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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 : September 29, 2020
Sponsor:
Information provided by (Responsible Party):
Immunomedics, Inc.

Study Description
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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.

Condition or disease Intervention/treatment Phase
Metastatic Breast Cancer Drug: Sacituzumab Govitecan Drug: Eribulin Drug: Capecitabine Drug: Gemcitabine Drug: Vinorelbine Phase 3

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : May 30, 2019
Estimated Primary Completion Date : November 2021
Estimated Study Completion Date : May 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Sacituzumab Govitecan
Sacituzumab Govitecan 10 mg/kg via IV injection administered on Day 1 and Day 8 (21-day cycle)
 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
Active Comparator: TPC Comparator

TPC determined prior to randomization.

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

 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


Outcome Measures
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Primary Outcome Measures :
  1. 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.

  2. 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


Secondary Outcome Measures :
  1. Overall Survival (OS) [ Time Frame: within approximately 4 years ]
    OS is defined as the time from randomization to death

  2. 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


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03901339


Contacts
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Contact: Immunomedics Medical Information 888.983.4668 medinfo@immunomedics.com

Locations
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Sponsors and Collaborators
Immunomedics, Inc.
Investigators
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Study Director: Immunomedics Medical Director Immunomedics, Inc.
More Information
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Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Immunomedics, Inc.
ClinicalTrials.gov Identifier: NCT03901339    
Other Study ID Numbers: IMMU-132-09
First Posted: April 3, 2019    Key Record Dates
Last Update Posted: September 29, 2020
Last Verified: September 2020

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Immunomedics, Inc.:
Sacituzumab Govitecan
IMMU-132
Unresectable or Metastatic Breast Cancer
TPC
estrogen receptor
progesterone receptor
 hormonal receptor
Anti-TROP2
Human epidermal growth factor receptor 2 (HER2) Negative
ADC
Antibody Drug Conjugate
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Gemcitabine
Capecitabine
Vinorelbine
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
 Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents, Phytogenic
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators