Pembrolizumab and Oral Metronomic Cyclophosphamide in Patients With Chest Wall Breast Cancer

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" b

Trial Details

NCT ID
NCT03971045
Phase
PHASE2
Sponsor
European Institute of Oncology
Status
RECRUITING
Cancer Type
Breast Cancer
Interventions
  • Pembrolizumab
Locations (sample)
  • Milan, Italy|45.46427,9.18951

Key Eligibility Criteria

  • Histologically proven, PDL1 (≥1%) positive and/or tumor infiltrating lymphocytes (TILs) positive (≥1%), locally advanced "chest wall" breast cancer…
  • Patients must have tissue accessible for serial biopsies;
  • Expected survival of \> 3 months;
  • Be willing and able to provide written informed consent/assent for the trial. The subject may also provide consent/assent for Future Biomedical Res…

For full eligibility, visit ClinicalTrials.gov.

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