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

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ClinicalTrials.gov Identifier: NCT03901339
Recruitment Status : Recruiting
First Posted : April 3, 2019
Last Update Posted : March 5, 2021
Sponsor:
Information provided by (Responsible Party):
Immunomedics, Inc.

Tracking Information
First Submitted Date  ICMJE March 26, 2019
First Posted Date  ICMJE April 3, 2019
Last Update Posted Date March 5, 2021
Actual Study Start Date  ICMJE May 30, 2019
Estimated Primary Completion Date November 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 1, 2019)
  • Progression-free survival (PFS) [ Time Frame: within approximately 3 years ]
    PFS based on Investigator Assessment is defined as the time from randomization to the first clinical observation of disease progression or death.
  • Objective (overall) response rate (ORR) [ Time Frame: within approximately 3 years ]
    ORR is defined as the percentage of participants who achieve objective CR or PR, confirmed by second assessment
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 1, 2019)
  • Overall Survival (OS) [ Time Frame: within approximately 4 years ]
    OS is defined as the time from randomization to death
  • Duration of Response (DoR) [ Time Frame: within approximately 3 years ]
    DoR is defined as the time from the first documented objective response (CR or PR) to the first documented disease progression or death
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of IMMU-132 in HR+/HER2- MBC (TROPICS-02)
Official Title  ICMJE 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
Brief Summary 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
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Metastatic Breast Cancer
Intervention  ICMJE
  • Drug: Sacituzumab Govitecan
    Sacituzumab Govitecan (IMMU-132) is an antibody drug conjugate composed of the humanized monoclonal antibody, which binds to trophoblastic cell-surface antigen-2 (Trop-2); SN-38, a topoisomerase I inhibitor; and CL2A.
    Other Name: IMMU-132
  • Drug: Eribulin
    Eribulin (per NCCN guidelines)
    Other Names:
    • eribulin mesylate
    • Halaven
  • Drug: Capecitabine
    Capecitabine (per NCCN guidelines)
    Other Name: Xeloda
  • Drug: Gemcitabine
    Gemcitabine (per NCCN guidelines)
    Other Name: Gemzar
  • Drug: Vinorelbine
    Vinorelbine (per NCCN guidelines)
    Other Name: Navelbine
Study Arms  ICMJE
  • Experimental: Sacituzumab Govitecan
    Sacituzumab Govitecan 10 mg/kg via IV injection administered on Day 1 and Day 8 (21-day cycle)
    Intervention: Drug: Sacituzumab Govitecan
  • Active Comparator: TPC Comparator

    TPC determined prior to randomization.

    Per NCCN guidelines (with dose modifications for if toxic) Eribulin; Capecitabine; Gemcitabine; Vinorelbine

    Interventions:
    • Drug: Eribulin
    • Drug: Capecitabine
    • Drug: Gemcitabine
    • Drug: Vinorelbine
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: April 1, 2019)		 400
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE May 2023
Estimated Primary Completion Date November 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Immunomedics Medical Information 888.983.4668 medinfo@immunomedics.com
Listed Location Countries  ICMJE Belgium,   Canada,   France,   Germany,   Italy,   Netherlands,   Spain,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03901339
Other Study ID Numbers  ICMJE IMMU-132-09
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Immunomedics, Inc.
Study Sponsor  ICMJE Immunomedics, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Immunomedics Medical Director Immunomedics, Inc.
PRS Account Immunomedics, Inc.
Verification Date March 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP