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

RECRUITINGPhase 2Sponsored by Sun Yat-sen University
Actively Recruiting
PhasePhase 2
SponsorSun Yat-sen University
Started2026-06-01
Est. completion2028-11-01
Eligibility
Age18 Years – 75 Years
SexFEMALE
Healthy vol.Accepted

Summary

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.

Eligibility

Age: 18 Years – 75 YearsSex: FEMALEHealthy volunteers accepted
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.

Conditions4

Advanced Metastatic Breast CancerBreast CancerCancerHER2-positive Metastatic Breast Cancer

Interventions5

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Trial data from ClinicalTrials.gov. Trial status and eligibility can change — verify directly with the study contact or on ClinicalTrials.gov.

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