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Pyrotinib Combined With Trastuzumab, Dalpiciclib, Letrozole Versus TCbHP (Trastuzumab Plus Pertuzumab With Docetaxel and Carboplatin) as Neoadjuvant Treatment in HR +/HER2 + Breast Cancer

NCT05638594 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 236

Last updated 2023-03-20

No results posted yet for this study

Summary

This is an investigator-initiated randomized controlled, open-label, multicenter, prospective Phase 2 clinical study. Patients with stage II-III HR +/HER2 + breast cancer were randomly divided into two groups at a ratio of 1:1. The experimental group received pyrotinib combined with trastuzumab, dalpiciclib and letrozole; the control group received trastuzumab combined with pertuzumab, docetaxel and carboplatin. The main study objective was to evaluate the efficacy and safety of neoadjuvant therapy for HR +/HER2 + breast cancer in the two groups.

Conditions

Interventions

DRUG

Pyrotinib

320mg, qd

DRUG

Trastuzumab

8 mg/kg first dose, then 6 mg/kg，q3w

DRUG

Dalpiciclib

125mg , qd，d1-21, q4w

DRUG

Letrozole

2.5mg，qd

DRUG

Pertuzumab

840 mg first dose, then 420 mg, q3w

DRUG

Docetaxel

75 mg/m2, q3w

DRUG

Carboplatin

AUC 6, q3w

DRUG

Gonadotropin-releasing hormone agonist

Every 4 weeks for 5 cycles, premenopausal patients only

Sponsors & Collaborators

  • Shengjing Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2022-12-20
Primary Completion
2025-12-10
Completion
2027-12-10

Countries

  • China

Study Locations

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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 NCT05638594 on ClinicalTrials.gov