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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Trastuzumab combined with Pyrotinib and chemotherapy | Experimental | 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The subject continued to use the drug until the full cycle or the disease progressed or the toxicity was intolerable or withdrawn, or the researcher judged that the medication must be terminated. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Trastuzumab combined with Pyrotinib and chemotherapy | Drug | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| pathological complete response (pCR) | Breast without invasive carcinoma and carcinoma in situ or only carcinoma in situ (ypT0 or ypT0/is) | From enrollment to 18 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| overall survival (OS) | From the date of enrollment to the time of death due to any cause | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Tao Ouyang, MD | Contact | 88271119-5002 | ouyanghongtao@263.net |
| Name | Affiliation | Role |
|---|---|---|
| Tao Ouyang, MD | Peking University Cancer Hospital & Institute | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking University Cancer Hospital | Recruiting | Beijing | Beijing Municipality | 100142 | China |
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| ID | Term |
|---|---|
| C000622954 | pyrotinib |
| D004358 | Drug Therapy |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
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| At least two years |