Sacituzumab Govitecan in RR Triple-Negative Breast Cancer

An International, Multi-Center, Open-Label, Randomized, Phase III Trial of Sacituzumab Govitecan versus Treatment of Physician Choice in Patients with Metastatic Triple-Negative Breast Cancer Who Received at Least Two Prior Treatments

January 17, 2018

  • Clinical Trial Information

    Trial Contact: Jobson, Gillian S

    Trial Phone: 321.841.2285

  • IRB No: 17.100.08

    Protocol Abbrev: IMMU-132-05

    Principal Investigator: Rebecca L. Moroose, MD

    Sub Investigators: Cuesta, Ana MD; Baidas, Said MD; Rostorfer, Regan MD; Shah, Nikita MD

    Phase: Drug: Phase III

    Age Group: Adult

    Secondary Protocol No: IMMU-132-05

    Treatment: Medication

    Applicable Disease Sites: Breast Cancer

    Therapies Involved: Sacitzumab govitecan or treatment of physician choice (TPC) ID: NCT02574455

  • Objective

    The primary objective of this study is to compare the efficacy of sacituzumab govitecan to the treatment of physician’s choice (TPC) as measured by progression-free survival (PFS) in patients with metastatic TNBC previously treated with at least two systemic chemotherapy regimens.

  • Key Eligibility

    •   Female or male patients, >18 years of age, must be able to give signed, written informed consent.
    •   Have histological or cytological confirmation of TNBC as determined by local institution according to ASCO/CAP criteria, with metastatic disease documented by CT or MRI imaging, and currently have measurable disease by CT or MRI.
    •   Patients with brain metastases are eligible only if treated and stable by MRI for at least 4 weeks priot to randomization provided they are off high-dose steroids (>20 mg prednisone or equivalent) for at least 2 weeks.
    •   They must be refractory to, or relapsed after, at least two prior standard-of-care chemotherapy regimens for unresectable, locally advanced or metastatic breast cancer and these regimens will qualify regardless of triple-negative status at the time they were given.
    •   All patients must have been previously treated with taxane regardless of disease stage (adjuvant, neoadjuvant or advanced) when it was given.
    •   Patients must have an ECOG performance score of 0 or 1, adequate hematology without ongoing transfusion support (hemoglobin > 9 g/dL, ANC > 1,500 per mm3, platelets > 100,000 per mm3), adequate renal and hepatic function (creatinine clearance of > 60 ml/min, may be calculated using Cockcroft-Gault equation), bilirubin ≤ 1.5 IULN, AST and ALT ≤ 3.0 x IULN or ≤ 5 x IULN if known liver metastases),
    •   Least 2 weeks beyond prior anti-cancer treatment (chemotherapy, radiotherapy and/or major surgery) or at least 3 weeks beyond prior antibody treatment for cancer and, with exception of alopecia and neuropathy (≤ Grade 2), recovered from all acute toxicities to Grade 1 or less.