This is an open-label, non-randomized, single-institution, single arm Phase II study conducted using a TOP design with 1 interim futility look at 10 patients (50% of enrollment). The overall objective is to determine the efficacy of weekly low dose doxorubicin. We will estimate the progression-free survival rate at 12 weeks (PFS12w) of doxorubicin in comparison to the historical PFS12w with standard dose doxorubicin monotherapy, calculated as the mean from two large, randomized Phase 3 clinical trials (21, 22)

Who can Participate

-Have a histological diagnosis of advanced or metastatic soft tissue leiomyosarcoma (LMS) (by local pathology review), not curable by surgery, for which treatment with weekly doxorubicin is deemed appropriate by the investigator. -Have received 0 to 4 prior systemic therapies for metastatic sarcoma and NO prior anthracyclines. Re-treatment with the same drug or regimen after interruption (i.e. chemotherapy holiday) is not considered a new line of treatment, and those patients are eligible.

Study ID

More information available at ClinicalTrials.gov: NCT07125183