Study on Imlunestrant and Abemaciclib for Treating Estrogen Receptor Positive Breast Cancer with Minimal Residual Disease

Sponsor: Jonsson Comprehensive Cancer Center

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT07191717

Provider View

This clinical trial is exploring how well the combination of two drugs, imlunestrant and abemaciclib, works in treating patients with estrogen receptor positive breast cancer who have small amounts of cancer remaining in their blood after treatment.

Patient Parameters

Program Overview

The purpose of this study is to see if the drugs imlunestrant and abemaciclib can help treat patients with estrogen receptor positive (ER+) breast cancer who still have some cancer cells in their blood after previous treatments. Estrogen can help breast cancer cells grow, and imlunestrant works by reducing the amount of estrogen in the body. Abemaciclib helps stop cancer cells from growing by blocking certain enzymes. This study will test if these drugs can effectively treat patients with minimal residual disease.

Description

The main goal of this study is to find out how well the combination of imlunestrant and abemaciclib clears cancer DNA from the blood after 12 cycles of treatment. Researchers will also look at how safe and tolerable the treatment is, and how often cancer DNA reappears in the blood after treatment. Additionally, the study will evaluate how long patients remain free from distant cancer recurrence or death over a year.

Participants will take abemaciclib twice a day and imlunestrant once a day for 28 days in each cycle, repeating for up to 12 cycles unless the cancer progresses or side effects become too severe. Blood samples will be collected throughout the study, and some patients may have scans as needed. After finishing the treatment, participants will have follow-up visits 30 days later and then every four months for a year.

Eligibility Criteria

Inclusion Criteria

  • Have localized estrogen receptor positive (ER+) and HER2 negative breast cancer, confirmed by lab tests.
  • Have detectable cancer DNA in the blood within the last six months, with no signs of cancer recurrence.
  • Provide a sample of tumor tissue from a previous biopsy or surgery.
  • No history of other cancers in the last five years, except for certain non-threatening types.
  • May have received previous chemotherapy or biological therapy, with minimal side effects remaining.
  • May have received previous radiotherapy, with minimal side effects remaining.
  • Both premenopausal and postmenopausal women and men are eligible. Premenopausal women must have a negative pregnancy test.
  • Be 18 years or older.
  • Have not used CDK 4/6 inhibitors in the last six months.
  • Be in good overall health with a performance status score of 0 or 1.
  • Currently receiving and have been on adjuvant endocrine therapy for at least two years.
  • Meet specific blood count and organ function requirements.
  • Able to swallow oral medications.

Exclusion Criteria

  • Have metastatic or inflammatory breast cancer.
  • Have used CDK 4/6 inhibitors in the last six months.
  • Are receiving other anti-cancer investigational treatments.
  • Have a history of other cancers in the last five years, except for certain non-threatening types.
  • Use herbal products or supplements, unless approved by the study leader.
  • Have uncontrolled illnesses or infections that could interfere with the study.
  • Have a history of severe heart conditions or blood clots.
  • Are allergic to imlunestrant, abemaciclib, or their components.
  • Are HIV-positive and not on antiretroviral therapy.
  • Are pregnant or breastfeeding, or not using effective contraception if of childbearing potential.

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