Phase II Study of CMC Regimen for Early Stage Breast Cancer

Sponsor: University of Illinois at Chicago

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT06085742

Provider View

This clinical trial is testing a new oral chemotherapy treatment called CMC for patients with early stage breast cancer. The study aims to see if this treatment is effective and safe when given before surgery.

Patient Parameters

Program Overview

This study is exploring a new oral chemotherapy treatment called CMC for patients with early stage breast cancer. The trial is designed to see if this treatment can be safely and effectively used before surgery. Participants may also receive radiation therapy as part of their treatment plan. The study will monitor how well patients follow the treatment plan and check their health through regular lab tests.

Description

Participants in this study will receive a new oral chemotherapy treatment called CMC. If radiation therapy is needed, it can be started after the fourth cycle of CMC, with the remaining cycles paused during radiation. After completing radiation, participants can resume the CMC treatment. There is a required break of at least two weeks before and after radiation therapy. Alternatively, radiation can be given after all eight cycles of CMC are completed.

The study team will collect information on how well participants are following the treatment plan and will conduct regular lab tests to monitor their health. These tests will include checking electrolytes, liver function, and other important health markers.

Eligibility Criteria

Inclusion Criteria

  • Must be 18 years or older.
  • Have a good overall health status (ECOG score of 0, 1, or 2).
  • Have a confirmed diagnosis of invasive breast cancer through biopsy or surgery.
  • Have had surgery to remove the breast tumor with no remaining cancer, except for small areas that can be treated with radiation.
  • No signs of cancer spread to distant parts of the body.
  • Oncologist recommends chemotherapy without other targeted treatments. Some additional treatments may be allowed after the study.
  • Tumor must be hormone receptor-positive and HER2-negative.
  • High-risk gene expression profile or clinical high-risk tumor based on specific criteria.
  • Adequate organ function based on lab tests.
  • Able to provide informed consent and follow study procedures.
  • Women of childbearing potential must use effective birth control and have a negative pregnancy test.
  • Meet specific blood count and organ function requirements.

Exclusion Criteria

  • Have had chemotherapy for this breast cancer before.
  • Have taken investigational drugs recently.
  • Have advanced stage breast cancer (stage IIIB-IIIC or stage IV).
  • Have an active infection needing treatment.
  • Have uncontrolled HIV/AIDS or active hepatitis.
  • Are pregnant or breastfeeding.
  • Need to take warfarin for blood thinning (other blood thinners may be allowed).
  • Have another cancer that could interfere with this study.
  • Have a mental or medical condition that prevents participation.
  • Have a major health issue that could affect the study.
  • Cannot swallow pills or have a condition affecting medication absorption.
  • Have a contraindication to any drug in the CMC regimen.
  • Are taking medications that affect the study drugs.
  • Are a prisoner.
  • Are unable or unwilling to take a large number of pills.

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