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A Phase 2 Study of PCS6422 With Capecitabine in Patients With Advanced or Metastatic Breast Cancer | Clinical Trials | Clareo Health

RECRUITINGPHASE2

A Phase 2 Study of PCS6422 With Capecitabine in Patients With Advanced or Metastatic Breast Cancer

A Phase 2, Open-Label Study of PCS6422 With Capecitabine in Patients With Advanced or Metastatic Breast Cancer

NCT06568692•Processa Pharmaceuticals

View on ClinicalTrials.gov

Summary

This is an adaptive Phase 2, open-label, randomized, multi-center study evaluating up to 2 regimens of PCS6422 with capecitabine (Cap) vs. standard dose of Cap alone in patients with advanced or metastatic breast cancer. The goal of the study is to assess the efficacy and safety of PCS6422 + Cap as a treatment option for patients with advanced or metastatic breast cancer who are not eligible for anthracycline- or taxane-containing therapies, or other available therapies, including PD-1 or PARP inhibitors.

Detailed Description

This is an adaptive Phase 2, open-label, randomized, multi-center study evaluating up to 2 regimens of PCS6422 with Cap vs. standard dose of Cap alone in patients with advanced or metastatic breast cancer who are not eligible for anthracycline- or taxane-containing therapies, or other available therapies, including PD-1 or PARP inhibitors. The goal of the study is to assess the efficacy and safety of PCS6422 + Cap as a treatment option for patients with advanced or metastatic breast cancer who have been treated with chemotherapy in the metastatic setting.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Aged ≥18 years at Screening
•2. Diagnosis of histologically confirmed breast cancer that is unresectable. The following subsets of breast cancer are included:
•1. Patients with triple-negative breast cancer, advanced or metastatic
•2. Patients with hormone receptor (HR) positive, ER positive, HER2 negative advanced or metastatic breast cancer
•3. Has measurable disease in accordance with RECIST 1.1 obtained by imaging within 28 days prior to C1D1
•4. Other therapies are not indicated (eg, resistant or intolerant to taxanes and/or an anthracycline-containing regimen) for treatment of advanced or metastatic breast cancer
•5. Has a life expectance of at least 24 weeks
•6. Has Eastern Cooperative Oncology Group Performance Status (ECOG PS) 0 or 1 at screening
•7. Has adequate bone marrow, liver, and renal function as assessed by the following laboratory requirements conducted within 7 days before C1D1 (Note: labs will also be repeated pre-dose on C1D1 to confirm eligibility): a. Hemoglobin ≥9 g/dL (≥90 g/L) b. Adequate renal function by estimated glomerular filtration rate (eGFR) defined as a creatinine clearance \>50 mL/min (\>0.84 mL/s) (Cockcroft-Gault equation) and normalized to body surface area c. Peripheral absolute neutrophil count (ANC) of ≥1.5×109/L d. Platelet count of ≥100×109/L without growth factor/transfusion e. Total bilirubin \<1.5× upper limit of normal (ULN); or ≤3×ULN if the patient has Gilbert's disease f. Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \<2.5×ULN, with liver metastasis \<5×ULN g. International normalized ratio (INR) \<1.5 and prothrombin time (PT) ≤1.5×ULN, unless both of the following conditions are met: i. Patient is receiving anticoagulant therapy, and ii. PT or partial thromboplastin time (PTT) is within therapeutic range of intended use of anticoagulant h. Activated partial thromboplastin time (aPTT) ≤1.5×ULN, unless both of the following conditions are met: i. Patient is receiving anticoagulant therapy, and ii. PT or PTT is within therapeutic range of intended use of anticoagulants

Exclusion Criteria

•1. Received any line of treatment for advanced or metastatic breast cancer within 21 days or 5 half-lives (whichever is longer) prior to randomization
•2. Currently receiving any hormone replacement therapy, unless discontinued within 21 days prior to randomization
•3. Received IV 5-FU or oral 5-FU analog in the 4 weeks prior to C1D1
•4. Received DPD inhibitor within 4 weeks prior to C1D1
•5. Has homozygous or compound heterozygous DPYD variants that result in complete or near-complete absence of DPD activity
•6. Cardiac:
•1. Has history or presence of clinically significant abnormal 12-lead electrocardiogram (ECG) results, in the Medical Monitor or Investigator's opinion
•2. Has prolonged QTc (with Fridericia's correction) of \>480 msec performed at Screening
•3. Has a history of prolonged QTc interval, ventricular tachycardia/fibrillation or significant ventricular arrhythmia, or Torsades de Pointes, or a history of ventricular ablation for arrhythmia
•4. Has congenital long QT syndrome or a family history of long QT syndrome
+3 more criteria

Locations (13)

Arizona Oncology Associates

Tucson, Arizona, United States

Valkyrie Clinical Trials

Los Angeles, California, United States

FOMAT Medical Research

Oxnard, California, United States

AP Medical Research

Miami, Florida, United States

Moffitt Cancer Center

Tampa, Florida, United States

Northwest Cancer Center

Dyer, Indiana, United States

University of Maryland Medical Center (UMMC)

Baltimore, Maryland, United States

Rutgers Cancer Institute of New Jersey

New Brunswick, New Jersey, United States

Clinical Research Alliance

Westbury, New York, United States

Gabrail Cancer Center Research

Canton, Ohio, United States

Key Dates

Start Date

October 2, 2024

Primary Completion Date

September 1, 2026

Completion Date

October 1, 2026

Last Updated

June 19, 2025

Enrollment

ESTIMATED participants

Conditions

Breast CancerTNBC - Triple-Negative Breast CancerHER2-negative Breast Cancer

Interventions

PCS6422 and capecitabine

DRUG

Capecitabine

DRUG

Contacts

Sian Bigora, PharmD

CONTACT

410-693-6844 sbigora@processapharmaceuticals.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: June 19, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

A Phase 2 Study of PCS6422 With Capecitabine in Patients With Advanced or Metastatic Breast Cancer

Inclusion Criteria

Exclusion Criteria

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