Study on Abemaciclib for Treating Triple Negative Breast Cancer Resistant to Chemotherapy and Suitable for Surgery

Sponsor: Mayo Clinic

Sponsor score: 60
Inactive

ClinicalTrials ID:NCT03979508

Provider View

This clinical trial is exploring how well the drug abemaciclib works in patients with triple negative breast cancer that can be surgically removed but has not responded to chemotherapy, either alone or with pembrolizumab. Abemaciclib may help by blocking certain enzymes that cancer cells need to grow.

Patient Parameters

Program Overview

This phase II study is testing the effectiveness of abemaciclib in patients with triple negative breast cancer that can be removed by surgery but has not responded to chemotherapy. The study is divided into two groups: one group receives chemotherapy without pembrolizumab, and the other group receives chemotherapy with pembrolizumab. Abemaciclib is believed to work by stopping cancer cells from growing by blocking specific enzymes.

Description

The main goal of this study is to see how abemaciclib affects certain immune cells in patients with chemotherapy-resistant triple negative breast cancer. The study is divided into two groups: one group receives chemotherapy without pembrolizumab, and the other group receives chemotherapy with pembrolizumab. Researchers will also look at the side effects of abemaciclib and how it affects different types of cancer cells and immune cells.

Participants in the study will be assigned to one of two groups:

  • Cohort A: Patients receive chemotherapy without pembrolizumab. Some patients will undergo surgery as usual, while others will take abemaciclib twice daily for a set period before surgery.

  • Cohort B: Patients receive chemotherapy with pembrolizumab. Some patients will undergo surgery as usual, while others will take abemaciclib twice daily for a set period before surgery.

After completing the study treatment, patients will be followed up within 30-60 days to monitor their health and any side effects.

Eligibility Criteria

Inclusion Criteria

  • Women aged 18 years or older.
  • Diagnosed with triple negative breast cancer that can be surgically removed and has not responded to chemotherapy.
  • Willing to undergo a biopsy for research purposes.
  • Able to swallow oral medication.
  • Willing to provide tissue and blood samples for research.
  • Willing to stop using certain medications before the study.
  • Provide written informed consent.
  • Meet specific health criteria, including blood counts and organ function.
  • For women of childbearing potential, a negative pregnancy test is required before starting the study.

Exclusion Criteria

  • History of blood clots or pulmonary embolism within the last 12 months.
  • Previous treatment with CDK 4/6 inhibitors or radiation for this breast cancer.
  • Other active cancers within the last 3 years, except for certain skin or cervical cancers.
  • Serious medical conditions that could interfere with the study.
  • Pregnant or nursing women, or those unwilling to use contraception.
  • Active infections requiring treatment.
  • Concurrent use of certain medications that could interfere with the study.

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