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

NCT07610720 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 57

Last updated 2026-05-28

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Endocrine Therapy 1

Letrozole 2.5mg, Anastrozole 1mg, Exemestane 25mg, or Fulvestrant 0.5g IM on Days 1, 28 (initial: Days 1, 15, 28)

DRUG

Trastuzumab (Herceptin)

Subcutaneous, 600mg Q3W; IV: 8mg/kg (loading) → 6mg/kg Q3W

DRUG

Pertuzumab

IV: 840mg (loading) → 420mg Q3W

DRUG

Pyrotinib

240mg qd Week 1 → 320mg qd from Week 2 (max dose); loperamide prophylaxis for diarrhea

DRUG

Dalpiciclib

Oral CDK4/6 inhibitor (dose modification permitted for toxicity management)

Sponsors & Collaborators

  • Sun Yat-sen University

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-06-01
Primary Completion
2028-11-01
Completion
2029-11-01

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07610720 on ClinicalTrials.gov