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

NCT07610720 | Recruiting Phase 2 DMC

• 1 other identifier: DALTINA
• Study Type: interventional
• Target: 57
• Locations: 1 country
• Sites: 1

Brief 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

Advanced/Metastatic Breast Cancer; HER2-Positive Metastatic Breast Cancer

Keywords

Dalpiciclib; Dalpiciclib Plus Anti-HER2 Therapy and Endocrine Therapy

Outcome Measures

Primary Outcomes (1)

• Progression-Free Survival (PFS)

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

  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.

Secondary Outcomes (5)

• Objective Response Rate (ORR)

  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.

• Overall Survival (OS)

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

• Safety and Tolerability

  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.

• Disease-Specific Quality of Life Assessed by EORTC QLQ-BR45

  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.

• Quality of Life Assessed by EORTC QLQ-C30

  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.

Study Arms (1)

Dalpiciclib + Endocrine Therapy + Trastuzumab ± Pertuzumab or Pyrotinib

EXPERIMENTAL

Drug: Dalpiciclib; Drug: Trastuzumab (Herceptin); Drug: Pertuzumab; Drug: Pyrotinib; Drug: Endocrine Therapy 1

Interventions

Dalpiciclib DRUG

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

Dalpiciclib + Endocrine Therapy + Trastuzumab ± Pertuzumab or Pyrotinib

Trastuzumab (Herceptin) DRUG

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

Dalpiciclib + Endocrine Therapy + Trastuzumab ± Pertuzumab or Pyrotinib

Pertuzumab DRUG

IV: 840mg (loading) → 420mg Q3W

Dalpiciclib + Endocrine Therapy + Trastuzumab ± Pertuzumab or Pyrotinib

Pyrotinib DRUG

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

Dalpiciclib + Endocrine Therapy + Trastuzumab ± Pertuzumab or Pyrotinib

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)

Dalpiciclib + Endocrine Therapy + Trastuzumab ± Pertuzumab or Pyrotinib

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (1)

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

Guangdong, GUANGZHOU, 510060, China

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Interventions

dalpiciclib; Trastuzumab; pertuzumab; pyrotinib

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Central Study Contacts

Chen Doctor Chen, PhD / Doctorate

CONTACT

02087341812; chenmt@sysucc.org.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Department of Medical Oncology Professor, Principal Investigator, Chief Physician

Study Record Dates

• First Submitted: May 6, 2026
• First Posted: May 28, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): November 1, 2028
• Study Completion (Estimated): November 1, 2029
• Last Updated: May 28, 2026

Record last verified: 2026-05

Locations

CN (1)