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Pyrotinib Combined With Trastuzumab and Chemotherapy Neoadjuvant Therapy for HER2-positive Breast Cancer

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ClinicalTrials.gov Identifier: NCT06035679
Recruitment Status : Recruiting
First Posted : September 13, 2023
Last Update Posted : February 28, 2024
Sponsor:
Information provided by (Responsible Party):
Youzhi Zhu, First Affiliated Hospital of Fujian Medical University

Study Description
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Brief Summary:
This study is a prospective, single-center, observational clinical study, The objection was to observe the treatment of pyrotinib combined with trastuzumab and neoadjuvant chemotherapy Efficacy of Stage II-III breast cancer and observation of the efficacy of step-down neoadjuvant therapy for HER2-positive stage T1cN0M0 breast cancer.

Condition or disease Intervention/treatment Phase
Breast Cancer Female Drug: Pyrotinib and Trastuzumab Not Applicable

Detailed Description:
This study is a prospective, single-center, observational clinical study,Which plan to be enroll 30 patients with HER2-positive early breast cancer receive pyrotinib combined with trastuzumab and chemotherapy neoadjuvant therapy. The primary endpoint was the total pathological complete response rate (tpCR) , The objection was to observe the treatment of pyrotinib combined with trastuzumab and neoadjuvant chemotherapy Efficacy of Stage II-III breast cancer and observation of the efficacy of step-down neoadjuvant therapy for HER2-positive stage T1cN0M0 breast cancer.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Prospective, Single-center, Observational Clinical Study of Pyrotinib Combined With Trastuzumab and Chemotherapy Neoadjuvant Therapy for HER2-positive Breast Cancer
Actual Study Start Date : August 17, 2023
Estimated Primary Completion Date : November 30, 2026
Estimated Study Completion Date : November 30, 2026

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
Drug Information available for: Trastuzumab

Arms and Interventions
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Arm Intervention/treatment
Experimental: Pyrotinib Combined With Trastuzumab and Chemotherapy
T1cN0M0 HER2+ breast cancer Patients received 2 cycles (pyrotinib + trastuzumab + taxoid) regimen and were evaluated to continue with the original regimen if PR, and 4 cycles (pyrotinib + trastuzumab + taxoid + carboplatin) regimen if SD/PD. Phase II-III HER2+ breast cancer Patients received 6 cycles of treatment (pyrotinib + trastuzumab + taxoid + carboplatin)
 Drug: Pyrotinib and Trastuzumab
Small and large molecules combined with chemotherapy for neoadjuvant treatment of HER2-positive breast cancer
Other Name: dual HER2 blockade in the neoadjuvant setting


Outcome Measures
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Primary Outcome Measures :
  1. tpCR [ Time Frame: at surgery ]
    total Pathological Complete Response


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Female patients aged 18-75 years;
  2. Her2-positive breast cancer confirmed by pathology;
  3. invasive breast cancer confirmed by histology, Tumor stage: early stage (T1c-3, N0-1, M0) or locally advanced stage (T2-4, N2, N3, M0);
  4. ECOG PS: 0-1 score;
  5. Plan to undergo the final surgical removal of breast cancer, i.e. breast conserving surgery or total mastectomy, sentinel lymph node (SN) biopsy or axillary lymph node dissection (ALND)
  6. Normal function of major organs means that the following criteria are met:

(1) Blood test neutrophil (ANC) >=1.5x10^9/L; Platelet count (PLT) >=90x10^9/L; Hemoglobin (Hb) >=90g/L; (2) Total bilirubin (TBIL) <=1.5 upper limit of normal (ULN); Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) <=1.5xULN; Alkaline phosphatase <=2.5xULN; Urea nitrogen (BUN) and creatinine (Cr) <=1.5xULN; (3) Left ventricular ejection fraction (LVEF) >=55%; (4) The QT interval (QTcF) corrected by Fridericia method was less than 470msec in 12-lead ECG; 7. For women who have not undergone menopause or surgical sterilization: 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); 8. Volunteer to participate in this study, sign the informed consent, have good compliance and be willing to cooperate with follow-up.

Exclusion Criteria:

  1. Known allergic history of the drug components of this protocol;
  2. Previous or co-existing other malignant tumors, except cured basal cell carcinoma of the skin and carcinoma in situ of the cervix;
  3. Participated in clinical trials of other antitumor drugs within four weeks;
  4. Stage IV (metastatic) breast cancer;
  5. Multiple factors affecting oral medication (e.g., inability to swallow, post-gastrointestinal resection, chronic diarrhea, and intestinal obstruction);
  6. A history of congestive heart failure (CHF) or uncontrolled heart disease (angina, arrhythmia, hypertension);
  7. Patients with active infection and severe mental illness;
  8. Pregnant or lactating patients;
  9. Patients with allergies or known history of allergies to the drug components of this protocol; A history of immunodeficiency, including being HIV positive, or having other acquired or congenital immunodeficiency diseases, or a history of organ transplantation;
  10. Concomitant diseases that, in the judgment of the investigator, seriously endanger the patient's safety or interfere with the patient's completion of the study.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06035679


Contacts
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Contact: zhu youzhi 17759120588 zhu@fjmu.edu.cn

Locations
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China, Fujian
The First Affiliated Hospital of Fujan Medical University Recruiting
Fuzhou, Fujian, China
Contact: youzhi zhu, master         
Sponsors and Collaborators
Youzhi Zhu
Investigators
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Study Chair: zhu youzhi First Affiliated Hospital of Fujian Medical University
More Information
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Responsible Party: Youzhi Zhu, Clinical Professor, First Affiliated Hospital of Fujian Medical University
ClinicalTrials.gov Identifier: NCT06035679    
Other Study ID Numbers: OBU-BC-II-95
First Posted: September 13, 2023    Key Record Dates
Last Update Posted: February 28, 2024
Last Verified: September 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: There is not a plan to make IPD available

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
 Skin Diseases
Trastuzumab
Antineoplastic Agents, Immunological
Antineoplastic Agents