Trial Watch: Elacestrant + Everolimus in Patients ER+/HER2-, ESR1mut, Advanced Breast Cancer Progressing to ET and CDK4/6i.

Later-Stage HumanInvestigationalNot addressed

Important context

Trial eligibility (participation has strict criteria): Clinical-trial participation has study-specific eligibility criteria; registry listing does not mean a person qualifies or should enroll.

What changed: ClinicalTrials.gov lists Elacestrant + Everolimus in Patients ER+/HER2-, ESR1mut, Advanced Breast Cancer Progressing to ET and CDK4/6i. (NCT06382948) as a Phase 3 interventional cancer study. The registry status is Recruiting, with the record last updated 2026-08-24.

Study snapshot: Phase 3; Recruiting; planned enrollment 300. Conditions listed: Advanced Breast Cancer, ER-positive Breast Cancer, HER2-negative Breast Cancer, ESR1 Gene Mutation. A primary outcome listed by the registry is: To demonstrate superiority of elacestrant+everolimus vs. elacestrant+placebo in prolonging PFS based on a BIRC in patients with ER[+]/HER2[-], ESR1-mutated, ABC that have previously received ET+CDK4/6i (all patients)..

This entry tracks verified trial-registry facts. Trial registration by itself does not show that an intervention is effective, safe for a particular person, FDA-approved for this use, or recommended by clinical guidelines.

What This Means

ClinicalTrials.gov confirms that this Phase 3 study is registered and currently listed as Recruiting. This establishes the study's existence and registry-reported design/status, not a treatment benefit.

What This Doesn't Mean

A registered trial is not proof that the intervention works, is not FDA approval for this cancer or use, and is not a clinical-guideline recommendation.

Why It Matters

Phase 3 trials can contribute later-stage human evidence. CancerDiscoveries can track this record as results and regulatory information emerge.

Promise & Proof

Proof — strength of the evidence 4 / 5

Base score from evidence stage: Later-Stage Human.

Promise — potential significance if later evidence holds up 2 / 5

Baseline — a validly-evidenced story starts here; every further point below is an explicit, checkable reason.
The record includes substantive editorial reasoning about why this discovery matters.

These two ratings are automatically computed from this story's own structured evidence fields and are shown separately on purpose — they are never combined into one score. They describe this record, not a medical recommendation: they do not establish medical certainty, do not substitute for reading the cited sources, and are recalculated whenever the underlying evidence changes.

Population / Applicability

Studied in: Participants age 18 Years and older with Advanced Breast Cancer, ER-positive Breast Cancer, HER2-negative Breast Cancer, ESR1 Gene Mutation who meet the study-specific registry eligibility criteria. (Adults)

Eligibility is study-specific. Registry information does not determine whether any individual should enroll in or receive the intervention.

Full evidence details

Study design: Other / not applicable
Sample size: 300
Primary outcome: To demonstrate superiority of elacestrant+everolimus vs. elacestrant+placebo in prolonging PFS based on a BIRC in patients with ER[+]/HER2[-], ESR1-mutated, ABC that have previously received ET+CDK4/6i (all patients).
Replication: Unknown

Funding & Conflicts

ClinicalTrials.gov lists the lead sponsor as MedSIR. Sponsorship is reported for transparency and does not establish efficacy.

Regulatory status by jurisdiction

Unspecified jurisdiction

Status: Investigational
Last verified: 2026-08-24

This record has no structured cancer-type scope on file yet — editorial review recommended before treating it as applicable to a specific cancer type.

Guideline positions

Guideline

Position: Not addressed
Last verified: 2026-08-24

Primary evidence supporting this story

ClinicalTrials.gov — NCT06382948 (opens in a new tab) (Clinical-trial registry) NCT06382948 Load-bearing source NCT06382948
ClinicalTrials.gov — NCT06382948. NCT06382948.

Why Should I Trust This?

1 source at Tier 1 — Government/regulatory authority (FDA, NCI, NIH, ClinicalTrials.gov, CDC, and equivalent)
Correction/retraction status: No correction or retraction
Last reviewed: 2026-08-24

This panel summarizes real, checkable facts about this record's own sources and review status — it is not a trust score, and reading it is not a substitute for reading the cited sources yourself.

Discovery Timeline

Every recorded change to this record's content or publication status, in order.

2026-08-24 Status change — Status changed from "Legacy / Unverified" to "In editorial review".
2026-08-24 Status change — Status changed from "In editorial review" to "Verified".

Last reviewed 2026-08-24