Skip to main content
OpenTrials
Recruiting

NCT Number: NCT07610720

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

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Advanced/Metastatic Breast Cancer Breast Diseases Breast Neoplasms HER2-Positive Metastatic Breast Cancer Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year–75 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Sun yat-Sen University Cancer Center, Guangzhou, Yuexiu District

Guangdong, GUANGZHOU, 510060, China

Location status: Recruiting

About this study

This is a multicenter, single-arm, open-label, phase II clinical trial evaluating the efficacy and safety of dalpiciclib (a novel oral CDK4/6 inhibitor) combined with anti-HER2 therapy and endocrine therapy as maintenance treatment in patients with hormone receptor-positive (HR+)/HER2-positive metastatic breast cancer who have completed induction systemic therapy without disease progression.

Triple-positive (HR+/HER2+) metastatic breast cancer represents a unique subtype requiring dual pathway inhibition. Current standard first-line induction therapy includes taxane-based chemotherapy combined with trastuzumab and pertuzumab (THP) or pyrotinib (THPy), followed by maintenance with anti-HER2 therapy plus endocrine therapy. However, approximately 50% of patients progress within 18 months during maintenance therapy.

This study explores the addition of dalpiciclib to standard anti-HER2 and endocrine maintenance therapy to prolong progression-free survival. Dalpiciclib, the first domestically developed CDK4/6 inhibitor in China, has demonstrated favorable efficacy and a manageable safety profile in HR+/HER2- advanced breast cancer, with a lower incidence of febrile neutropenia and no observed interstitial lung disease.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Dalpiciclib

Drug

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

Trastuzumab (Herceptin)

Drug

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

Pertuzumab

Drug

IV: 840mg (loading) → 420mg Q3W

Pyrotinib

Drug

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

Endocrine Therapy 1

Drug

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

Primary outcomes

  1. Progression-Free Survival (PFS)

    Time frame: From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 2 years after the last participant completes treatment.

    Time from enrollment to radiographic disease progression (per RECIST 1.1) or death from any cause, whichever occurs first

Secondary outcomes

  1. Objective Response Rate (ORR)

    Time frame: From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 2 years after the last participant completes treatment.

    Proportion of patients achieving Complete Response (CR) or Partial Response (PR) per RECIST 1.1

  2. Overall Survival (OS)

    Time frame: From randomization until the end of the study (approximately 36 months)

    Time from enrollment to death from any cause

  3. Safety and Tolerability

    Time frame: From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 2 years after the last participant completes treatment.

    Incidence, type, severity, and relationship of adverse events (AEs) graded by NCI CTCAE v5.0

  4. Disease-Specific Quality of Life Assessed by EORTC QLQ-BR45

    Time frame: From the date of enrollment until the date of first documented progression or the date of death from any cause, whichever came first, assessed up to 2 years after the last participant completes treatment.

    Assessed by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Breast Cancer-Specific Module (EORTC QLQ-BR45). The EORTC QLQ-BR45 contains 45 items divided into functional and symptom scales evaluating breast cancer-specific issues and treatment side effects. All scales range in score from 0 to 100. A higher score for a functional scale represents a higher/healthy level of functioning, whereas a higher score for a symptom scale represents a higher level of breast cancer-related symptomatology or treatment-related problems.

  5. Quality of Life Assessed by EORTC QLQ-C30

    Time frame: From the date of enrollment until the date of first documented progression or the date of death from any cause, whichever came first, assessed up to 2 years after the last participant completes treatment.

    Assessed by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30). The EORTC QLQ-C30 consists of 30 items incorporating 5 functional scales, 3 symptom scales, a global health status scale, and 6 single items. All scales and single-item measures range in score from 0 to 100. A higher score for a functional scale or global health status represents a higher/healthy level of functioning, whereas a higher score for a symptom scale/item represents a higher level of symptomatology or problems.

Study contacts

Contact information is provided by the study sponsor or research team.

Chen Doctor Chen, PhD / Doctorate

CONTACT

[email protected]

02087341812

Sponsors and collaborators

Lead sponsor

Sun Yat-sen University

Other

Registry information

Official study title

Evaluating the Efficacy and Safety of Dalpiciclib Plus Anti-HER2 Therapy and Endocrine Therapy in Patients With Induction-Treated Hormone-Receptor-Positive, HER2-Positive Metastatic Breast Cancer

Important dates

Study start
2026
Primary completion
2028
Study completion
2029
First posted
May 28, 2026
Registry last updated
May 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.