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

NCT07179939 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 288

Last updated 2025-09-18

No results posted yet for this study

Summary

This is a phase II trial exploring the maintenance therapy with trastuzumab combined with pyrotinib or dalpiciclib and endocrine therapy in HER2-positive advanced breast cancer based on different hormone receptor (HR) statuses following trastuzumab rezetecan (T-DXh, SHR-A1811) as induction treatment for HER2-positive unresectable locally recurrent or metastatic breast cancer (MBC) patients.

Conditions

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.

Sponsors & Collaborators

  • Jiangsu HengRui Medicine Co., Ltd.

    collaborator INDUSTRY

  • Chinese PLA General Hospital

    collaborator OTHER

  • Fudan University

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-09-10
Primary Completion
2030-12-30
Completion
2031-12-30
FDA Drug
Yes

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs
Diseases

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 NCT07179939 on ClinicalTrials.gov