NCT05563220: ELEVATE

Open-Label Umbrella Study To Evaluate Safety And Efficacy Of Elacestrant In Various Combination In Participants With Metastatic Breast Cancer

Recruiting now Phase 1, PHASE2 Last updated 6 January 2026

What this trial tests

Phase 1, PHASE2 trial testing Elacestrant in Breast Cancer in 435 participants. Currently enrolling.

Timeline

24 January 2023

Primary endpoint
27 December 2026

28 December 2028

Quick facts

Lead sponsor	Stemline Therapeutics, Inc.
Phase	Phase 1, PHASE2
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	435
Start date	24 January 2023
Primary completion	27 December 2026
Estimated completion	28 December 2028
Sites	118 locations across France, Italy, Belgium, United Kingdom, Germany, Hungary, Israel, Poland

Drugs / interventions tested

• Elacestrant (ELACESTRANT) — full drug profile →
• Alpelisib
• Everolimus (everolimus) — full drug profile →
• Ribociclib (ribociclib) — full drug profile →
• Palbociclib (Palbociclib) — full drug profile →
• Capivasertib
• Abemaciclib (abemaciclib) — full drug profile →

Conditions studied

• Breast Cancer — all drugs for Breast Cancer →
• Metastatic Breast Cancer — all drugs for Metastatic Breast Cancer →

Sponsor

Stemline Therapeutics, Inc. — full company profile →

Who can join

18 and older, any sex, with Breast Cancer or Metastatic Breast Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This is a multicenter, Phase 1b/2 trial in participants with estrogen receptor positive/human epidermal growth factor receptor 2 negative (ER+/HER2-) advanced/metastatic breast cancer. The phase 1b part of the trial will determine the recommended Phase 2 dose (RP2D) of elacestrant when administered in combination with alpelisib, everolimus, palbociclib, capivasertib, and ribociclib. The Phase 2 part of the trial will evaluate the efficacy and safety of the various combinations.

Publications & conference data

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

1. Triple Negative Breast Cancer Treatment Options and Limitations: Future Outlook.
   Obidiro O, Battogtokh G, Akala EO. · · 2023 · cited 326× · PMID 37513983 · DOI 10.3390/pharmaceutics15071796
2. Elacestrant: First Approval.
   Hoy SM. · · 2023 · cited 48× · PMID 37060385 · DOI 10.1007/s40265-023-01861-0
3. Therapies for the Treatment of Advanced/Metastatic Estrogen Receptor-Positive Breast Cancer: Current Situation and Future Directions.
   Rej RK, Roy J, Allu SR. · · 2024 · cited 32× · PMID 38339303 · DOI 10.3390/cancers16030552
4. Oral SERD, a Novel Endocrine Therapy for Estrogen Receptor-Positive Breast Cancer.
   Neupane N, Bawek S, Gurusinghe S, Ghaffary EM, et al · · 2024 · cited 26× · PMID 38339371 · DOI 10.3390/cancers16030619
5. Evaluating Elacestrant in the Management of ER-Positive, HER2-Negative Advanced Breast Cancer: Evidence to Date.
   Varella L, Cristofanilli M. · · 2023 · cited 17× · PMID 36993871 · DOI 10.2147/ott.s400563
6. Practical treatment strategies and novel therapies in the phosphoinositide 3-kinase (PI3K)/protein kinase B (AKT)/mammalian target of rapamycin (mTOR) pathway in hormone receptor-positive/human epidermal growth factor receptor 2 (HER2)-negative (HR+/HER2-) advanced breast cancer.
   Fanucci K, Giordano A, Erick T, Tolaney SM, et al · · 2024 · cited 10× · PMID 39674130 · DOI 10.1016/j.esmoop.2024.103997
7. Estrogen Receptor Alpha Mutations, Truncations, Heterodimers, and Therapies.
   Hancock GR, Gertz J, Jeselsohn R, Fanning SW. · · 2024 · cited 10× · PMID 38643482 · DOI 10.1210/endocr/bqae051
8. CDK4/6 as a Therapeutic Target in HR+/HER2- Breast Cancer Cells-Current Treatment Status.
   Krupa K, Liszcz-Tymoszuk A, Czerw N, Czerw A, et al · · 2025 · cited 9× · PMID 40149372 · DOI 10.3390/cancers17061039