Phase 2 Study of PCS6422 with Capecitabine for Advanced or Metastatic Breast Cancer

Sponsor: Processa Pharmaceuticals

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT06568692

Provider View

This clinical trial is testing a new combination of drugs, PCS6422 and Capecitabine, to see if they can effectively treat advanced or metastatic breast cancer in patients who cannot use other common treatments.

Patient Parameters

Program Overview

The study aims to evaluate the effectiveness and safety of combining PCS6422 with Capecitabine compared to using Capecitabine alone in patients with advanced or metastatic breast cancer. This trial is for patients who cannot use other treatments like anthracyclines, taxanes, PD-1, or PARP inhibitors.

Description

This clinical trial is exploring a new treatment option for patients with advanced or metastatic breast cancer. The study is testing a combination of two drugs, PCS6422 and Capecitabine, to see if they work better together than Capecitabine alone. The trial is open to patients who have already received chemotherapy for their metastatic cancer and cannot use other treatments like anthracyclines or taxanes. The study will take place at multiple centers and will involve random assignment to different treatment groups to compare the outcomes.

Eligibility Criteria

Inclusion Criteria

  • Must be 18 years or older.
  • Have a confirmed diagnosis of breast cancer that cannot be surgically removed.
  • Includes patients with triple-negative breast cancer or hormone receptor-positive, HER2-negative breast cancer.
  • Must have measurable cancer as shown by recent imaging tests.
  • Other treatments are not suitable due to resistance or intolerance.
  • Expected to live at least 24 weeks.
  • Must be in good general health with a performance status of 0 or 1.
  • Must have adequate bone marrow, liver, and kidney function based on recent lab tests.
  • Must not have received certain treatments or medications recently.
  • Must not be pregnant or breastfeeding.

Exclusion Criteria

  • Have received treatment for advanced or metastatic breast cancer within the last 21 days or longer, depending on the drug's half-life.
  • Currently on hormone replacement therapy unless stopped 21 days before the study.
  • Have used certain chemotherapy drugs or DPD inhibitors recently.
  • Have specific genetic variants affecting drug metabolism.
  • Have significant heart problems, including abnormal ECG results, prolonged QT interval, or history of serious heart conditions.
  • Have a history of heart disease, recent heart attack, or heart surgery within the last year.
  • Are pregnant or breastfeeding.

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