NCT04797728 (ELIPSE) is a EARLY_PHASE1 clinical trial of Elacestrant in Breast Cancer, sponsored by SOLTI Breast Cancer Research Group.

Who is sponsoring NCT04797728?

NCT04797728 is sponsored by SOLTI Breast Cancer Research Group.

What drugs are being tested in NCT04797728?

Interventions in NCT04797728: Elacestrant.

What condition does NCT04797728 study?

NCT04797728 studies Breast Cancer, Hormone Receptor Positive Breast Carcinoma.

Is NCT04797728 still recruiting?

NCT04797728 is currently completed. Last updated 26 October 2022.

Last reviewed 2022-10-26 · How we verify

NCT04797728: ELIPSE

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Elacestrant in Preoperative Setting, a Window of Opportunity Study

Completed EARLY_PHASE1 Last updated 26 October 2022

What this trial tests

EARLY_PHASE1 trial testing Elacestrant in Breast Cancer in 23 participants. Completed in 25 February 2022.

Timeline

9 February 2021

Primary endpoint
8 February 2022

25 February 2022

Quick facts

Lead sponsor	SOLTI Breast Cancer Research Group
Phase	EARLY_PHASE1
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	23
Start date	9 February 2021
Primary completion	8 February 2022
Estimated completion	25 February 2022
Sites	4 locations across Spain

Drugs / interventions tested

Elacestrant (ELACESTRANT) — full drug profile →

Conditions studied

Breast Cancer — all drugs for Breast Cancer →
Hormone Receptor Positive Breast Carcinoma — all drugs for Hormone Receptor Positive Breast Carcinoma →

Sponsor

SOLTI Breast Cancer Research Group

Who can join

18 and older, female only, with Breast Cancer or Hormone Receptor Positive Breast Carcinoma. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

ELIPSE is a window of opportunity, prospective, multicenter, phase 0 trial which evaluates the effect of Elacestrant on proliferation after 4 weeks of treatment in postmenopausal women with Estrogen Receptor-positive (ER+) and Human Epidermal Growth Factor Receptor 2-negative (HER2-negative) early breast cancer (BC) amenable to surgery.

Publications & conference data

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

An emerging generation of endocrine therapies in breast cancer: a clinical perspective.
Patel R, Klein P, Tiersten A, Sparano JA. · · 2023 · cited 93× · PMID 37019913 · DOI 10.1038/s41523-023-00523-4
Next-generation selective estrogen receptor degraders and other novel endocrine therapies for management of metastatic hormone receptor-positive breast cancer: current and emerging role.
Lloyd MR, Wander SA, Hamilton E, Razavi P, et al · · 2022 · cited 72× · PMID 35923930 · DOI 10.1177/17588359221113694
Elacestrant: First Approval.
Hoy SM. · · 2023 · cited 48× · PMID 37060385 · DOI 10.1007/s40265-023-01861-0
Oral Selective Estrogen Receptor Degraders (SERDs) in Breast Cancer: Advances, Challenges, and Current Status.
Downton T, Zhou F, Segara D, Jeselsohn R, et al · · 2022 · cited 48× · PMID 36081610 · DOI 10.2147/dddt.s380925
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
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
How I treat endocrine-dependent metastatic breast cancer.
Gombos A, Goncalves A, Curigliano G, Bartsch R, et al · · 2023 · cited 16× · PMID 36806375 · DOI 10.1016/j.esmoop.2023.100882
Oral SERDs alone or in combination with CDK 4/6 inhibitors in breast cancer: Current perspectives and clinical trials.
Apostolidou K, Zografos E, Papatheodoridi MA, Fiste O, et al · · 2024 · cited 9× · PMID 38599049 · DOI 10.1016/j.breast.2024.103729

Verify or expand the search:

Other trials of Elacestrant

Trials testing the same drug.

NCT07242352 — Marker - Adjusted Therapy Comparing Adjuvant Elacestrant With Standard Endocrine Treatment in Genomically and/or Clinica · Phase 3 · not yet recruiting
NCT07222215 — PhII Randomized CAPecitabine + ELAcestrant vs. Capecitabine Alone in ER+ Breast Cancer (CAPELA) · Phase 2 · recruiting
NCT07198724 — ERADICATE: A Phase Ib/II Study of Elacestrant Plus Trastuzumab Deruxtecan in Patients With CDK4/6 Inhibitor and Endocrin · Phase 1, PHASE2 · recruiting
NCT07159451 — A Short-term Preoperative, Evaluating Activity and Safety of Elacestrant Monotherapy as Compared to Elacestrant + Ovaria · Phase 2 · recruiting
NCT07209449 — A Study of Elacestrant Alone or in Combination With Abemaciclib in People With Endometrial Cancer · Phase 2 · recruiting

Other recruiting trials for Breast Cancer

Currently open trials in the same condition.

NCT06148038 — CBD for Breast Cancer Primary Tumors · Phase 1 · recruiting
NCT07405801 — A Phase II Study Evaluating the Efficacy and Safety of Inavolisib Plus Ribociclib Plus Fulvestrant Versus Placebo Plus R · Phase 2 · recruiting
NCT07285993 — Detection and Outcomes in Metastatic Invasive Lobular Breast Cancer Through Novel F-18 FAP PET · Phase 2 · recruiting
NCT07510698 — Same-Day Awake Mastectomy With Immediate Breast Reconstruction for Patients With Breast Cancer · NA · recruiting
NCT06768931 — Biolosion Combined Standard Neoadjuvant Therapy to Treat Triple-negative Breast Cancer · Phase 2 · recruiting

Other SOLTI Breast Cancer Research Group trials

Trials by the same sponsor.

NCT07371585 — Trastuzumab Deruxtecan in First-Line HER2-Positive Metastatic Breast Cancer With Proactive Toxicity Management · Phase 2 · recruiting
NCT06991946 — Patient-Centric Study to Assess the Impact of Genomic Profiling on the Treatment of Patients With Metastatic Breast Canc · recruiting
NCT06236269 — HR+/HER2- Advanced or Metastatic Breast Cancer Patients Treated With Sacituzumab Govitecan · Phase 2 · recruiting
NCT05885009 — Feasibility and Impact of Liquid Biopsy Genomic Profiling on Treatment Patients With Metastatic Prostate Cancer in Spain · recruiting
NCT05569811 — NeoadjuVAnt muLti-agENT Chemotherapy or Patritumab Deruxtecan With or Without endocrINE Therapy for High-risk HR+/HER2- · Phase 2 · active not recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT04797728 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by SOLTI Breast Cancer Research Group
Last refreshed: 26 October 2022

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04797728.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing