|
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
View on ClinicalTrials.gov →
NCT07610720
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
Related trials
- A Randomised, Open-label, Multicentre Phase III Clinical Study to Evaluate the Efficacy and Safety of JS105 Combined With Dalpiciclib and Fulvestrant Compared With Dalpiciclib and Fulvestrant in Patients With PIK3CA-mutated, HR-positive, HER2-negative Recurrent or Metastatic Breast Cancer. — Risen (Suzhou) Pharma Tech Co., Ltd.
- Adebrelimab Combined With Dalpiciclib and Standard Endocrine Therapy for HR+/HER2 - Advanced Breast Cancer — Tongji Hospital
- Apatinib With CDK4/6 Inhibitor and Endocrine Therapy in HR+/ HER2- Advanced Breast Cancer — Fudan University
- Dalpiciclib Plus AI (Neoadjuvant Endocrine Therapy) Compared With Neoadjuvant Chemotherapy in Early Breast Cancer (EBC) — Hebei Medical University Fourth Hospital
- Dalpiciclib With or Without Entinostat and Letrozole in HR+/HER2- Early Breast Cancer — Hebei Medical University Fourth Hospital
- Dalpiciclib in HR+/HER2- ABC — RenJi Hospital
- Efficacy and Safety of Dalpiciclib With Endocrine Therapy as Adjuvant Treatment in HR+/ HER2- Early Breast Cancer — The First Affiliated Hospital with Nanjing Medical University
- Efficacy and Safety of Dalpiciclib in Hormone Receptor-positive Advanced Breast Cancer — Hebei Medical University Fourth Hospital
Browse More Trials
Trial data from ClinicalTrials.gov. Trial status and eligibility can change — verify directly with the study contact or on ClinicalTrials.gov.
This site does not provide medical advice. Always consult your doctor before considering enrollment in a clinical trial. Learn more on our About page.
Actively Recruiting
PhasePhase 2
SponsorSun Yat-sen University
Started2026-06-01
Est. completion2028-11-01
Eligibility
Age18 Years – 75 Years
SexFEMALE
Healthy vol.Accepted
View on ClinicalTrials.gov →
NCT07610720