Pyrotinib Maleate Tablets Combined With Albumin Paclitaxel and Trastuzumab for Her2-positive Breast Cancer

NCT04152057 | Unknown Phase 1

• 1 other identifier: BLTN-NeoBC1115
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

This study was designed to evaluate the efficacy and safety of pyrotinib combined with albumin paclitaxel and trastuzumab in the treatment of Her2-positive early or locally advanced breast cancer, and to explore RCB scores and TILs expression and other related molecular markers for pyrrole the efficacy of the treatment with pyrotinib.

Conditions

Breast Cancer; HER2 Positive; Combination Chemotherapy

Keywords

Pyrotinib Maleate Tablets; Trastuzumab; Albumin Paclitaxel; Early or Locally Advanced; neoadjuvant

Outcome Measures

Primary Outcomes (1)

• pathologic Complete Response(pCR)（ypT0/is N0）

  Invasive tumor residuals in the breast and axillary lymph nodes without microscopic examination, ductal carcinoma in situ may exist.

  Postoperative evaluation after completion of neoadjuvant therapy (approximately 24 weeks) .

Secondary Outcomes (4)

• Overall Response Rate (ORR)

  up to 2 years

• Disease Control Rate (DCR)

  up to 2 years

• Residual Cancer Burden (RCB)

  up to 2 years

• Tumor Infiltrating Lymphocytes (TILS)

  up to 2 years

Study Arms (1)

Pyrotinib Combined With Albumin Paclitaxel and Trastuzumab

EXPERIMENTAL

Preoperative -Drug: Pyrotinib Maleate Tablets combined with Albumin Paclitaxel and Trastuzumab. Surgery:Subjects should be evaluated by tumor-enhanced MRI combined with mammary gland ultrasound during the preoperative neoadjuvant administration, and evaluated every 2 cycles. The subjects who were evaluated for CR and PR for the first time should be confirmed after at least 4 weeks. The confirmed tumor assessment cannot change the previously fixed examination time point. Postoperative * Drug: Epirubicin hydrochloride combined with Cyclophosphamide * At the same time, according to the recommendation of the clinician, choose whether to accept the same anti-HER2 treatment plan before surgery. For patients with tumors positive for estrogen receptor (ER) and/or progesterone receptor (PR), endocrine therapy should be given at the end of adjuvant chemotherapy, and if there is clinical indication at the end of adjuvant chemotherapy, radiotherapy should be given.

Drug: Pyrotinib Maleate Tablets; Drug: Albumin Paclitaxel; Drug: Trastuzumab

Interventions

Pyrotinib Maleate Tablets DRUG

400mg/d,po qd,q3w, 4 cycles

Also known as: Malaisuan Biluotini Pian, Ai Rui Ni

Pyrotinib Combined With Albumin Paclitaxel and Trastuzumab

Albumin Paclitaxel DRUG

125mg/m2,ivggt,d1,q3w,4 cycles.

Also known as: Ai Yue

Pyrotinib Combined With Albumin Paclitaxel and Trastuzumab

Trastuzumab DRUG

The first week load dose 4mg / kg, followed by 2mg / kg per week, d1,ivggt,q3w,4 cycles.

