Sacituzumab Govitecan-hziy

Drug

Drug Profile

Sacituzumab govitecan-hziy is marketed as TRODELVY, a Trop-2-directed antibody-drug conjugate used in pretreated unresectable locally advanced or metastatic triple-negative breast cancer and HR-positive/HER2-negative metastatic breast cancer. It delivers the topoisomerase I inhibitor SN-38 to Trop-2-expressing tumor cells after internalization. U.S. initial approval was in 2020.

Drug Class
Trop-2-directed antibody and topoisomerase inhibitor conjugate (ADC)
Approval Status
FDA approved (Initial U.S. Approval: 2020)
Mechanism of Action
Trop-2-directed ADC that is internalized in Trop-2-expressing cells and releases SN-38, which inhibits topoisomerase I and causes DNA damage leading to apoptosis.
Brand Names
  • TRODELVY
Indications
  • \Unresectable locally advanced or metastatic triple-negative breast cancer after at least two prior systemic therapies (one for metastatic disease)\
  • \Unresectable locally advanced or metastatic HR-positive, HER2-negative breast cancer after endocrine-based therapy and at least two additional systemic therapies in the metastatic setting\

Related News

Phase 3 Breast Cancer Trial Data Highlights from Q1 2026

Multiple phase 3 breast cancer trials reported significant findings in early 2026, including positive results for novel therapies across different subtypes. Key data includes progression-free survival benefits for palbociclib in HR-positive, HER2-positive advanced breast cancer and investigations of antibody-drug conjugates and combination therapies. Full trial findings are expected to be presented at upcoming medical meetings.

Related Clinical Trials

NCT ID Title Status Phase
NCT06486441

Study of Sacituzumab Govitecan Versus Treatment of Physician's Choice in Participants With Endometrial Cancer After Platinum-Based Chemotherapy and Immunotherapy (ASCENT-GYN-01/GOG-3104/ENGOT-en26)

ACTIVE_NOT_RECRUITING PHASE3
NCT06477419

A Study of Sacituzumab Govitecan in People With Mesothelioma

RECRUITING PHASE2
NCT06248515

A Phase II Trial of Sacituzumab Govitecan in Patients With Advanced Thymic Epithelial Tumors

RECRUITING PHASE2
NCT05867251

Study of AVZO-021 in Patients With Advanced Solid Tumors

RECRUITING PHASE1/PHASE2
NCT05840211

Study of Sacituzumab Govitecan Versus Treatment of Physician's Choice in Patients With Hormone Receptor-positive/Human Epidermal Growth Factor Receptor 2 Negative (HR+/HER2-) Metastatic Breast Cancer Who Have Received Endocrine Therapy

ACTIVE_NOT_RECRUITING PHASE3
NCT05382299

Study of Sacituzumab Govitecan-hziy Versus Treatment of Physician's Choice in Patients With Previously Untreated Locally Advanced Inoperable or Metastatic Triple-Negative Breast Cancer

ACTIVE_NOT_RECRUITING PHASE3
NCT05382286

Study of Sacituzumab Govitecan-hziy and Pembrolizumab Versus Treatment of Physician's Choice and Pembrolizumab in Patients With Previously Untreated, Locally Advanced Inoperable or Metastatic Triple-Negative Breast Cancer

ACTIVE_NOT_RECRUITING PHASE3
NCT05119907

Study of Sacituzumab Govitecan in Patients With Solid Tumor

ACTIVE_NOT_RECRUITING PHASE2
NCT05113966

Trilaciclib in Patients Receiving Sacituzumab Govitecan-hziy for Triple Negative Breast Cancer

TERMINATED PHASE2
NCT05101096

Study of Sacituzumab Govitecan (SG) in Japanese Participants With Advanced Solid Tumors

ACTIVE_NOT_RECRUITING PHASE1/PHASE2