RecruitingPhase 2interventionalRules rewrite

Phase 2: testing elacestrant, palbociclib, abemaciclib, ribociclib for Estrogen-receptor-positive Breast Cancer

Breast cancer is not only the leading cause of cancer in women, but also the leading cause of cancer deaths in women. Estrogen receptor-positive and HER2-negative breast cancer is the most prevalent breast cancer subtype.

Official registry: https://clinicaltrials.gov/study/NCT06062498 · Northwestern University · enrollment listed as 174

What this phase means

Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.

Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

What the registry says happens

If you join, the listed intervention(s) are elacestrant, palbociclib, abemaciclib, ribociclib. The registry lists allocation as randomized. Breast cancer is not only the leading cause of cancer in women, but also the leading cause of cancer deaths in women.

They plan to enroll about 174 people at 3 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.

Official title (unrewritten)

Randomized Phase II Study of Elacestrant vs Elacestrant Plus a CDK4/6 Inhibitor (Palbociclib, Abemaciclib, or Ribociclib) in Patients With ER+/HER2- Advanced or Metastatic Breast Cancer With Prior Exposure to a CKD4/6 Inhibitor

Interventions: elacestrant, palbociclib, abemaciclib, ribociclib

Primary outcome (registry wording): Progression-Free Survival (PFS)

Who it is for (from inclusion criteria)

Ages 18 Years to any
Patients must have histologically or cytologically confirmed ER-positive and HER2- negative breast cancer as per the American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) guidelines (Allison et al, 2020, Wolff et al, 2018)
Note: In the context of this trial, ER status will be considered positive if \>10% of tumor cells demonstrate positive nuclear staining by immunohistochemistry. Note: Fresh biopsy is not a requirement
Patients must have a confirmed ESR1 mutation. Note: This information will be drawn from patients' treatment charts. Mutational analysis will be done as standard of care; there is no research-related mutational testing for this study. ctDNA may be used for mutational testing
Patients must have received at least 2 prior endocrine therapies, including a CDK4/6 inhibitor in the metastatic disease setting
Patients must be age ≥ 18 years. Patients of childbearing potential (POCBP) may be premenopausal, postmenopausal, or perimenopausal
Potential POCBP who may be menopausal and are \< 55 years of age must have a serum follicle-stimulating hormone (FSH) level \> 40 mIU/mL to confirm menopause
Patients must exhibit an how well you can do daily activities (ECOG score) of 0 or 1

Who the registry excludes

Patients who have received prior elacestrant
Patients who have had chemotherapy or radiotherapy ≤ 28 days (6 weeks for nitrosureas or mitomycin C) prior to registration
Patients who have taken steroid therapy or any other immunosuppressive therapy within 7 days of first dose prior to trial treatment
Patients who have not recovered from side effects due to prior anti-cancer therapy (i.e., have residual toxicities \> Grade 3) with the exception of alopecia
Patients who are receiving any other investigational agents. For patients who were previously on palbociclib, abemaciclib, or ribociclib, the washout period between stopping that CDK4/6 inhibitor and starting a different one is 14 days
Patients with advanced, symptomatic visceral spread who are at risk of life-threatening complications in the short term, including massive uncontrolled effusions (peritoneal, pleural, pericardial), pulmonary lymphangitis, or liver involvement \>50%
Patients with documented pneumonitis/interstitial lung disease prior to registration

Public study contact (from the registry)

Study Coordinator

3126951301

cancer@northwestern.edu

Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.

Sites listed on ClinicalTrials.gov

3 listed

Northwestern University — Chicago, Illinois (recruiting)
Rush University Medical Center — Chicago, Illinois (not_yet_recruiting)
University of Chicago — Chicago, Illinois (recruiting)

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FAQ about this NCT record

Is NCT06062498 still recruiting?

The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.

What phase is NCT06062498?

Phase 2. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

Can PlainTrials tell me if I qualify for NCT06062498?

No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.

How to read a ClinicalTrials.gov record · Questions to ask the coordinator · Glossary