Trastuzumab Rezetecan Followed by Pyrotinib, and Trastuzumab Combined With Capecitabine as First-line Treatment for Advanced HER2-positive Breast Cancer

Sponsor
Fujian Cancer Hospital
Study ID
NCT07766772
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

  • Advanced Breast Cancer
  • HER2 + Breast Cancer

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Trastuzumab Rezetecan — DRUG
    Administer intravenously at a dose of 4.8 mg/kg every 3 weeks (Q3W), with each 3-week period constituting one treatment cycle.
  • Pyrotinib — DRUG
    Take orally once daily, 400 mg each time.
  • trastuzumab — DRUG
    Intravenous 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 — DRUG
    Oral administration, 3 times a day, 500 mg each time
  • endocrinotherapy（doctor's choice） — DRUG
    Administer 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

Study Details

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.

Key Dates

First listed
Aug 14, 2026
Start date
Sep 30, 2026
Status verified
Aug 2026
Primary completion
Dec 31, 2031
Completion
Dec 31, 2031

Study Design

Enrollment
50 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Trastuzumab Rezetecan followed by Pyrotinib + Trastuzumab + Capecitabine ± endocrine therapy Group
    After receiving Trastuzumab Rezetecan for Injection induction therapy, a combined treatment regimen of pyrotinib, trastuzumab, and capecitabine ± endocrine therapy was used for maintenance treatment.

Primary Outcome Measure

progression free survival(PFS) [ Time Frame: From enrollment to 3 years ]

Central Contacts

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