Last reviewed · How we verify
NCT07159451: POP-ELA
A Short-term Preoperative, Evaluating Activity and Safety of Elacestrant Monotherapy as Compared to Elacestrant + Ovarian Function Suppression (LHRH Agonist) in Premenopausal Patients With Stage I-II ER+/HER2- Breast Cancer
Phase 2 trial testing Elacestrant in Breast Cancer in 140 participants. Currently enrolling.
29 January 2027
Quick facts
| Lead sponsor | Gustave Roussy, Cancer Campus, Grand Paris |
|---|---|
| Phase | Phase 2 |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 140 |
| Start date | 6 October 2025 |
| Primary completion | 29 January 2027 |
| Estimated completion | 29 May 2027 |
| Sites | 1 location across France |
Drugs / interventions tested
- Elacestrant (ELACESTRANT) — full drug profile →
- Leuprorelin (leuprorelin) — full drug profile →
Conditions studied
- Breast Cancer — all drugs for Breast Cancer →
Sponsor
Gustave Roussy, Cancer Campus, Grand Paris — full company profile →
Who can join
18 and older, female only, with Breast Cancer. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
A prospective randomized trial designed to evaluate the mean decrease in Ki67 after 4 weeks of elacestrant monotherapy and in combination with leuprorelin in patients with early-stage HR+ BC. This preoperative study will enroll consecutive patients with early stage HR+ BC who are not candidates for neoadjuvant chemotherapy but are eligible for short-term preoperative treatment with elacestrant, with or without leuprorelin, followed by breast surgery. A total of three dedicated Formalin-fixed paraffin embedded (FFPE) samples (mandatory for all patients), along with two frozen biopsy (only for participants at Gustave Roussy), are planned to be collected at the time of inclusion from the biopsy sample and from the surgical specimen. Blood samples will also be collected throughout the study.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT07159451
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
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
- NCT07209449 — A Study of Elacestrant Alone or in Combination With Abemaciclib in People With Endometrial Cancer · Phase 2 · recruiting
- NCT07005882 — Hormonal Receptor (HR)-Positive HER2 Negative Breast Cancer Patients Treated With Preoperative ELacestrant and PULSAR Ra · Phase 2 · not yet 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 Gustave Roussy, Cancer Campus, Grand Paris trials
Trials by the same sponsor.
- NCT07303387 — Efficacy and Safety of the Valemetostat in Patients With Selected Solid Tumors. · Phase 2 · not yet recruiting
- NCT06781996 — A Study to Determine the Efficacy of a Digital Self-management Support Tool to Improve the Quality of Life During Adjuva · Phase 3 · recruiting
- NCT07016230 — Study Investigating Tarlatamab (AMG 757) in Patients With Metastatic/Locally Advanced Small-Cell Lung Cancer (SCLC) and · Phase 2 · recruiting
- NCT06902883 — Study on the Effectiveness and Comfort of Innovative Solutions for the Internal Transport of Patients in Wheelchairs in · Phase 2 · completed
- NCT06713798 — Targeting PD-L1 and TIGIT in Tumors With Tertiary Lymphoid Structures · Phase 2 · withdrawn
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT07159451 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Gustave Roussy, Cancer Campus, Grand Paris
- Last refreshed: 1 December 2025
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/NCT07159451.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing