Actively Recruiting
I-CURE-1: A Phase II Study of Pembrolizumab Combined with Carboplatin in Patients with Circulating Tumor Cells Positive HER2 Negative Metastatic Breast Cancer
Led by Northwestern University ยท Updated on 2021-05-03
100
Participants Needed
1
Research Sites
56 weeks
Total Duration
On this page
Sponsors
N
Northwestern University
Lead Sponsor
M
Merck Sharp & Dohme LLC
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the combination of pembrolizumab and carboplatin in patients with circulating tumor cells (CTC) positive, HER2 negative metastatic breast cancer who have previously been treated with anthracyclines and taxanes. This phase II study aims to assess whether adding pembrolizumab, an immune therapy drug that may help restore T-cell function, can improve progression-free survival (PFS) compared to chemotherapy alone. Previous evidence suggests that recurrent breast cancers may resist chemotherapy and be linked to weakened immune responses, making immune modulation a key area of investigation. Participants receive pembrolizumab through an intravenous infusion over 30 minutes on day 1, combined with carboplatin given intravenously over 30 to 60 minutes starting with the third treatment cycle. Each course repeats every 21 days for up to 24 months, provided there is no disease progression or unacceptable side effects. There is no placebo or control group in this single-arm study. During the study, patients will be monitored regularly with assessments every 9 weeks to evaluate progression-free survival and other measures such as overall survival, response rates, clinical benefit, immune-related tumor response, and time to new metastases. Correlative studies will measure biomarkers like PD-L1 expression and circulating tumor DNA. After treatment ends, follow-up visits occur within 30 days, then every 9 weeks for a year, and every 12 weeks thereafter, lasting up to 3 years in total.
CONDITIONS
Brief Title
Pembrolizumab and Carboplatin in Treating Patients With Circulating Tumor Cells Positive Metastatic Breast Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 years or older
- Diagnosed with hormone receptor negative, HER2 negative metastatic breast cancer (triple negative breast cancer) without prior chemotherapy for metastatic disease
- Confirmed HER2 negative status by standard testing according to guidelines
- Circulating tumor cell count of 5 or more
- Measurable disease based on RECIST 1.1 criteria
- Willing to provide archival tissue if available
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
- Adequate organ function and blood counts within defined limits
- Negative pregnancy test for women of childbearing potential and agreement to use contraception
- Ability to provide informed consent
You will not qualify if you...
- HER2 positive breast cancer
- Participation in another investigational study within 28 days prior to registration
- Immunodeficiency or recent immunosuppressive therapy within 7 days
- Active tuberculosis
- Allergy to pembrolizumab or its components
- Recent anti-cancer monoclonal antibody or chemotherapy within specified timeframes unless recovered
- Recent major surgery without adequate recovery
- Other malignancies requiring treatment in the last 5 years except certain skin or cervical cancers
- Active or unstable brain metastases or carcinomatous meningitis
- Active autoimmune disease requiring systemic treatment within 2 years
- Active pneumonitis or history of severe pneumonitis requiring steroids
- Active infection requiring systemic therapy
- Conditions or disorders interfering with study participation
- Psychiatric or substance abuse disorders interfering with cooperation
- Pregnancy or breastfeeding or planning to conceive during study period
- Prior therapy with anti-PD-1, anti-PD-L1, or anti-PD-L2 agents
- Known HIV infection
- Active hepatitis B or C infection
- Recent live vaccine within 30 days before starting study therapy except inactivated flu vaccine
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 - Up to 24 months
Participants receive pembrolizumab intravenously over 30 minutes on day 1 of each course. Starting with course 3, carboplatin is given intravenously over 30 to 60 minutes on day 1. Courses repeat every 21 days for up to 24 months unless the disease progresses or side effects become unacceptable.
Visits every 21 days for treatment administration
Duration - Up to 3 years
After treatment ends, participants are followed up to monitor overall survival, progression, and response. Follow-up visits occur within 30 days after treatment, then every 9 weeks for 1 year, and every 12 weeks thereafter.
Visits within 30 days post-treatment, then every 9 weeks for 1 year, then every 12 weeks
Trial Site Locations
Total: 1 location
1
Northwestern University
Chicago, Illinois, United States, 60611
Actively Recruiting
Research Team
S
Study Coordinator
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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