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

NCT07766772 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2026-08-14

No results posted yet for this study

Summary

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.

Conditions

Interventions

DRUG

Trastuzumab Rezetecan

Administer intravenously at a dose of 4.8 mg/kg every 3 weeks (Q3W), with each 3-week period constituting one treatment cycle.

DRUG

Pyrotinib

Take orally once daily, 400 mg each time.

DRUG

trastuzumab

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.

DRUG

Capecitabine

Oral administration, 3 times a day, 500 mg each time

DRUG

endocrinotherapy（doctor's choice）

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

Sponsors & Collaborators

  • Fujian Cancer Hospital

    lead OTHER_GOV

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-09-30
Primary Completion
2031-12-31
Completion
2031-12-31

Countries

  • China

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07766772 on ClinicalTrials.gov