West Cancer Center

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

Site Link

03901339

Malignancy

Breast, ER positive breast cancer, MBC, PR positive breast cancer, HER2 negative breast cancer

Stage

Stage 4

Disease Setting

Metastatic/Palliative

Line Of Therapy

3rd Line or greater

Investigational Agent

Sacituzumab govitecan

Drug Class

ADC for Trop-2

Lee Schwartzberg, MD

Sponsor

Immunomedics, Inc

Phase

Phase 3

Status

Closed to Accrual

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