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A Multicenter, Randomized, Open, Phase III Trial of ddEC-THPvs Evaluating the Efficacy and Safety of TCHP Neoadjuvant Therapy for HER2-positive Breast Cancer | Clinical Trials | Clareo Health

UNKNOWNPHASE3

A Multicenter, Randomized, Open, Phase III Trial of ddEC-THPvs Evaluating the Efficacy and Safety of TCHP Neoadjuvant Therapy for HER2-positive Breast Cancer

A Multicenter, Randomized, Open, Phase III Trial of ddEC-THP（Epirubicin，Cyclophosphamide，TAX(Taxol)，Trastuzumab，Pertuzumab）vs Evaluating the Efficacy and Safety of TCHP （CBP(Carboplatin),TXT(Taxotere),Trastuzumab，Pertuzumab）Neoadjuvant Therapy for HER2-positive Breast Cancer

NCT05871918•Tianjin Medical University Cancer Institute and Hospital

View on ClinicalTrials.gov

Summary

The study is being conducted to assess the efficacy and safety of anthracycline-containing ddEC-THP intensive regimen and an anthracycline-free TCbHP neoadjuvant therapy for HER2-positive breast cancer

Detailed Description

A Multicenter, Randomized, Open, Phase III，The study is being conducted to assess the efficacy and safety of anthracycline-containing ddEC-THP intensive regimen and an anthracycline-free TCbHP neoadjuvant therapy for HER2-positive breast cancer,Subjects will be treated until disease progression, toxicity is intolerable, informed consent is withdrawn, and investigators determine that medication must be discontinued. Drug efficacy and safety data will be collected.

Eligibility

Age

18 - 70 years

Sex

FEMALE

Healthy Volunteers

Inclusion Criteria

•1. Age: 18 \~70 years old, female;
•2. Histologically confirmed patients with previously untreated stage Ⅱ-Ⅲ HER2-positive breast cancer;
•3. HER-2 positive breast cancer, defined as immunohistochemical (IHC) detection of 3+ or in situ hybridization (FISH) results of HER2 gene amplification;
•4. There is at least one measurable objective lesion according to RECIST 1.1 criteria;
•5. ECOG Physical fitness score is 0-2;
•6. Left ventricular ejection fraction LVEF≥50%;
•7. Bone marrow function: neutrophils ≥1.5×109/L, platelets ≥100×109/L, hemoglobin ≥90g/L;
•8. Liver and kidney function: serum creatinine ≤1.5 times the upper limit of normal value; AST and ALT≤2.5 times the upper limit of normal, or ≤5 times the upper limit of normal in the presence of liver metastasis; Total bilirubin ≤1.5 times the upper limit of normal, or ≤2.5 times the upper limit of normal in patients with Gilbert's syndrome, creatinine clearance greater than 30 mL/min;
•9. For female patients who are not menopausal or have not been surgically sterilized: consent to abstinence or use an effective contraceptive method during treatment and for at least 7 months after the last dose in the study treatment
•10. The patient has good compliance with the planned treatment, can understand the research process of the study and sign the written informed consent.

Exclusion Criteria

•1. Stage IV (metastatic) breast cancer patients;
•2. Patients with inflammatory breast cancer
•3. Serious heart disease or discomfort, including but not limited to:
•* History of heart failure or systolic dysfunction (LVEF \< 50%)
•* High-risk uncontrolled arrhythmias such as atrial tachycardia, resting heart rate \> 100 bpm, significant ventricular arrhythmias (e.g., ventricular tachycardia) or higher-grade atrioventricular block (i.e., Mobitz II second-degree atrioventricular block or third-degree atrioventricular block) Angina pectoris that requires antiangina medication
•* valvular heart disease of clinical significance
•* ECG showed transmural myocardial infarction
•* Poor hypertension control (systolic blood pressure \> 180 mmHg and/or diastolic blood pressure \> 100 mmHg)
•4. Known allergic history of drug components of this protocol; A history of immunodeficiency, including HIV positive, or other acquired, congenital immunodeficiency diseases, or a history of organ transplantation;
•5. Patients with severe systemic infection or accompanied by other serious diseases;
+5 more criteria

Locations (1)

Breast Oncology, Tianjin Medical University Cancer Institute and Hospital

Tianjin, Tianjin Municipality, China

Key Dates

Start Date

October 8, 2022

Primary Completion Date

December 31, 2023

Completion Date

December 31, 2023

Last Updated

May 23, 2023

Enrollment

832

ESTIMATED participants

Conditions

HER-2 Positive Breast Cancer

Interventions

TCbHP VS ddEC-THP

DRUG

Contacts

Zhongsheng Tong

CONTACT

+8618622221181 18622221181@163.com

Lin Gu

CONTACT

+8613011309052 gulindr@126.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: May 23, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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A Multicenter, Randomized, Open, Phase III Trial of ddEC-THPvs Evaluating the Efficacy and Safety of TCHP Neoadjuvant Therapy for HER2-positive Breast Cancer

Inclusion Criteria

Exclusion Criteria

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