NCT07179939

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

A Multicenter, Open-Label, Phase II Trial of Exploring the Maintenance of Trastuzumab Plus Pyrotinib or Trastuzumab Plus Dalpiciclib and Endocrine Therapy Based on HR Status Following Trastuzumab Rezetecan as Induction Treatment for HER2 Positive Unresectable Locally Recurrent or Metastatic Breast Cancer

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 288 (estimated)
• Sponsor: Fudan University · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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

• HER2-positive Breast Cancer

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2025-09-10
• Primary completion: 2030-12-30
• Completion: 2031-12-30
• First posted: 2025-09-18
• Last updated: 2025-09-18

Locations

1 site across 1 country: China

Regulatory

• FDA-regulated drug study