Pyrotinib Maleate Tablets Combined With Albumin Paclitaxel and Trastuzumab for Her2-positive Breast Cancer
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04152057|
Recruitment Status : Recruiting
First Posted : November 5, 2019
Last Update Posted : November 5, 2019
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer HER2 Positive Combination Chemotherapy||Drug: Pyrotinib Maleate Tablets Drug: Albumin Paclitaxel Drug: Trastuzumab||Phase 1 Phase 2|
At present, the treatment mode of breast cancer has gradually turned to the individualized comprehensive treatment mode combining systemic therapy and local therapy, and neoadjuvant therapy is widely used. Albumin-bound paclitaxel alters the excipients, reduces adverse reactions and greatly enhances efficacy, facilitating clinical applications. Studies have shown that in the use of neoadjuvant chemotherapy, drugs containing purple shirts and anthracyclines will be the drug of choice. The HER2/erbB2 molecule is an independent prognostic factor for breast cancer. About 20%-30% of adenocarcinoma patients have amplification/overexpression of HER2 gene. These patients are insensitive to conventional therapy and are more prone to recurrence and metastasis. Shorter survival and poorer prognosis. Current drugs targeting HER2 targets mainly include macromolecular monoclonal antibodies and their conjugates and small molecule tyrosine kinase inhibitors. Pyrotinib is an irreversible inhibitor of small targets (EGFR and HER2). Compared with trastuzumab, it has different sites of action, which may lead to synergy in the treatment of human Her2-positive breast cancer.
The excellent clinical efficacy of dual-targeted neoadjuvant therapy for Her2 positive breast cancer, the anti-tumor effect and good tolerance of pyrotinib, we intend to develop a pyrotinib combined with albumin paclitaxel and trastuzumab one-arm exploratory clinical study of neoadjuvant therapy for Her2-positive early or locally advanced breast cancer with the aim of assessing efficacy and safety, and exploring the efficacy of tumor-associated molecular markers such as RCB scores and TILs expression for pyrotinib treatment predicting effectiveness.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Single-arm, Exploratory Clinical Study of Pyrotinib Maleate Tablets Combined With Albumin Paclitaxel and Trastuzumab for Her2-positive Early or Locally Advanced Breast Cancer and Its Biomarkers|
|Estimated Study Start Date :||November 2019|
|Estimated Primary Completion Date :||April 2020|
|Estimated Study Completion Date :||April 2021|
Experimental: Pyrotinib Combined With Albumin Paclitaxel and Trastuzumab
-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.
Drug: Pyrotinib Maleate Tablets
400mg/d,po qd,q3w, 4 cycles
Drug: Albumin Paclitaxel
Other Name: Ai Yue
The first week load dose 4mg / kg, followed by 2mg / kg per week, d1,ivggt,q3w,4 cycles.
- pathologic Complete Response(pCR)（ypT0/is N0） [ Time Frame: Postoperative evaluation after completion of neoadjuvant therapy (approximately 24 weeks) . ]Invasive tumor residuals in the breast and axillary lymph nodes without microscopic examination, ductal carcinoma in situ may exist.
- Overall Response Rate (ORR) [ Time Frame: up to 2 years ]The proportion of patients with a best overall confirmed response of CR or PR in the whole body as assessed per RECIST 1.1 by the investigator.
- Disease Control Rate (DCR) [ Time Frame: up to 2 years ]The proportion of patients with a best overall response of CR, PR or SD in the whole body, as assessed per RECIST1.1 by the investigator.
- Residual Cancer Burden (RCB) [ Time Frame: up to 2 years ]The RCB category (RCB-0, RCB-I, RCB-II, or RCB-III) was defined according to the M.D. Anderson Cancer Center standard, and the RCB score was associated with the patient's prognosis.
- Tumor Infiltrating Lymphocytes (TILS) [ Time Frame: up to 2 years ]This outcome measure is designed to measure the amount of TILs in newly diagnosed luminal A and Triple Negative Breast Cancer (TNBC) tumors. The mean percent change in TILS in tumor tissue from initial core biopsy samples will be compared with pathology samples from definitive surgery after IORT between the two different breast cancer sub types.
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): NCT04152057
|Contact: Ting Luo, MDemail@example.com|
|Contact: Ting Luo, MDfirstname.lastname@example.org|
|China, Chengdu, Sichuan, China|
|West China Hospital, Sichuan University||Recruiting|
|Chengdu, Chengdu, Sichuan, China, China, 610041|
|Contact: Ting Luo, MD +8618602866299 email@example.com|
|Contact: Ting Luo, MD +8618980606230 firstname.lastname@example.org|
|Principal Investigator:||Ting Luo, MD||West China Hospital|