Last updated on June 2020

Study of IMMU-132 in HR+/HER2- MBC (TROPICS-02)


Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions: Metastatic Breast Cancer
  • Age: Between 18 - 100 Years
  • Gender: Male or Female

Inclusion Criteria:

  • Female or male subjects aged 18 years at the time of signing the informed consent form
  • Documented evidence of hormone receptor-positive HER2-negative (HR+/HER2-) MBC confirmed
  • Refractory to or relapsed after at least 2, and no more than 4, prior systemic chemotherapy regimens for MBC including:
  • At least 1 prior anticancer hormonal treatment.
  • At least 1 cyclin-dependent kinase inhibitor 4/6 in the metastatic setting.
  • Eligible for one of the chemotherapy options listed in the TPC arm
  • Documented disease progression after the most recent therapy
  • Adequate bone marrow function (hemoglobin > 9 g/dL, ANC > 1,500 per mm3, platelets > 100,000 per mm3).
  • Adequate renal function: calculated creatinine clearance 30 mL/minute according to the Cockcroft and Gault formula
  • Adequate hepatic function (bilirubin 1.5 IULN, AST and ALT 2.5 x IULN or 5.0 x IULN)
  • Females must not be lactating or pregnant at Screening or Baseline (as documented by a negative beta human chorionic gonadotropin [-hCG]

Exclusion Criteria:

  • Previous treatment with Topoisomerase 1 Inhibitors as a free form or as other formulations
  • History of significant cardiovascular disease or clinically significant ECG abnormality
  • Patients with Gilbert's disease.
  • Active infection requiring intravenous antibiotic use
  • Patients with a history of an anaphylactic reaction to irinotecan.
  • Other concurrent medical or psychiatric conditions that, in the Investigator's opinion, may be likely to confound study interpretation or prevent completion of study procedures and follow-up examinations.
  • Locally advanced MBC (stage IIIc) in subjects who are candidates for curative intent therapy at the time of study enrollment

Recruitment Status: Open


Brief Description Eligibility Contact Research Team


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