NCT07179939View on ClinicalTrials.gov

Maintenance Therapy in HER2-Positive Unresectable Locally Recurrent or Metastatic Breast Cancer: A Phase II Study

PHASE2Not yet recruitingINTERVENTIONAL
Enrollment

288

Participants

Timeline

Start Date

September 10, 2025

Primary Completion Date

December 30, 2030

Study Completion Date

December 30, 2031

Conditions
HER2-positive Breast Cancer
Interventions
DRUG

Trastuzumab rezetecan

Trastuzumab rezetecan is a lyophilized powder for injection intravenously. Administered according to label.

DRUG

Pyrotinib

320 mg/d, q.d., p.o. A course of treatment need 21 days.

DRUG

Dalpiciclib

125 mg/d, q.d., p.o. day 1-21, every 28 days.

DRUG

Trastuzumab

Administered according to label.

DRUG

ET: Letrozole/ Anastrozole/ Exemestane/ Fulvestrant/ Leuprorelin/ Goserelin.

Administered according to label.

Trial Locations (1)

Unknown

Fudan University, Shanghai

All Listed Sponsors
collaborator

Jiangsu HengRui Medicine Co., Ltd.

INDUSTRY

collaborator

Chinese PLA General Hospital

OTHER

lead

Fudan University

OTHER