Actively Recruiting
A Phase 2 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
104 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official 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 by imaging within 28 days before treatment start
- 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 at screening
- Adequate bone marrow, liver, and kidney function as shown by recent lab tests including hemoglobin \u22659 g/dL, creatinine clearance over 50 mL/min, neutrophil count \u22651.5 x10^9/L, platelet count \u2265100 x10^9/L, bilirubin <1.5 times upper limit of normal (ULN), liver enzymes <2.5 times ULN (or <5 times ULN if liver metastasis), and normal blood clotting tests unless on anticoagulants with therapeutic levels
You will not qualify if you...
- Received treatment for advanced or metastatic breast cancer within 21 days or 5 half-lives before 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 treatment start
- Received DPD inhibitors within 4 weeks before treatment start
- Have genetic variants causing absence or near absence of DPD enzyme activity
- History or presence of significant abnormal ECG results or prolonged QTc interval >480 msec
- History of serious heart rhythm problems or congenital long QT syndrome
- Significant cardiac disease or events such as recent heart attack, unstable angina, heart failure class II or higher, myocarditis, or recent heart surgery within 12 months
- Pregnant or breastfeeding
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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