A Trial to Evaluate Sacituzumab Govitecan in Combination With Endocrine Therapy in Patients With HR-positive, HER2-negative Metastatic Breast Cancer Progressed on CDK4/6 Inhibitors

PHASE1Not yet recruitingINTERVENTIONAL
Enrollment

12

Participants

Timeline

Start Date

October 31, 2025

Primary Completion Date

December 31, 2026

Study Completion Date

December 31, 2026

Conditions
Stage IV (Metastatic) Breast Cancer
Interventions
DRUG

Sacituzumab Govitecan + Fulvestrant

Sacituzumab Govitecan 10 mg/kg intravenously on Days 1 and 8 of 21-day cycles Combined with Fulvestrant 500 mg intramuscularly into the buttock on Day 1 of 28-day cycles and Cycle 1 Day 15

DRUG

Sacituzumab Govitecan + Anastrozole / Exemestane

Sacituzumab Govitecan 10 mg/kg intravenously on Days 1 and 8 of 21-day cycles Combined with One of the Two Investigator's choice of aromatase inhibitors (ICAI), orally, once daily: Anastrozole 1 mg Exemestane 25 mg

Trial Locations (1)

410000

Hunan Cancer Hospital, Changsha

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Gilead Sciences

INDUSTRY

lead

Hunan Cancer Hospital

OTHER