Study on Fulvestrant and Abemaciclib with Initial Fulvestrant Treatment for ER-Positive, HER2-Negative Metastatic Breast Cancer

Sponsor: The Methodist Hospital Research Institute

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT05305924

Provider View

This clinical trial is exploring whether taking a break from the drug abemaciclib before combining it with fulvestrant can improve treatment outcomes for patients with ER-positive, HER2-negative metastatic breast cancer that has progressed after previous treatments.

Patient Parameters

Program Overview

The study aims to find out if pausing the use of the drug abemaciclib for one month can make the combination of abemaciclib and fulvestrant more effective in treating ER-positive, HER2-negative metastatic breast cancer that has worsened after standard treatments. Patients will first receive fulvestrant alone for one month, followed by both fulvestrant and abemaciclib every 28 days. Treatment will continue until the cancer progresses or side effects become unacceptable.

Description

This study focuses on patients with ER-positive, HER2-negative metastatic breast cancer, a type of cancer that often spreads and becomes resistant to standard treatments like endocrine therapy. The research is testing whether a one-month break from the drug abemaciclib can help reset the cancer cells' response, making the subsequent combination of abemaciclib and fulvestrant more effective.

Participants will first receive the drug fulvestrant for one month. After this period, they will start receiving both fulvestrant and abemaciclib every 28 days. The treatment will continue until the cancer shows signs of progression or if the side effects become too severe to manage.

This is a single-arm study, meaning all participants will receive the same treatment. The goal is to see if this approach can offer a new strategy for managing this type of breast cancer, especially for those who have already tried other treatments without success.

Eligibility Criteria

Inclusion Criteria

  • Must be 18 years or older.
  • Cancer has progressed after treatment with a CDK4/6 inhibitor and an aromatase inhibitor.
  • Diagnosed with ER-positive, HER2-negative metastatic breast cancer.
  • Have measurable disease or bone-only disease.
  • Must be postmenopausal or receiving ovarian suppression therapy.
  • Good overall health with a performance status of 0 or 1.
  • Life expectancy of at least 6 months.
  • Must have recovered from any previous chemotherapy or radiotherapy.
  • Adequate organ function as shown by specific blood tests.
  • Able to swallow pills.
  • Women must use effective contraception during the study and for one year after treatment.
  • Must provide written informed consent to participate.

Exclusion Criteria

  • Currently in another study or have been in one recently.
  • Recent chemotherapy, targeted therapy, or radiation therapy.
  • Have another progressing cancer that needs treatment.
  • Have serious medical conditions that could interfere with the study.
  • Have psychiatric or substance abuse issues that could affect participation.
  • Taking certain medications that interact with the study drugs.
  • Allergic to fulvestrant or abemaciclib.
  • Have digestive issues that affect medication absorption.
  • Have bleeding disorders or are on blood thinners.
  • Have active hepatitis B or C, or HIV.
  • Have untreated or symptomatic brain metastases.
  • Have had a live vaccine recently.
  • Pregnant or breastfeeding.

Get This Program In Your Inbox

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