Study of Abemaciclib and Elacestrant for Patients with Brain Metastasis from ER+/HER-2- Breast Cancer

Sponsor: Stemline Therapeutics, Inc.

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT05386108

Provider View

This clinical trial is exploring a new treatment combination of Abemaciclib and Elacestrant for patients with brain metastases from estrogen receptor-positive, HER-2 negative breast cancer. The study aims to determine the best dose and evaluate the treatment's effectiveness.

Patient Parameters

Program Overview

This global study is testing a combination of two drugs, Abemaciclib and Elacestrant, in patients with brain metastases from ER-positive, HER-2 negative breast cancer. The study is divided into two phases: Phase 1b, which focuses on finding the best dose, and Phase 2, which evaluates the treatment's effectiveness in patients with active brain metastases.

Eligibility Criteria

Inclusion Criteria

  • Signed informed consent before any study activities.
  • Women or men aged 18 years or older.
  • Women can be postmenopausal or pre/perimenopausal.
  • Must have ER-positive, HER-2 negative breast cancer confirmed by lab tests.
  • In Phase 2, must have at least one active and measurable brain metastasis.
  • Stable or decreasing corticosteroid dose for at least 7 days before starting the study.
  • Stable neurological symptoms for at least 2 weeks before starting the study.
  • Previous treatment in the metastatic setting must include at least one endocrine therapy and up to two chemotherapy regimens.
  • Documented progression or recurrence of cancer.
  • ECOG performance status of 0 to 2.
  • Adequate bone marrow and organ function based on specific lab tests.
  • Willingness to follow study visit schedule and requirements.

Exclusion Criteria

  • Immediate need for CNS-specific treatment.
  • Imminent organ failure or visceral crisis.
  • Leptomeningeal metastases.
  • No prior treatment for advanced/metastatic breast cancer.
  • Previous use of Abemaciclib in the metastatic setting.
  • Previous use of Elacestrant or similar investigational drugs.
  • Another cancer within 3 years, except for certain skin or cervical cancers.
  • Participation in another breast cancer study.
  • Recent anti-cancer treatment within specified timeframes.
  • Uncontrolled infections or significant medical conditions.
  • Major surgery within 4 weeks of starting the study.
  • Inability to take oral medication or gastrointestinal issues.
  • Women of childbearing potential not using effective contraception.
  • Men not using effective contraception with partners of childbearing potential.
  • Pregnant or breastfeeding women.
  • Known intolerance to study drugs.
  • Recent use of certain medications or herbal supplements.
  • Recent vaccination, including COVID-19, within 7 days before starting the study.
  • Severe medical or psychiatric conditions that may affect participation.

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