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

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexFemale
Age18-75
SponsorSun Yat-sen University

About this trial

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 criteria

Qualifiers

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • Dalpiciclib
  • Trastuzumab (Herceptin)
  • Pertuzumab
  • Pyrotinib
  • Endocrine Therapy 1

Treatment groups

57 Participants
are divided into 1 treatment group

Sponsors and collaborators