MedTrace Logo

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

NCT07163481 · Status: NOT_YET_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2025-09-16

No results posted yet for this study

Summary

SoGreat is an open-label, single-arm, modular, two-stage, Phase Ib/II study. SoGreat (Part 1) is an open-label, modular, Phase Ib study.

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

Sponsors & Collaborators

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-10-31
Primary Completion
2026-12-31
Completion
2026-12-31

Countries

  • China

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07163481 on ClinicalTrials.gov