Phase 1b Study of Pegylated Liposomal Doxorubicin and Pembrolizumab in Endocrine-resistant Breast Cancer
Status:
Recruiting
Trial end date:
2021-06-15
Target enrollment:
Participant gender:
Summary
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) and pembrolizumab-based in endocrine-resistant breast cancer (ERBC)
patients.
Up to 15 female patients, ages 18 and above, with pathological diagnosis of breast cancer,
estrogen receptor (ER) positive, human epidermal growth factor receptor 2 (HER2-) negative
subtype, stage III non-operable, or stage IV disease, who have received at least two lines of
hormonal therapy, one of which included aromatase inhibitors will be eligible for enrollment
to this single arm study.