Breast CancerPhase 2NCT06568692
A Phase 2 Study of PCS6422 With Capecitabine in Patients With Advanced or Metastatic Breast Cancer
A Phase 2 study testing PCS6422 and capecitabine and Capecitabine in people with Breast Cancer and TNBC - Triple-Negative Breast Cancer, run by Processa Pharmaceuticals at 12 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer, TNBC - Triple-Negative Breast Cancer, HER2-negative Breast Cancer
- What is being tested?
- PCS6422 and capecitabine and Capecitabine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 12 sitesUnited States
- Study dates
- 2 Oct 2024to 29 Jul 2026
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged ≥18 years at Screening
- Diagnosis of histologically confirmed breast cancer that is unresectable. The following subsets of breast cancer are included:
- Patients with triple-negative breast cancer, advanced or metastatic
- Patients with hormone receptor (HR) positive, ER positive, HER2 negative advanced or metastatic breast cancer
- Has measurable disease in accordance with RECIST 1.1 obtained by imaging within 28 days prior to C1D1
- 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
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- Has a life expectance of at least 24 weeks
- Has Eastern Cooperative Oncology Group Performance Status (ECOG PS) 0 or 1 at screening
- 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
Who cannot join
- Received any line of treatment for advanced or metastatic breast cancer within 21 days or 5 half-lives (whichever is longer) prior to randomization
- Currently receiving any hormone replacement therapy, unless discontinued within 21 days prior to randomization
- Received IV 5-FU or oral 5-FU analog in the 4 weeks prior to C1D1
- Received DPD inhibitor within 4 weeks prior to C1D1
- Has homozygous or compound heterozygous DPYD variants that result in complete or near-complete absence of DPD activity
- Cardiac:
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- Has history or presence of clinically significant abnormal 12-lead electrocardiogram (ECG) results, in the Medical Monitor or Investigator's opinion
- Has prolonged QTc (with Fridericia's correction) of >480 msec performed at Screening
- 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
- Has congenital long QT syndrome or a family history of long QT syndrome
- Has other clinically significant cardiac disease including, but not limited to, myocardial infarction, unstable angina, cardiac or other vascular stenting, angioplasty, or surgery ≤12 months prior to randomization, congestive heart failure
- Class II per the New York Heart Association, or history of myocarditis
- Is pregnant or breastfeeding
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
United States12 sites
Texas Oncology PA (Austin)
Austin, Texas, 78731
University of Maryland Medical Center (UMMC)
Baltimore, Maryland, 21201
Gabrail Cancer Center Research
Canton, Ohio, 44718
Northwest Cancer Center
Dyer, Indiana, 46311
Valkyrie Clinical Trials
Los Angeles, California, 90067
AP Medical Research
Miami, Florida, 33165
SCRI Oncology Partners
Nashville, Tennessee, 37203
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, 08901
FOMAT Medical Research
Oxnard, California, 93030
Texas Oncology PA (San Antonio)
San Antonio, Texas, 78240
Moffitt Cancer Center
Tampa, Florida, 33612
Clinical Research Alliance
Westbury, New York, 11590
About this study
Official title: A Phase 2, Open-Label Study of PCS6422 With Capecitabine in Patients With Advanced or Metastatic Breast Cancer
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.
Read the 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.
- Being tested
- PCS6422 and capecitabine, Capecitabine
- Keywords
- HR positive, Advanced Breast Cancer, Metastatic Breast Cancer
- Medical subject headings
- Breast Neoplasms, Triple Negative Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PCS6422 and capecitabineDrug
Also called eniluracil
PCS6422 is an experimental drug that, when combined with capecitabine, may make the immune response more active against cancer.
CapecitabineDrug
Also called xeloda
Commercially available capecitabine is a commonly used oral fluoropyrimidine.
