Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UC Irvine UCLA UCSD UCSF
Dates
study started
estimated completion

Description

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.

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

Details

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

Keywords

Metastatic Breast Cancer 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 Breast Neoplasms Gemcitabine Capecitabine Vinorelbine Eribulin

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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]

You CAN'T join if...

  • 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

Locations

  • University of California, San Diego Moores Cancer Center accepting new patients
    La Jolla California 92093 United States
  • UCLA Department of Medicine - Hematology/Oncology accepting new patients
    Los Angeles California 90095 United States
  • University of California, Irvine Medical Center-Chao Family Comprehensive Cancer Center accepting new patients
    Orange California 92868 United States
  • UCSF Helen Diller Family Comprehensive Cancer Center accepting new patients
    San Francisco California 94115 United States
  • Los Angeles Hematology Oncology Medical Group in progress, not accepting new patients
    Los Angeles California 90017 United States
  • Southern California Permanente Medical Group accepting new patients
    San Diego California 92120 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Immunomedics, Inc.
ID
NCT03901339
Phase
Phase 3
Study Type
Interventional
Last Updated