therapeutic advances and application of PARP inhibitors in breast cancer.
   Zhou T, Zhang J. · · 2025 · cited 9× · PMID 40359851 · DOI 10.1016/j.tranon.2025.102410
2. Impact of germline BRCA1/2 status on outcomes for patients with HR+/HER2- metastatic breast cancer treated with CDK4/6 inhibitors: a systematic review and meta-analysis.
   Bottosso M, Zurlo C, Miglietta F, Cattelan AC, et al · · 2025 · cited 5× · PMID 40737893 · DOI 10.1016/j.breast.2025.104544
3. Delivering precision oncology in metastatic breast cancer: Clinical impact of comprehensive genomic profiling-The CATCH experience.
   Hlevnjak M, Heublein S, Thewes V, Wagener L, et al · · 2026 · cited 1× · PMID 41170836 · DOI 10.1002/ijc.70208