A Phase 2 interventional study of Trastuzumab combined with Pyrotinib and chemotherapy in HER2-positive Breast Cancer, sponsored by Peking University. Recruiting at 1 site in China. Open to female participants aged 18 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-07-22.
Sponsored by Peking University · Phase 2, Interventional, and Treatment
This study is a one-arm, open, phase II clinical study, and the study subjects are locally advanced and inflammatoryPatients with sexual or early HER2-positive breast cancer entered the trial period after signing informed consentTo evaluate trastuzumab combined with pyrrolitinib and chemotherapy regimen (TCbH+Py) for HER2 positive breastPathologic complete response rate (pCR) for adenocarcinoma.
This study is a single-arm, open, phase II clinical study. The subjects are patients with locally advanced, inflammatory, or early HER2-positive breast cancer. The patients enter the trial period after signing informed consent. This study aims to evaluate trastuzumab The pathological complete response rate (pCR) of anti-combined pyrrotinib and chemotherapy (TCbH+Py) in the treatment of HER2-positive breast cancer.
The subjects began to take continuous medication after joining the group, and the total duration of medication was 6 cycles. Three to four weeks after the end of treatment, the surgeon will choose radical mastectomy, modified radical mastectomy or breast-sparing surgery according to the individual conditions of the patient. Regardless of whether the pCR is achieved, the adjuvant trastuzumab therapy or trastuzumab plus pertuzumab therapy is continued after the operation, and the total course of anti-HER2 therapy is up to 1 year (about 18 treatment cycles). According to the clinical stage and molecular classification of the tumor, it is necessary to decide whether adjuvant radiotherapy, chemotherapy and endocrine therapy are needed.
After the subject finishes all treatments, the subjects who are out of the group for non-PD and non-death causes need to receive the validity Follow-up until PD, start receiving other anti-tumor drug treatment or death (whichever comes first).
12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.
This study's planned enrollment of 104 is above the median of 72 across 9,303 interventional studies indexed under Breast Neoplasms.
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Exclusion Criteria:
The dosage of the above drugs can be adjusted according to the adverse reactions of the subjects. The subject continued to use the drug until the full cycle or the disease progressed or the toxicity was intolerable or withdrawn, or the researcher judged that the medication must be terminated.
Drug: Trastuzumab combined with Pyrotinib and chemotherapy
Pyrotinib is a small molecule, irreversible tyrosine kinase inhibitor with targets of epidermal growth factor receptor 1 (EGFR/HER1/ErbB1), human epidermal factor receptor 2 (HER2/ErbB2/Neu) and human epidermis Factor Receptor 4 (HER4/ErbB4). As a new generation of anti-HER2 therapeutic targeted drugs, pirotinib covalently binds to the ATP binding sites of the kinase regions of EGFR, HER2 and HER4 in cells to prevent homogeneity and heterogeneity of EGFR, HER2 and HER4 in tumor cells Dimer formation, inhibiting its own phosphorylation, blocking the activation of downstream signaling pathways, thereby inhibiting tumor cell growth
pathological complete response (pCR)
Breast without invasive carcinoma and carcinoma in situ or only carcinoma in situ (ypT0 or ypT0/is)
Time frame: From enrollment to 18 weeks
overall survival (OS)
From the date of enrollment to the time of death due to any cause
Time frame: At least two years
Safety index
ECOG PS score, vital signs, physical examination, laboratory examination indicators, ECG, echocardiography, adverse events (AE) according to NCI-CTC AE 5.0 standard
Time frame: At least two years
Plan to share: No
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