NCT06691035 is a Phase 1 clinical trial of Elacestrant in Breast Cancer Metastatic Breast Cancer, sponsored by H. Lee Moffitt Cancer Center and Research Institute.

Who is sponsoring NCT06691035?

NCT06691035 is sponsored by H. Lee Moffitt Cancer Center and Research Institute.

What drugs are being tested in NCT06691035?

Interventions in NCT06691035: Elacestrant, DC1 native/mutated ESR1.

What condition does NCT06691035 study?

NCT06691035 studies Breast Cancer Metastatic Breast Cancer, HER2-negative Breast Cancer.

Is NCT06691035 still recruiting?

NCT06691035 is currently recruiting now. Last updated 3 December 2025.

Last reviewed 2025-12-03 · How we verify

NCT06691035

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

Immunologic Targeting of Native and Mutated ESR1 Receptor for Treatment of Hormone Receptor Expressing Metastatic Breast Cancer

Recruiting now Phase 1 Last updated 3 December 2025

What this trial tests

Phase 1 trial testing Elacestrant in Breast Cancer Metastatic Breast Cancer in 18 participants. Currently enrolling.

Timeline

4 November 2024

Primary endpoint
1 November 2026

1 November 2027

Quick facts

Lead sponsor	H. Lee Moffitt Cancer Center and Research Institute
Phase	Phase 1
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	18
Start date	4 November 2024
Primary completion	1 November 2026
Estimated completion	1 November 2027
Sites	1 location across United States

Drugs / interventions tested

Elacestrant (ELACESTRANT) — full drug profile →
DC1 native/mutated ESR1 — full drug profile →

Conditions studied

Breast Cancer Metastatic Breast Cancer — all drugs for Breast Cancer Metastatic Breast Cancer →
HER2-negative Breast Cancer — all drugs for HER2-negative Breast Cancer →

Sponsor

H. Lee Moffitt Cancer Center and Research Institute

Who can join

18 and older, any sex, with Breast Cancer Metastatic Breast Cancer or HER2-negative Breast Cancer. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Rate of Successful Completion
Time frame: Up to 2 years
Feasibility: Defined as a patient's ability and willingness to complete the treatment regimen (8 weeks) to End of Treatment (EOT) (window of + 30 days from date of last study treatment). Data collection will include rate of successful completion.
Occurrence Rate
Time frame: Up to 2 years
Feasibility: Defined as a patient's ability and willingness to complete the treatment regimen (8 weeks) to End of Treatment (EOT) (window of + 30 days from date of last study treatment). Data collection will include occurrence rate for each reason stated for non-completion.
Occurrence of Treatment Related Adverse Events
Time frame: Up to 2 years
Number of participants with treatment related adverse events, per event category.

Sponsor's own description

This is a pilot study to determine feasibility and safety of the combination of Dendritic Cell (DC1) vaccines and elacestrant in patients with hormone positive HER2 negative metastatic breast cancer.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

Pipe dream to pipeline: Journey of cancer vaccines and the road ahead.
Onkar S, Bozkus CC, Saxena M, Bhardwaj N. · · 2026 · cited 1× · PMID 41576943 · DOI 10.1016/j.xcrm.2025.102575

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 H. Lee Moffitt Cancer Center and Research Institute trials

Trials by the same sponsor.

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NCT07222995 — Hybrid Effectiveness-Implementation Trial to Integrate Precision Skin Cancer Risk Feedback in FQHCs · NA · recruiting
NCT06047977 — Tumor Infiltrating Lymphocyte Therapy for Pediatric High Risk Solid Tumors · Phase 1 · recruiting
NCT06121180 — Study of Cemiplimab Plus Ziv-Aflibercept for Subjects With Metastatic Uveal Melanoma · Phase 2 · recruiting
NCT06193486 — Autologous Gamma Delta T Cells to Target Prostate Stem Cell Antigen in mCRPC · Phase 1 · 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 NCT06691035 (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 H. Lee Moffitt Cancer Center and Research Institute
Last refreshed: 3 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/NCT06691035.

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