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Anti-metabolites

PCS6422 + Capecitabine for Breast Cancer

Westbury, NY
Phase 2
Recruiting
Research Sponsored by Processa Pharmaceuticals
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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 Eastern Cooperative Oncology Group Performance Status (ECOG PS) 0 or 1 at screening
Must not have
Has homozygous or compound heterozygous DPYD variants that result in complete or near-complete absence of DPD activity
Received IV 5-FU or oral 5-FU analog in the 4 weeks prior to C1D1
Timeline
Screening 3 weeks
Treatment Varies
Follow Up during treatment, an average of 8 months
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing a new treatment, PCS6422, in combination with capecitabine for patients with advanced breast cancer. The goal is to see if this new treatment is effective and safe

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Who is the study for?
This trial is for individuals with advanced or metastatic breast cancer who can't have treatments like anthracyclines, taxanes, PD-1 or PARP inhibitors. Participants should be able to take oral medication and have acceptable blood test results.Check my eligibility
What is being tested?
The study compares two treatment regimens: PCS6422 combined with capecitabine versus the standard dose of capecitabine alone. It's an open-label and randomized trial, meaning both patients and researchers know which treatment is given and participants are assigned by chance.See study design
What are the potential side effects?
Capecitabine may cause side effects such as diarrhea, hand-foot syndrome (redness/pain in hands/feet), nausea, fatigue. The combination with PCS6422 could potentially alter these effects or introduce new ones.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My breast cancer is advanced, cannot be surgically removed, and falls into one of the specified categories.
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I am fully active or restricted in physically strenuous activity but can do light work.
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I am 18 years old or older.
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I cannot use certain common treatments for my advanced breast cancer due to resistance or intolerance.
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Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have a genetic condition that almost completely lacks DPD enzyme activity.
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I have received 5-FU or a similar medication through IV or orally in the last 4 weeks.
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I haven't had treatments for advanced breast cancer in the last 21 days or 5 half-lives.
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I have stopped any hormone replacement therapy at least 21 days ago.
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Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~during treatment, an average of 8 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and during treatment, an average of 8 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Evaluation of Objective Response Rate (ORR)
Number of patients with adverse events (AEs)
Secondary study objectives
Evaluation of Disease Control Rate (DCR)

Side effects data

From 2021 Phase 3 trial • 693 Patients • NCT02028507
63%
Neutrophil count decreased
51%
Fatigue
37%
Hypertension
25%
Nausea
23%
Weight loss
19%
Back pain
17%
Mucositis
17%
Headache
17%
Diarrhea
16%
Weight gain
15%
Vomiting
13%
Arthralgia
13%
Hypothermia
12%
Anorexia
12%
Alopecia
11%
Anemia
11%
Upper respiratory infection
11%
Cough
10%
Flu like symptoms
10%
Obesity
9%
Pain in extremity
9%
Constipation
8%
Fever
7%
Dyspepsia
7%
Dizziness
7%
Hot flashes
7%
Bone pain
7%
Pruritus
5%
Dysgeusia
5%
Pain
3%
Nail disorder
3%
Abdominal pain
3%
Respiratory infection
1%
Dyspnea
1%
Renal failure
1%
Bronchial infection
1%
Heart failure
1%
Breast infection
1%
Pleural effusion
1%
Dislocation of hip
1%
Osteonecrosis of jaw
1%
Spinal cord compression
1%
Gallbladder infection
1%
Ascites
1%
Palmar-plantar erythrodysesthesia syndrome
1%
Cholecystitis acute
1%
Urinary tract infection
1%
Thromboembolic event
1%
Gastrointestinal infection
100%
80%
60%
40%
20%
0%
Study treatment Arm
Cohort 2: Palbociclib Plus Fulvestrant
Cohort 1 and 2: Capecitabine
Cohort 1: Palbociclib Plus Exemestane

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups
Experimental Treatment
Active Control
Group I: PCS6422 40 mg + Capecitabine 450 mg or 150 mgExperimental Treatment1 Intervention
Fixed single dose of PCS6422 administered with Capecitabine 225 mg or 75 mg BID over 7 days
Group II: PCS6422 40 mg + Capecitabine 300 mgExperimental Treatment1 Intervention
Fixed single dose of PCS6422 administered with Capecitabine 150 mg BID over 7 days
Group III: Capecitabine 2000 mg/m2Active Control1 Intervention
Standard capecitabine dose at 1000 mg/m2 BID
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
PCS6422 and capecitabine
2021
Completed Phase 1
~30

Find a Location

Closest Location:Texas Oncology PA (Austin)· Austin, TX· 518 miles

Who is running the clinical trial?

Processa PharmaceuticalsLead Sponsor
9 Previous Clinical Trials
289 Total Patients Enrolled
~60 spots leftby Sep 2026
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