Actively Recruiting
A Phase 2, Open-Label Study of PCS6422 With Capecitabine in Patients With Advanced or Metastatic Breast Cancer
Led by Processa Pharmaceuticals · Updated on 2025-06-19
90
Participants Needed
13
Research Sites
4 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the combination of PCS6422 with capecitabine compared to capecitabine alone in patients with advanced or metastatic breast cancer who cannot use anthracycline-, taxane-based, or other available therapies such as PD-1 or PARP inhibitors. This adaptive Phase 2, open-label, randomized, multi-center study aims to assess the efficacy and safety of adding PCS6422 to capecitabine in this patient population who have already received chemotherapy in the metastatic setting. Participants are randomly assigned to one of three groups: two different dosing regimens of PCS6422 combined with capecitabine or the standard dose of capecitabine alone. PCS6422 is given as a fixed single dose alongside capecitabine administered twice daily over seven days, with capecitabine doses varying between study arms from 150 mg to 450 mg twice daily. The study includes a treatment period followed by assessments up to 24 weeks after the end of treatment. During the study, participants will have regular imaging to measure tumor response according to RECIST 1.1 criteria, laboratory tests to monitor blood counts and organ function, and evaluations of adverse events over an average of eight months of treatment. Researchers will track outcomes such as objective response rate, disease control rate, duration and time to response, and progression-free survival. The trial involves ongoing safety monitoring and assessments throughout the treatment and follow-up periods.
CONDITIONS
Brief Title
A Phase 2 Study of PCS6422 With Capecitabine in Patients With Advanced or Metastatic Breast Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged 18 years or older at screening
- Histologically confirmed unresectable breast cancer, including triple-negative or hormone receptor positive, HER2 negative advanced or metastatic breast cancer
- Measurable disease per RECIST 1.1 by imaging within 28 days prior to first treatment
- Not suitable for other therapies such as taxanes or anthracycline-containing regimens
- Life expectancy of at least 24 weeks
- Eastern Cooperative Oncology Group performance status of 0 or 1
- Adequate bone marrow, liver, and kidney function based on specified laboratory tests within 7 days before first treatment
You will not qualify if you...
- Received treatment for advanced or metastatic breast cancer within 21 days or 5 drug half-lives prior to randomization
- Currently on hormone replacement therapy unless stopped at least 21 days before randomization
- Received intravenous or oral 5-FU or related drugs within 4 weeks before first treatment
- Received DPD inhibitor within 4 weeks before first treatment
- Have genetic DPYD variants causing severely reduced DPD enzyme activity
- History or presence of significant heart conditions including abnormal ECG, prolonged QTc, arrhythmias, congenital long QT syndrome, recent cardiac events or surgery within 12 months, or congestive heart failure
- Pregnant or breastfeeding
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 8 months
Participants receive PCS6422 combined with capecitabine or capecitabine alone as treatment for advanced or metastatic breast cancer.
Visits every 12 weeks during treatment
Duration - Up to 24 weeks post end of treatment
Participants are monitored for up to 24 weeks after treatment ends to evaluate treatment response and safety.
Approximately 2 to 3 visits post treatment
Trial Site Locations
Total: 13 locations
1
Arizona Oncology Associates
Tucson, Arizona, United States, 85711
Actively Recruiting
2
Valkyrie Clinical Trials
Los Angeles, California, United States, 90067
Actively Recruiting
3
FOMAT Medical Research
Oxnard, California, United States, 93030
Actively Recruiting
4
AP Medical Research
Miami, Florida, United States, 33165
Actively Recruiting
5
Moffitt Cancer Center
Tampa, Florida, United States, 33612
Actively Recruiting
6
Northwest Cancer Center
Dyer, Indiana, United States, 46311
Actively Recruiting
7
University of Maryland Medical Center (UMMC)
Baltimore, Maryland, United States, 21201
Actively Recruiting
8
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, United States, 08901
Actively Recruiting
9
Clinical Research Alliance
Westbury, New York, United States, 11590
Actively Recruiting
10
Gabrail Cancer Center Research
Canton, Ohio, United States, 44718
Actively Recruiting
11
SCRI Oncology Partners
Nashville, Tennessee, United States, 37203
Actively Recruiting
12
Texas Oncology PA (Austin)
Austin, Texas, United States, 78731
Actively Recruiting
13
Texas Oncology PA (San Antonio)
San Antonio, Texas, United States, 78240
Actively Recruiting
Research Team
S
Sian Bigora, PharmD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here