BREAST: METASTATIC: ER/PR+: 3rd Line or later: Sacituzumab: IMMU-132-09

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

Title
Immunomedics IMMU-132-09 (Breast HR+)
Study 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

Site Link
Malignancy
Breast, ER positive breast cancer, MBC, PR positive breast cancer, HER2 negative breast cancer
Stage
Disease Setting
Metastatic/Palliative
Line Of Therapy
3rd Line or greater
Investigational Agent
Sacituzumab govitecan
Drug Class
ADC for Trop-2
PI
Lee Schwartzberg, MD
Sponsor
Immunomedics, Inc
Phase
Status
Key Eligibility Criteria
Key Eligibility Criteria Details
  • Hormone receptor positive, HER2 negative metastatic breast cancer
  • Refractory to or relapsed after at least 2, and no more than 4, prior systemic therapies including;
    • At least 1 prior anticancer hormonal treatment
    • At least 1 CDK4/6 in the metastatic settting
  • Eligible to receive at least 1 of the following chemotherapies; eribulin, capecitabine, gemcitabine, vinorelbine
  • Disease progression after most recent therapy
  • No potential therapy available with curative intent (e.g. surgery)
  • No prior Topo1 inhibitors
Objective
  • Primary- PFS, ORR
  • Secondary- OS, DoR
Assessment Frequency
_
Assessment Frequency 2
_



Assessment Frequency Link
Path
ER/PR +, HER2-
Dosing Frequency
Control Agents
Study Protocol
<p>S:\\Research\\Protocols\\Immunomedics IMMU-132-09\\Protocols\\Current Protocol</p>
Randomized
Yes
X