| Study group | Role | What they receive |
|---|---|---|
| PCS6422 40 mg + Capecitabine 300 mg | Experimental | Fixed single dose of PCS6422 administered with Capecitabine 150 mg BID over 7 days Receives: Drug: PCS6422 and capecitabine |
| PCS6422 40 mg + Capecitabine 450 mg or 150 mg | Experimental | Fixed single dose of PCS6422 administered with Capecitabine 225 mg or 75 mg BID over 7 days Receives: Drug: PCS6422 and capecitabine |
| Capecitabine 2000 mg/m2 | Active comparator | Standard capecitabine dose at 1000 mg/m2 BID Receives: Drug: Capecitabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of Objective Response Rate (ORR)
The proportion of patients who achieved a confirmed complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1)
Measured: Up to 24 weeks post End of Treatment (EoT)
Number of patients with adverse events (AEs)
Frequency, duration, and severity of AEs across treatment groups
Measured: During treatment, an average of 8 months
Secondary outcomes (4)
Evaluation of Disease Control Rate (DCR)
The proportion of patients with objective evidence of CR or PR or stable disease (SD) according to RECIST 1.1
Measured: Up to 24 weeks post End of Treatment (EoT)
Evaluation of Duration of Response (DOR)
The proportion of patients with DOR
Measured: Up to 24 weeks post End of Treatment (EoT)
Evaluation of Time to Response (TTR)
The number of patients with days to response
Measured: Every 12 weeks during treatment
Evaluation of Progression Free Survival (PFS)
Patients with number of days of progression free response
Measured: Up to 24 weeks post End of Treatment (EoT)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2024
- Study start2 Oct 2024
- Primary completion29 Jul 2026
- Study completion29 Jul 2026
Why it stopped: Business Reason
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Processa Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mridula George, MD, Principal investigator, Rutgers University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06568692
- Sponsor's protocol ID
- PCS6422-BC-01
- Status last verified
- Oct 2026
- First submitted
- 21 Aug 2024
- Last updated
- 6 Oct 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Open-Label Study of PCS6422 With Capecitabine in Patients With Advanced or Metastatic Breast Cancer
- ClinicalTrials.gov ID
- NCT06568692
- Acronym / sponsor ID
- PCS6422-BC-01
- Keywords
- HR positive, Advanced Breast Cancer, Metastatic Breast Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Business Reason
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Processa PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 2 Oct 2024 (actual)
- Primary completion
- 29 Jul 2026 (actual)
- Study completion
- 29 Jul 2026 (actual)
- First posted
- 23 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| PCS6422 40 mg + Capecitabine 300 mg | Experimental | Drug: PCS6422 and capecitabineFixed single dose of PCS6422 administered with Capecitabine 150 mg BID over 7 days |
| PCS6422 40 mg + Capecitabine 450 mg or 150 mg | Experimental | Drug: PCS6422 and capecitabineFixed single dose of PCS6422 administered with Capecitabine 225 mg or 75 mg BID over 7 days |
| Capecitabine 2000 mg/m2 | Active comparator | Drug: CapecitabineStandard capecitabine dose at 1000 mg/m2 BID |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Aged ≥18 years at Screening
- Diagnosis of histologically confirmed breast cancer that is unresectable. The following subsets of breast cancer are included:
- Has measurable disease in accordance with RECIST 1.1 obtained by imaging within 28 days prior to C1D1
- 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
- Has a life expectance of at least 24 weeks
Key exclusion criteria (13 listed)
- Received any line of treatment for advanced or metastatic breast cancer within 21 days or 5 half-lives (whichever is longer) prior to randomization
- Currently receiving any hormone replacement therapy, unless discontinued within 21 days prior to randomization
- Received IV 5-FU or oral 5-FU analog in the 4 weeks prior to C1D1
- Received DPD inhibitor within 4 weeks prior to C1D1
- Has homozygous or compound heterozygous DPYD variants that result in complete or near-complete absence of DPD activity
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PCS6422 and capecitabineAlso: eniluracilPCS6422 is an experimental drug that, when combined with capecitabine, may make the immune response more active against cancer. | Drug | PCS6422 40 mg + Capecitabine 300 mg, PCS6422 40 mg + Capecitabine 450 mg or 150 mg |
| CapecitabineAlso: xelodaCommercially available capecitabine is a commonly used oral fluoropyrimidine. | Drug | Capecitabine 2000 mg/m2 |
Primary outcome
Evaluation of Objective Response Rate (ORR)
Time frame: Up to 24 weeks post End of Treatment (EoT)
The proportion of patients who achieved a confirmed complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1)
Number of patients with adverse events (AEs)
Time frame: During treatment, an average of 8 months
Frequency, duration, and severity of AEs across treatment groups
4 secondary outcomes
Evaluation of Disease Control Rate (DCR)
Time frame: Up to 24 weeks post End of Treatment (EoT)
Evaluation of Duration of Response (DOR)
Time frame: Up to 24 weeks post End of Treatment (EoT)
Evaluation of Time to Response (TTR)
Time frame: Every 12 weeks during treatment
Evaluation of Progression Free Survival (PFS)
Time frame: Up to 24 weeks post End of Treatment (EoT)
Results and safety
The study was stopped early (reason given: Business Reason). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mridula George, MD principal investigator
Rutgers University
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing PCS6422 and capecitabine and Capecitabine in people with Breast Cancer and TNBC - Triple-Negative Breast Cancer, run by Processa Pharmaceuticals at 12 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 6 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Business Reason). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of Objective Response Rate (ORR) (time frame: Up to 24 weeks post End of Treatment (EoT)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2026.