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This is a multi-center real-world study, in which patients who meet the inclusion criteria will receive treatment with Pyrotinib + Trastuzumab + Taxanes. Taxanes will be used for 6-8 cycles or discontinued due to intolerable Adverse Events (AEs), after which Capecitabine will be used for rhythmic chemotherapy combined with Pyrotinib + Trastuzumab. The aim is to explore the efficacy and safety of Pyrotinib, Trastuzumab, and Taxanes in treating Trastuzumab-treated HER2+ Advanced Breast Cancer (ABC).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental arm | Experimental | Pyrotinib, Trastuzumab Combined With Taxanes *When taxane drugs are discontinued (after completing 6-8 cycles of treatment or due to intolerance), the therapy can be continued with the combination of metronomic capecitabine and trastuzumab, along with pyrotinib. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pyrotinib | Drug | Pyrotinib 400mg qd po continuously |
| |
| Measure | Description | Time Frame |
|---|---|---|
| PFS | the period of time from the start of treatment for cancer patients to the observation of disease progression, or death due to any reason | 24months |
| Measure | Description | Time Frame |
|---|---|---|
| CNS-PFS | the period of time from the start of treatment for cancer patients to the observation of intracranial progression , or death due to any reason | 24months |
| ORR | the proportion of patients who have a partial or complete response to therapy |
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Inclusion Criteria:
Age: 18-70 years old, female;
Pathological examination confirmed HER-2 positive invasive breast cancer; (HER2 positivity is defined as an immunohistochemical (IHC) score of 3+ or in-situ hybridization (ISH) result for HER2 gene amplification in >10% of immunoreactive cells.
HER2 positivity needs to be verified by the pathology department of the research center involved in this study)
Imaging confirmed recurrent/metastatic breast cancer;
Patients who relapsed and metastasized three months after discontinuation of Trastuzumab treatment;
Have at least one measurable lesion (according to RECIST 1.1 criteria);
ECOG score of 0-2;
Expected life span ≥3 months;
Normal major organ function;
The researcher believes that the participant may benefit;
Volunteer to participate in this study, sign informed consent.
Exclusion Criteria:
Patients who meet any of the following criteria are not eligible for participation:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Fourth Hospital of Hebei Medical University | Recruiting | Shijiazhuang | Hebei | 050000 | China |
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| Trastuzumab |
| Drug |
For Trastuzumab, the loading dose for the first treatment cycle is 8 mg/kg, and for subsequent cycles, 6 mg/kg. It is to be used once every three weeks |
|
| Taxanes | Drug | Taxanes: Usual clinical dose is administered, in a 21-day cycle. |
|
| Capecitabine | Drug | Capecitabine: 650mg/m2 each time, given twice daily |
|
| 24months |
| DCR | the percentage of patients with advanced or metastatic cancer who have achieved complete response, partial response and stable disease to a therapeutic intervention in clinical trials of anticancer agents | 24months |
| OS | the period of time from the start of treatment for cancer patients to the observation of death due to any reason | 24months |
| Overall Number of Participants Who Experienced at Least One Adverse Event, Including Serious and Non-Serious Adverse Events | Adverse event (AE) severity was assessed according to the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 5.0 (NCI-CTCAE v5.0); if the AE was not specifically listed, the following grades of severity were used: Grade 1 = mild; Grade 2 = moderate; Grade 3 = severe; Grade 4 = life-threatening or disabling; and Grade 5 = death. Severe and serious are not synonymous. Severity refers to the intensity of an AE, whereas a serious AE must meet criteria set out in the protocol; both were independently assessed for each AE. Only the most severe intensity was counted for multiple occurrences of the same AE in one participant. | 24months |
| ID | Term |
|---|---|
| C000622954 | pyrotinib |
| D000068878 | Trastuzumab |
| D043823 | Taxoids |
| D000069287 | Capecitabine |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D005472 | Fluorouracil |
| D014498 | Uracil |
| D011744 | Pyrimidinones |
| D003853 | Deoxyribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
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