This study is a single-arm, exploratory clinical trial, aiming to include patients with HER2-positive advanced breast cancer. It intends to explore the efficacy and safety of trastuzumab combined with pyrotinib, capecitabine ± endocrine therapy as a first-line maintenance treatment for HER2+ advanced breast cancer after induction therapy with rucaparib trastuzumab.
After the subjects meet the screening criteria and are enrolled, they receive induction therapy with rucaparib trastuzumab. Among them, patients without disease progression enter the maintenance treatment period and receive trastuzumab combined with pyrotinib, capecitabine ± endocrine therapy (±OFS) for treatment. Until disease progression, or toxicity becomes intolerable, or withdrawal of informed consent, or the investigator determines that the medication must be discontinued. During the study period, imaging evaluations are conducted according to the RECIST 1.1 standard, and the center assessment results are the final results.
During the study period, the efficacy indicators such as PFS, ORR, DOR, CBR, and safety indicators of the subjects are evaluated according to the established trial standards, and statistical descriptions are conducted.
Female participants aged 18 to 75 years (inclusive)
HER2-positive breast cancer confirmed by histology or cytology (HER2 positivity defined as IHC 3+ or ISH+ in primary or metastatic lesions); locally advanced or metastatic breast cancer not amenable to curative surgery (participants eligible for curative treatment are excluded);
Clear HR status (HR-positive defined as ER and/or PR positive in primary or metastatic lesions, with ≥1% of tumor cells showing ER and/or PR staining);
No prior systemic anticancer therapy during the recurrent/metastatic phase (except ≤1 line of endocrine therapy allowed);
Patients with active central nervous system metastases who have not undergone surgery or radiation therapy, except those whose condition has been stable for at least one month after treatment and who have discontinued corticosteroids for more than 2 weeks.
A history of other malignancies within the past 5 years, excluding cured cases of cutaneous basal cell carcinoma, cervical carcinoma in situ, and papillary thyroid carcinoma.
Presence of third-space fluid accumulation (e.g., large volume ascites, pleural effusion, pericardial effusion) that cannot be controlled by drainage or other means.
Patients who have received surgery (defined as major cancer-related surgery), radiation therapy, chemotherapy, immunotherapy, molecularly targeted therapy, biological therapy, or participated in other drug clinical trials within 4 weeks prior to the first dose of study medication.
Single group
Trastuzumab Rezetecan
DrugAdminister intravenously at a dose of 4.8 mg/kg every 3 weeks (Q3W), with each 3-week period constituting one treatment cycle.
Pyrotinib
DrugTake orally once daily, 400 mg each time.
trastuzumab
DrugIntravenous infusion: Initial dose 8mg/kg, subsequent dose 6mg/kg, 3 weeks as one cycle; Subcutaneous injection: Fixed dose 600mg (not based on the subject's weight), administration completed within 2-5 minutes, 3 weeks as one cycle.
Capecitabine
DrugOral administration, 3 times a day, 500 mg each time
endocrinotherapy（doctor's choice）
DrugAdminister the medication according to the recommended regimen specified in the doctor's instructions for endocrine therapy. For patients with HR-positive disease, they can choose to use
progression free survival(PFS)
The duration from the start of the induction period treatment to the observation of disease progression or the occurrence of death due to any cause.
objective remission rate(ORR)
The proportion of patients with a therapeutic response evaluated as Complete Response(CR) and Partial Response(PR)
duration of response(DoR)
It refers to the time period from the first evaluation as CR or PR (with the earlier occurrence taking precedence) until disease progression or death. The assessment is conducted using the RECIST 1.1 standard.
Clinical Benefit Rate(CBR)
The proportion of patients whose tumor volume has decreased by 30% or whose disease has remained stable (SD) for 24 weeks since the start of the assessment, which is the sum of the proportions of complete response (CR), partial response (PR), and disease stability (SD) maintained for 24 weeks as evaluated by the investigators based on the RECIST 1.1 standard.
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Through blood routine tests (such as hemoglobin, white blood cell count, neutrophil count, platelet count, etc.), liver and kidney function tests (such as albumin, total bilirubin, alanine aminotransferase, aspartate aminotransferase, alkaline phosphatase, urea nitrogen, creatinine, etc.), urine routine (such as urine protein, urine red blood cells, etc.), stool routine (stool occult blood), electrocardiogram (such as heart rate, QTc interval, etc.), echocardiography (left ventricular ejection fraction), etc., evaluate the changes in the values of corresponding tests during the treatment period. Classify and record the number of occurrences through CTCAE V5.0.
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