Dalpiciclib, Anti-HER2 Therapy, and Endocrine Therapy for Hormone-Receptor-Positive, HER2-Positive Metastatic Breast Cancer
Recruiting · NCT07610720 · Interventional (participants receive a specific treatment) · Lead sponsor: Sun Yat-sen University
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
Age range
18 Years to 75 Years
Sex
Female
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 2
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- 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.
Exclusion criteria
- 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
1 location listed.
- Sun yat-Sen University Cancer Center, Guangzhou, Yuexiu District - Guangdong, GUANGZHOU, China