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

ConditionsAdvanced/Metastatic Breast CancerHER2-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

This trial does not accept healthy volunteers

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

Design model

Single group

Treatments tested in this trial

  • 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)

Treatment groups

57 Participants
are divided into 1 treatment group
Group A: Dalpiciclib + Endocrine Therapy + Trastuzumab ± Pertuzumab or PyrotinibExperimental treatment 5 interventions

Trial outcomes

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

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.

Secondary outcomes

1

Objective Response Rate (ORR)

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

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.
2

Overall Survival (OS)

Time from enrollment to death from any cause

Time frame
From randomization until the end of the study (approximately 36 months)
3

Safety and Tolerability

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

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.
4

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

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.

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.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Sun Yat-sen University

Lead sponsor

Source ClinicalTrials.gov
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