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This study adopts a multicenter, natural selection, observational design, and plans to enroll patients with HER-2 positive advanced or metastatic breast cancer treated at approximately 20 research centers nationwide. Patients with de novo stage IV disease or those with recurrent metastatic breast cancer who have not previously received trastuzumab, as well as patients with brain metastases, will be included for separate stratified efficacy analysis and will not be included in the overall analysis. The study plans to enroll effective data from 600 HER-2 positive advanced or metastatic breast cancer patients, who will be naturally allocated in a 1:1 ratio to either Group A (switching from HP + chemotherapy to HPy + chemotherapy) or Group B (switching from HPy + chemotherapy to HP + chemotherapy), with each group comprising approximately 300 patients. If first-line treatment fails, patients will switch to the alternative regimen in second-line treatment. All patients will continue treatment until disease progression, intolerable toxicity, or other reasons lead to discontinuation, with the number of treatment cycles recorded. The study is divided into three phases: screening/baseline period, treatment period (treatment period 1 + treatment period 2), and survival follow-up period. If patients develop intolerance to taxanes during treatment, clinicians may select alternative chemotherapy regimens such as vinorelbine, capecitabine, or eribulin based on clinical judgment. During the treatment period, patients will be followed up every two cycles, during which clinical data will be collected, including disease status assessments, laboratory tests, study drug usage, concomitant medications, and adverse events. After chemotherapy completion or treatment discontinuation, subsequent maintenance therapy, such as continued dual-targeted maintenance, may be administered by clinicians based on clinical needs until disease progression or intolerable toxicity occurs. Survival follow-up will be conducted every three months (for up to three years), with patient survival status recorded.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| B | The treatment plan was changed from HPy plus chemotherapy to HP plus chemotherapy. |
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| A | The treatment plan was changed from HP plus chemotherapy to HPy plus chemotherapy. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Antitumor treatment plan | Drug | This research project included valid data from 600 patients with HER-2 positive advanced or metastatic breast cancer. They were randomly divided into Group A (transition from HP + chemotherapy to HPy + chemotherapy) or Group B (transition from HPy + chemotherapy to HP + chemotherapy) in a 1:1 ratio. Each group had approximately 300 patients. If the patients failed in their first-line treatment, they would switch to another treatment regimen in the second-line treatment. All patients were stopped from treatment when their condition progressed, toxicity became intolerable, or for other reasons. The treatment cycles were recorded. |
| Measure | Description | Time Frame |
|---|---|---|
| PFS by Investigator assessment per RECIST 1.1 | The PFS of patients who had previously received trastuzumab treatment and then switched to another targeted therapy after progression following two targeted strategies after recurrence. | 60 mouths |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival (OS) | The OS of patients after conversion application of two targeted strategies in the treatment of post-progression cases. | 60 mouths |
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Inclusion Criteria:
Voluntarily signed the informed consent form with good compliance.
Female, aged 18 years or older.
Histologically confirmed diagnosis of HER2-positive advanced or metastatic breast cancer.
Metastatic lesions confirmed by MRI/contrast-enhanced CT, with at least one measurable lesion according to RECIST 1.1 criteria.
For patients previously treated with trastuzumab or tyrosine kinase inhibitors (TKIs) in the early-stage setting, recurrence must have occurred more than 1 year after the completion of prior treatment.
ECOG performance status score of 0-2.
Eligible patients meeting the treatment criteria specified in this study protocol may be included. This includes:Patients whose prior first-line and second-line treatments both align with the requirements of this protocolï¼›Patients currently receiving second-line treatment whose prior first-line treatment aligns with the requirements of this protocolï¼›The above populations may have previously received or not received trastuzumab and/or pertuzumab, small-molecule tyrosine kinase inhibitors (e.g., pyrotinib, etc.), and may include patients with brain metastases, among others.
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Exclusion Criteria:
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Patients with HER-2 positive advanced or metastatic breast cancer.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ziwen Zhang | Contact | +86 13588318799 | 16660496@qq.com |
| Name | Affiliation | Role |
|---|---|---|
| Hai Hu | Zhejiang Cancer Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zhejiang Cancer Hospital | Recruiting | Zhejiang | Hangzhou | 310000 | China |
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|
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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