A Prospective, Open, Multicenter Single-arm Clinical Studie of Docetaxel, Carboplatin Combined With Inetetamab and Pyrotinib in the Treatment of Local-advanced HER2-positive Breast Cancer (neoPICD)

This study is a prospective, open, multi-center, single arm trial. The treatment group will receive six cycles of docetaxel, carboplatin combined with Inetetamab and Pyrotinib before surgery. By focusing on tpCR (ypT0/is, ypN0) evaluated by pathology, the efficacy of docetaxel, carboplatin combined with Inetetamab and Pyrotinib in the preoperative treatment of locally advanced HER2-positive breast cancer will be evaluated. During long-term follow-up, event-free survival (EFS), disease-free survival (DFS), distant metastasis-free survival (DDFS), overall survival (OS), central nervous system disease-free survival (CNSDFS) under this treatment regimen will be evaluated, and the efficacy-related biomarkers will be explored. The cardiotoxicity of Inetetamab and Pyrotinib in the treatment of breast cancer is also be evaluated.

Study Overview

• Status: Recruiting
• Conditions: Breast Neoplasm Female
• Intervention / Treatment: Drug: Docetaxel; Drug: Carboplatin; Drug: Inetetamab; Drug: Pyrotinib

• Study Type: Interventional
• Enrollment (Estimated): 154
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Zhejiang
    • Wenzhou, Zhejiang, China, 325000
      • Recruiting
      • The First Affiliated Hospital of Wenzhou Medical University
      • Contact: Wang OC Ouchen, Doctor; Phone Number: 13957706099; Email: woc099@163.com
      • Sub-Investigator: Wu WZ Weizhu, Doctor
      • Sub-Investigator: Li XY Xiaoyang, Master
      • Sub-Investigator: Cao FL Feilin, Doctor
      • Sub-Investigator: Wu WL Weili, Master
      • Principal Investigator: Wang OC Ouchen, Doctor

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Female patients aged 18-75 years old;
2. ECOG score 0-1;
3. Breast cancer meets the following criteria: Histologically confirmed invasive breast cancer, primary tumor diameter > 2 cm as determined by standard evaluation methods at the research center; tumor stage: locally advanced;
4. HER2 expression-positive breast cancer confirmed by pathological examination;
5. Known hormone receptor status (ER and PR);
6. The functional level of major organs must meet the following requirements (no blood transfusion within 2 weeks before screening, no use of white blood cell and platelet-raising drugs):

(1) Blood routine: neutrophil (ANC) >= 1.5×10^9/L; platelet count (PLT) >= 90×10^9/L; hemoglobin (Hb) >= 90 g/L; (2) Blood biochemistry: total bilirubin (TBIL) <= upper limit of normal (ULN); alanine aminotransferase (ALT) and aspartate aminotransferase (AST) <= 1.5×ULN; alkaline phosphatase <= 2.5×ULN; urea nitrogen (BUN) and creatinine (Cr) <= 1.5×ULN; (3) Echocardiography: left ventricular ejection fraction (LVEF) >= 60%; (4) 12-lead ECG: Fridericia-corrected QT interval (QTcF) < 470 msec; 7. Female patients who are not menopausal or surgically sterilized: agree to abstain from sex or use effective contraceptive methods during treatment and for at least 7 months after the last dose in the study treatment; 8. Voluntarily join the study, sign the informed consent, have good compliance and are willing to cooperate with follow-up.

Exclusion Criteria:

1. IV (metastatic) breast cancer;
2. Received anti-tumor therapy or radiotherapy for any malignant tumor in the past, excluding cured cervical carcinoma in situ, basal cell carcinoma or squamous cell carcinoma and other malignant tumors;
3. Receiving anti-tumor therapy in other clinical trials at the same time, including endocrine therapy, bisphosphonate therapy or immunotherapy;
4. Received major surgical operations unrelated to breast cancer within 4 weeks before enrollment, or the patient has not fully recovered from such surgical operations;
5. Severe cardiac disease or discomfort, including but not limited to the following: a history of heart failure or systolic dysfunction (LVEF < 60%); high-risk uncontrolled arrhythmias, such as atrial tachycardia, resting heart rate > 100 bpm , significant ventricular arrhythmia (eg, ventricular tachycardia) or higher-grade AV block (ie, Mobitz II second-degree AV block or third-degree AV block); antianginal medication indicated angina pectoris; clinically significant heart valve disease; transmural myocardial infarction on ECG; poorly controlled hypertension (systolic > 180 mmHg and/or diastolic > 100 mmHg);
6. Inability to swallow, intestinal obstruction, or other factors that affect drug taking and absorption;
7. Those who are known to have a history of allergy to the drug components of this regimen; have a history of immunodeficiency, including HIV positive test, or have other acquired or congenital immunodeficiency diseases, or have a history of organ transplantation;
8. Female patients during pregnancy and lactation, female patients with fertility and positive baseline pregnancy test, or patients of childbearing age who are unwilling to take effective contraceptive measures during the entire trial period and within 7 months after the last study drug;
9. Have serious comorbidities or other comorbidities that would interfere with planned treatment, or any other condition that the investigator considers the patient unsuitable to participate in this study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: treatment arm	Drug: Docetaxel; 75mg/m2 iv escalating to 100mg/m2 iv 3-weekly; Drug: Carboplatin; AUC=6 min/mL iv 3-weekly; Drug: Inetetamab; 8mg/kg iv loading dose, followed by 6mg/kg iv 3-weekly; Other Names: cipterbin; Drug: Pyrotinib; 400mg orally daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
tpCR	total pathological complete response	Approximately 5 months from randomization following surgery or early withdrawal, whichever occurred first (Surgery was performed within 2 weeks after Cycle 6)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
OS	Overall survival	Up to 2 years
EFS	Event-free survival	Randomization up to a maximum of 329 weeks
DFS	Disease-free survival	Randomization up to a maximum of 329 weeks
DDFS	Distant disease free survival	Randomization up to a maximum of 329 weeks
CNS-DFS	Central nervous system disease-free survival	Randomization up to a maximum of 329 weeks

Collaborators and Investigators

• Sponsor: Wang Ouchen

Study record dates

Study Major Dates

• Study Start (Actual): November 27, 2021
• Primary Completion (Estimated): July 31, 2025
• Study Completion (Estimated): August 1, 2031

Study Registration Dates

• First Submitted: January 23, 2024
• First Submitted That Met QC Criteria: January 23, 2024
• First Posted (Estimated): January 31, 2024

Study Record Updates

• Last Update Posted (Estimated): January 31, 2024
• Last Update Submitted That Met QC Criteria: January 23, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Docetaxel; Carboplatin
• Other Study ID Numbers: KY2021-113

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No