Clinical Trials /

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

NCT03901339

Description:

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.

Related Conditions:
  • Breast Carcinoma
Recruiting Status:

Recruiting

Phase:

Phase 3

Trial Eligibility

Document

Title

  • Brief Title: Study of IMMU-132 in HR+/HER2- MBC (TROPICS-02)
  • Official Title: 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

Clinical Trial IDs

  • ORG STUDY ID: IMMU-132-09
  • NCT ID: NCT03901339

Conditions

  • Metastatic Breast Cancer

Interventions

DrugSynonymsArms
Sacituzumab GovitecanIMMU-132Sacituzumab Govitecan
Eribulineribulin mesylate, HalavenTPC Comparator
CapecitabineXelodaTPC Comparator
GemcitabineGemzarTPC Comparator
VinorelbineNavelbineTPC Comparator

Purpose

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.

Detailed Description

      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
    

Trial Arms

NameTypeDescriptionInterventions
Sacituzumab GovitecanExperimentalSacituzumab Govitecan 10 mg/kg via IV injection administered on Day 1 and Day 8 (21-day cycle)
  • Sacituzumab Govitecan
TPC ComparatorActive ComparatorTPC determined prior to randomization. Per NCCN guidelines (with dose modifications for if toxic) Eribulin; Capecitabine; Gemcitabine; Vinorelbine
  • Eribulin
  • Capecitabine
  • Gemcitabine
  • Vinorelbine

Eligibility Criteria

        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
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Progression-free survival (PFS)
Time Frame:within approximately 3 years
Safety Issue:
Description:PFS based on Investigator Assessment is defined as the time from randomization to the first clinical observation of disease progression or death.

Secondary Outcome Measures

Measure:Overall Survival (OS)
Time Frame:within approximately 4 years
Safety Issue:
Description:OS is defined as the time from randomization to death
Measure:Duration of Response (DoR)
Time Frame:within approximately 3 years
Safety Issue:
Description:DoR is defined as the time from the first documented objective response (CR or PR) to the first documented disease progression or death

Details

Phase:Phase 3
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Immunomedics, Inc.

Trial Keywords

  • Sacituzumab Govitecan
  • IMMU-132
  • TPC
  • estrogen receptor
  • progesterone receptor
  • hormonal receptor
  • Anti-TROP2
  • Unresectable or Metastatic Breast Cancer
  • Human epidermal growth factor receptor 2 (HER2) Negative
  • ADC
  • Antibody Drug Conjugate

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