Dalpiciclib, Anti-HER2 Therapy, and Endocrine Therapy for Hormone-Receptor-Positive, HER2-Positive Metastatic Breast Cancer

Recruiting now · Phase 2

Conditions studied: Advanced/Metastatic Breast Cancer, HER2-Positive Metastatic Breast Cancer

In brief

Efficacy and Safety of Dalpiciclib Combined with Anti-HER2 Targeted Therapy and Endocrine Therapy as First-line Maintenance Treatment for Patients with Recurrent or Metastatic Hormone-Receptor-Positive, HER2-positive Breast Cancer.

Key facts

Study ID

NCT07610720

Run by

Sun Yat-sen University

People needed

57

Starts

2026-06-01

Expected to finish

2029-11-01

Last updated by the study team

2026-05-28

Who can join

Age: 18 and older, up to 75. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Females aged 18 to 75 years with pathologically confirmed metastatic or locally advanced unresectable breast cancer.
• Hormone receptor (HR)-positive and HER2-positive.
• Patients with no evidence of disease progression (including CR, PR, or SD)after 4-8 cycles of first-line systemic anti-tumor therapy.
• ECOG Performance Status: 0-1.

You may not qualify if…

• Symptomatic active brain metastases or extensive leptomeningeal metastases.
• History of Grade 3 or 4 allergic reaction related to the study drugs.
• Currently receiving other anti-tumor therapies.

Where it is running

• Sun yat-Sen University Cancer Center, Guangzhou, Yuexiu District — Guangdong, GUANGZHOU, China (enrolling)

Full record on ClinicalTrials.gov

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