Phase Ib/II Study of Abemaciclib and Elacestrant for Brain Metastasis in HR+/Her2- Breast Cancer Patients

Sponsor: Criterium, Inc.

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT04791384

Provider View

This clinical trial is testing a combination of two drugs, abemaciclib and elacestrant, to see if they can help treat breast cancer that has spread to the brain in patients with HR+/Her2- breast cancer. Participants may have had up to two previous chemotherapy treatments for advanced cancer.

Patient Parameters

Program Overview

The study aims to find out if the combination of abemaciclib and elacestrant can effectively treat breast cancer that has spread to the brain in patients with HR+/Her2- breast cancer. Participants can have had up to two prior chemotherapy treatments for advanced cancer, but there is no limit on previous hormone therapies like aromatase inhibitors, tamoxifen, and fulvestrant. The trial will start with a small group to ensure safety before expanding to more participants if the treatment shows promise.

Description

This study involves taking two medications: abemaciclib, taken twice daily at 150 mg, and elacestrant, taken once daily at 400 mg. If side effects occur, the doses may be reduced up to two times. The study will monitor participants for any side effects and assess them using standard criteria. Initially, 10 patients will be enrolled to evaluate safety. If at least three patients show a positive response, the study will continue to enroll more participants. The trial is open to post-menopausal women with HR+/Her2- breast cancer that has spread to the brain, who have measurable brain tumors and have previously received up to two chemotherapy treatments for advanced cancer. Participants must be able to take oral medications and have adequate organ function. Women of childbearing potential must use effective contraception during the study and for 30 days after the last dose.

Eligibility Criteria

Inclusion Criteria

  • Post-menopausal women with HR+/Her2- breast cancer that has spread to the brain.
  • Must have measurable brain tumors.
  • Can have had up to two previous chemotherapy treatments for advanced cancer.
  • Must be able to take oral medications.
  • Must have adequate organ function as determined by specific blood tests.
  • Women of childbearing potential must use effective contraception during the study and for 30 days after the last dose.
  • Must provide a tumor tissue sample for analysis.
  • Must understand the study requirements and provide informed consent.

Exclusion Criteria

  • Pregnant or breastfeeding women.
  • Patients under 18 years old.
  • Previous use of abemaciclib or elacestrant.
  • Serious preexisting medical conditions that could interfere with the study.
  • Active infections requiring IV antibiotics.
  • History of certain heart conditions.
  • More than two seizures in the last four weeks.
  • Uncontrolled serious medical or psychiatric illness.
  • Conditions that impair taking oral medications.
  • Another cancer diagnosed within the last five years, except for certain skin or cervical cancers.
  • Currently receiving other investigational treatments.

Get This Program In Your Inbox

Receive detailed information about this treatment opportunity to review with your healthcare provider.