Phase 1b Study of Pegylated Liposomal Doxorubicin and Pembrolizumab in Endocrine-resistant Breast Cancer

Very few patients with endocrine-resistant, hormone-receptor positive metastatic breast cancer respond to single agent immunotherapy. Responses to chemotherapy are usually of short duration. Combining immunotherapy with chemotherapy that has minimal immunosuppressive effect, it may be possible to achieve higher response rates while keeping the immune-associated pattern of long durations of response. This will be a single-center phase 1b study to evaluate the tumor response and appropriate dose of a chemo-immunotherapy regime consisting of treatment with pegylated liposomal doxorubicin (PLD) a

Trial Details

NCT ID
NCT03591276
Phase
PHASE1 / PHASE2
Sponsor
Shaare Zedek Medical Center
Status
RECRUITING
Cancer Type
HER2 Positive Breast Cancer
Interventions
  • Chemotherapy Drugs, Cancer
Locations (sample)
  • Jerusalem, Israel|31.76904,35.21633

Key Eligibility Criteria

  • Have pathological diagnosis of breast cancer, ER positive (%ER+ cells≥1%, Allred score ≥3), Her2 negative subtype, locally advanced (stage III non-…
  • Have measurable disease on computed tomography (CT) or positron emission tomography-computed tomography (PET-CT) scan.
  • 2\. Be 18 years of age on day of signing informed consent. 3. Have measurable disease based on RECIST 1.1. 4. Have Eastern Cooperative Oncology Gro…
  • 7\. Have received at least two lines of hormonal therapy, one of which had included aromatase inhibitors.

For full eligibility, visit ClinicalTrials.gov.

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