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New treatment option for Breast Cancer
Official title A Phase 2 Study of PCS6422 With Capecitabine in Patients With Advanced or Metastatic Breast Cancer
ClinicalTrials.gov ID: NCT06568692
What this study is testing
What is PCS6422 and capecitabine?
PCS6422 and capecitabine is an investigational medicine, being studied as a potential treatment for breast cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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
You likely can't join if
- 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:
See the full eligibility criteria
- 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
- 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...
- 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:
- 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...
- Class II per the New York Heart Association, or history of myocarditis
- Is pregnant or breastfeeding
The study team makes the final eligibility decision.
Where it's taking place
- Tucson, Arizona, United States
- Los Angeles, California, United States
- Oxnard, California, United States
- Miami, Florida, United States
- Tampa, Florida, United States
- Dyer, Indiana, United States
- Baltimore, Maryland, United States
- New Brunswick, New Jersey, United States
- Westbury, New York, United States
- Canton, Ohio, United States
- Nashville, Tennessee, United States
- Austin, Texas, United States
- San Antonio, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Tucson, Arizona, United States; Los Angeles, California, United States; Oxnard, California, United States; Miami, Florida, United States; Tampa, Florida, United States; Dyer, Indiana, United States and 7 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.