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Anti-metabolites

PCS6422 + Capecitabine for Breast Cancer

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

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

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.
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.
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.

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.

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 2019 Phase 2 trial • 10 Patients • NCT02000882
60%
Nausea
50%
Vomiting
50%
Fatigue
50%
Anorexia
50%
Hypokalemia
40%
Urinary tract infection
40%
Diarrhea
40%
Mucositis oral
30%
Insomnia
30%
Palmar-plantar erythrodysesthesia
30%
Rash
20%
AST increased
20%
Seizure
20%
Blurred vision
20%
Falling down
20%
Bilirubin increased
20%
ALT increased
20%
Dehyrdration
20%
Constipation
20%
Hyponatremia
20%
Headache
10%
Facial swelling
10%
Hypertension
10%
Disorder ear
10%
Epilepsy
10%
Knee Pain
10%
Rash erythematous
10%
Anemia
10%
Hypovolemia
10%
Leukopenia
10%
Neutropenia
10%
Disorder eye
10%
Eye floaters
10%
Vision abnormal
10%
Stomatitis
10%
Hand-foot syndrome
10%
Legs restless
10%
Taste alteration
10%
Allergic reaction
10%
Thrush
10%
Creatinine serum increased
10%
Amylase increased
10%
Growth accelerated
10%
Hyperglycemia
10%
Dyspnea
10%
Epistaxis
10%
Colitis
10%
Dysphagia
10%
Weakness generalized
10%
Visual disturbance
10%
Abdominal Pain
10%
Canker sore oral
10%
Cramp abdominal
10%
Dry mouth
10%
Gastritis
10%
Hemorrhoids
10%
Pancreatitis
10%
Spasm oropharyngeal
10%
Hypocalcemia
10%
Lipase increased
10%
Dizziness
10%
Edema cerebral
10%
Neuropathy
10%
Numbness
10%
Somnolence
10%
Tremor
10%
Agitation
10%
Depression
10%
Emotional lability
10%
Incontinence urinary
10%
Renal function abnormal
10%
Potassium deficiency
10%
Muscle weakness
10%
Dysgeusia
100%
80%
60%
40%
20%
0%
Study treatment Arm
BKM120 Plus Capecitabine

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

Find a Location

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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