HER2-positive Breast Cancer, Advanced Breast Cancer
Conditions
Brief summary
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).
Interventions
DRUGPyrotinib
Pyrotinib 400mg qd po continuously
DRUGTrastuzumab
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
DRUGTaxanes
Taxanes: Usual clinical dose is administered, in a 21-day cycle.
DRUGCapecitabine
Capecitabine: 650mg/m2 each time, given twice daily
Sponsors
Hebei Medical University Fourth Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
1. Age: 18-70 years old, female; 2. 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) 3. Imaging confirmed recurrent/metastatic breast cancer; 4. Patients who relapsed and metastasized three months after discontinuation of Trastuzumab treatment; 5. Have at least one measurable lesion (according to RECIST 1.1 criteria); 6. ECOG score of 0-2; 7. Expected life span ≥3 months; 8. Normal major organ function; 9. The researcher believes that the participant may benefit; 10. Volunteer to participate in this study, sign informed consent.
Exclusion criteria
Patients who meet any of the following criteria are not eligible for participation: 1. Have any confirmed history of drug allergies, or severe allergic reactions to any component of the investigational drug (NCI-CTCAE 5.0 grade \> 3); 2. Patients in advanced stages who have undergone systemic treatment; 3. A history of serious heart diseases such as congestive heart failure, unstable angina, arrhythmia or myocardial infarction; 4. Suffer from serious pulmonary diseases, such as interstitial lung disease or pneumonia, pulmonary fibrosis, acute pulmonary diseases, etc.; 5. Currently suffering from severe liver-related diseases, such as acute hepatitis, explosive hepatitis, coagulation factor synthesis disorder, etc.; Those who are positive for HBV surface antigen or HBV core antibody must have a peripheral blood Hepatitis B virus DNA titer test \< 1×10 \^3 IU/ml in order to participate; 6. Comorbidity or condition that may interfere with their participation in the study, or any serious medical impediment that might affect participant's safety (such as, active or uncontrolled infection, active liver/gallbladder disease requiring antiviral treatment); 7. Other invasive tumors (including second primary breast cancer) that may affect the evaluation of results and adherence to the protocol; 8. Having undergone major surgical procedure or are yet to recover from major internal diseases within the 4 weeks prior to the study; 9. Any circumstance that the researcher considers the participant unfit to participate in the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| PFS | 24months | the period of time from the start of treatment for cancer patients to the observation of disease progression, or death due to any reason |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| CNS-PFS | 24months | the period of time from the start of treatment for cancer patients to the observation of intracranial progression , or death due to any reason |
| ORR | 24months | the proportion of patients who have a partial or complete response to therapy |
| DCR | 24months | 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 |
| OS | 24months | the period of time from the start of treatment for cancer patients to the observation of death due to any reason |
| Overall Number of Participants Who Experienced at Least One Adverse Event, Including Serious and Non-Serious Adverse Events | 24months | 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. |
Countries
China
Outcome results
None listed