Dalpiciclib with Anti-HER2 and Endocrine Therapy as Maintenance in HR+/HER2+ Metastatic Breast Cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This multicenter, single-arm, open-label study evaluates the safety and effectiveness of dalpiciclib combined with anti-HER2 therapy and endocrine therapy as maintenance treatment for patients with HR+/HER2+ metastatic breast cancer who completed induction therapy without progression. Eligible participants have completed 4–8 cycles of first-line therapy, are ECOG 0–1, and have no active brain metastases. The trial uses a dalpiciclib-containing regimen with trastuzumab, pertuzumab, pyrotinib, and endocrine therapy to see if progression-free survival can be extended. Prior data in HR+/HER2- disease suggest manageable safety and potential benefit for CDK4/6 inhibitors in similar settings, guiding this investigation.

Why it matters

Who can join: the full rules

Inclusion Criteria:

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

Exclusion Criteria:

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

Where it's running

• Sun yat-Sen University Cancer Center, Guangzhou, Yuexiu District
  Guangdong, Guangzhou, China Recruiting

Study contacts

• Study coordinator: Chen Doctor Chen, PhD / Doctorate
• Email: chenmt@sysucc.org.cn
• Phone: 02087341812

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.