Also known as: Qutuozhu DanKang, Herceptin

Pyrotinib Combined With Albumin Paclitaxel and Trastuzumab

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years old, and ≤ 70 years old .
• ECOG full body status 0-1 .
• According to the RECIST 1.1 standard, at least one measurable lesion exists.
• The pathological examination confirmed the positive expression of HER2, the clinical stage was stage II-III \[cT2 and any N, cT3 and any N; cT4 and any N, according to the American Joint Committee on Cancer (AJCC) criteria\] breast cancer patients .
• Note: HER2 expression positive refers to the pathological detection/review of primary or metastatic lesions performed by the pathology department of the Institute of Research and Development, at least once, at least 10% of tumor cells have immunohistochemical staining intensity of 3+ \[staining intensity\] Range 0 to 3\] or positive by fluorescence in situ hybridization \[FISH\].
• The functional level of organs must meet the following requirements: ANC≥1.5×10E+9/L,PLT≥90×10E+9/L,Hb≥90 g/L,TBIL≤1.5×ULN,ALT 和 AST≤2×ULN,BUN 和 Cr≤ 1.5×ULN 且Creatinine clearance ≥50 mL/min（Cockcroft-Gault）.Echocardiography:LVEF≥50%,12-lead ECG:The QT interval (QTcF) corrected by the Fridericia method was \< 450 ms for males and \< 470 ms for females.
• Patients with known hormone receptor status .
• In patients with a negative serum pregnancy test, patients with fertility potential must agree to use an effective non-hormonal contraceptive method during treatment and at least 6 months after the last use of the test drug.
• Volunteered to join the study, signed informed consent, had good compliance and was willing to cooperate with follow-up.

You may not qualify if:

• Not selected as a subject in any of the following circumstances
• Patients with inflammatory breast cancer .
• Patients with metastatic breast cancer (stage IV) .
• Unable to swallow, chronic diarrhea and intestinal obstruction, there are many factors affecting the administration and absorption of drugs .
• Patients who received radiotherapy, chemotherapy, surgery (large surgery for breast cancer) or molecular targeted therapy 4 weeks before randomization were randomized to receive endocrine therapy within 7 days prior to randomization.
• Participated in other drug clinical trials within 4 weeks before randomization .
• The body has previously used or is using HER2-targeted monoclonal antibodies or tyrosine kinase inhibitor (including Trastuzumab,Pertuzumab,Lapatinib,Linatinib and Pyrotinib).
• Has had other malignant tumors in the past 5 years, excluding cured cervical carcinoma in situ, cutaneous basal cell carcinoma or cutaneous squamous cell carcinoma.
• Also accept any other anti-tumor treatment .
• Known to have a history of allergies to the drug components of this regimen; history of immunodeficiency, including HIV positive, or other acquired, congenital immunodeficiency disease, or history of organ transplantation .
• Have had any heart disease, including: (1) angina; (2) drug-treated or clinically significant arrhythmia; (3) myocardial infarction; (4) heart failure; (5) any subject judged Other heart diseases that are not suitable for this trial, etc.
• Female patients in pregnancy or lactation, female patients with fertility and positive pregnancy test, or women of childbearing age who are unwilling to take effective contraceptive measures during the whole trial period.
• According to the investigator's judgment, there are serious concomitant diseases that are harmful to the patient's safety or affect the patient's completion of the study (including but not limited to severe hypertension, severe diabetes, active infection, etc. that the drug cannot control).
• Have a clear history of neurological or mental disorders, including epilepsy or dementia.
• Accompanying CYP3A4 inhibitor or inducer .

Sponsors & Collaborators

• West China Hospital: lead
• Jiangsu HengRui Medicine Co., Ltd.: collaborator

Study Sites (1)

West China Hospital, Sichuan University

Chengdu, Chengdu, Sichuan, China, 610041, China

RECRUITING

Related Publications (1)

• Zhong X, He P, Chen J, Yan X, Wei B, Zhang Z, Bu H, Li J, Tian T, Lv Q, Wang X, Li H, Wang J, Huang J, Suo J, Liu X, Zheng H, Luo T. Neoadjuvant pyrotinib plus trastuzumab and nab-paclitaxel for HER2-positive early or locally advanced breast cancer: an exploratory phase II trial. Gland Surg. 2022 Jan;11(1):216-225. doi: 10.21037/gs-21-911.

  PMID: 35242683 DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Trastuzumab

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Ting Luo, MD

  West China Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ting Luo, MD

CONTACT

+8618602866299; tina621@163.com

Ting Luo, MD

CONTACT

+8618980606230; tina621@163.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assisting staff

Study Record Dates

• First Submitted: October 31, 2019
• First Posted: November 5, 2019
• Study Start: November 1, 2019
• Primary Completion: April 1, 2020
• Study Completion: April 1, 2021
• Last Updated: November 5, 2019

Record last verified: 2019-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)