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

  • Interventional
  • Not Recruiting
  • NCT03901339
Eligibility Details Visit Clinicaltrials.gov

Phase 3 Study of Sacituzumab Govitecan vs Physician's Choice in Subjects With Hormonal Receptor-Positive Human Epidermal Growth Factor Receptor 2 Negative Metastatic Breast Cancer Who Have Failed at Least 2 Prior Chemotherapy Regimens

This is an open-label, randomized, multicenter Phase 3 study to compare the efficacy and safety of Sacituzumab Govitecan versus TPC in subjects with metastatic or locally recurrent inoperable HR+/HER2- MBC, after failure of at least 2, and no more than 4, prior chemotherapy regimens for metastatic disease.

Approximately 400 eligible subjects will be randomized to one of the following 2 treatment arms:

     Investigational Arm:

     Sacituzumab Govitecan 10 mg/kg via IV injection administered on Day 1 and Day 8 (21-day cycle).

     Control Arm:

     Recommended doses and schedules as per NCCN guidelines (with dose modifications if too toxic).

     Eribulin; Capecitabine; Gemcitabine; Vinorelbine

Gender
All

Age Group
18 Years and up

Accepting Healthy Volunteers?
No

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 [ß-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

At a Glance

National Government IDNCT03901339

IRB#IRB19-0979

Lead SponsorGilead Sciences

Lead PhysicianRita Nanda

Collaborator(s)N/A

EligibilityAll
18 Years and up
Not Recruiting