Actively Recruiting
Pembrolizumab and Oral Metronomic Cyclophosphamide in Patients With Chest Wall Breast Cancer
Led by European Institute of Oncology · Updated on 2024-11-19
46
Participants Needed
1
Research Sites
249 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a Phase II single center, open-label, non-randomized study in patients with locally recurrent, inoperable, and/or metastatic inflammatory breast cancer with lymphangitic spread to the chest wall. Patients will be treated with pembrolizumab administered as an intravenous infusion at 200 mg in 21-day treatment cycles and oral cyclophosphamide (CTX) 50 mg per day in metronomic administration as a 21 days cycle Forty-six patients will be required for the study. Key inclusion criteria are PDL1 (≥1%) positive and/or tumor infiltrating lymphocyte positive (≥1%) locally advanced "chest wall" breast cancer (with or without distant metastases), who have been treated with chemotherapy or radiation therapy may be eligible for this study. Patients with cutaneous metastases only (with or without evidence of primary tumor) are eligible for the study. Key exclusion criteria included prior anti PD1 or anti CTLA-4 or other immune pathway-targeted therapy. Patients with autoimmune diseases and/or receiving drugs who interfere with the immune system will not be eligible.
CONDITIONS
Official Title
Pembrolizumab and Oral Metronomic Cyclophosphamide in Patients With Chest Wall Breast Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically confirmed locally advanced chest wall breast cancer with PD-L1 65 1% and/or tumor infiltrating lymphocytes 65 1%, with or without distant metastases
- Prior treatment with chemotherapy or radiation therapy
- Patients with cutaneous metastases only are eligible
- Tissue accessible for serial biopsies
- Expected survival greater than 3 months
- Able and willing to provide written informed consent
- Age 18 years or older at consent
- Female or male with inflammatory breast cancer with lymphangitic spread to chest wall
- Tumor tissue provided for PD-L1 biomarker analysis from a recent biopsy
- Measurable metastatic disease based on immune-related RECIST criteria
- ECOG performance status of 0 or 1 within 10 days before treatment
- Female subjects of childbearing potential must agree to use contraception during study and 120 days after last dose
- Male subjects of childbearing potential must agree to use contraception during study and 120 days after last dose
- Negative pregnancy test within 72 hours before first dose for females of childbearing potential
- Hormone receptor-positive and/or HER2-positive breast cancer patients eligible if disease refractory to hormonal or anti-HER2 agents
- Adequate organ function confirmed within 10 days before treatment
You will not qualify if you...
- Participation in another investigational study or use of investigational therapy within 4 weeks before treatment
- Immunodeficiency or systemic steroid or immunosuppressive therapy within 7 days before treatment
- Active tuberculosis diagnosis
- Hypersensitivity to pembrolizumab or its components
- Prior anti-cancer monoclonal antibody therapy within 4 weeks before study or unresolved adverse events
- Chemotherapy, targeted therapy, or radiation therapy within 2 weeks before study or unresolved adverse events, except 64 Grade 2 neuropathy
- Inadequate recovery from major surgery before starting therapy
- Additional progressing malignancy requiring active treatment (except certain skin cancers and in situ cervical cancer)
- Active central nervous system metastases or carcinomatous meningitis
- Active autoimmune disease needing systemic treatment in past 2 years
- History or evidence of active non-infectious pneumonitis
- Active infection requiring systemic therapy
- Any condition or treatment that may interfere with trial participation or safety
- Psychiatric or substance abuse disorders interfering with cooperation
- Pregnancy, breastfeeding, or planning conception during study and 120 days after last dose
- Prior therapy with anti-PD-1, anti-PD-L1, or anti-PD-L2 agents
- Known HIV infection
- Active Hepatitis B or C infection
- Live vaccine received within 30 days before planned start of therapy (except inactivated seasonal flu vaccines)
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Istituto Europeo di Oncologia
Milan, Italy, 20141
Actively Recruiting
Research Team
G
Giuseppe Curigliano, MD PhD
CONTACT
B
Bruno Duso, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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