Summary

for people ages 18 years and up (full criteria)
at San Francisco, California and other locations
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 Camptothecin Immunoconjugates 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

  • UCSF Helen Diller Family Comprehensive Cancer Center accepting new patients
    San Francisco California 94115 United States
  • HonorHealth Research Institute accepting new patients
    Avondale Arizona 85392 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