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Recruiting NCT06217185

The Efficacy and Safety of Pyrotinib, Trastuzumab Combined With Taxanes in the Treatment of Trastuzumab-treated HER2+ Advanced Breast Cancer (ABC).

Phase IV Interventional HER2-positive Breast Cancer Advanced Breast Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Pyrotinib, Trastuzumab, Taxanes, Capecitabine.
Who it may be relevant to
Registry conditions: HER2-positive Breast Cancer, Advanced Breast Cancer. Basic parameters: 18 years — 70 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

The Efficacy and Safety of Pyrotinib, Trastuzumab Combined With Taxanes in the Treatment of Early Trastuzumab-treated HER2+ Advanced Breast Cancer (ABC).

Overview

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

  • Drug Pyrotinib
    Pyrotinib 400mg qd po continuously
  • Drug Trastuzumab
    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
  • Drug Taxanes
    Taxanes: Usual clinical dose is administered, in a 21-day cycle.
  • Drug Capecitabine
    Capecitabine: 650mg/m2 each time, given twice daily

Primary outcome measures

  • PFS [Time frame: 24months]
Secondary outcome measures (5)
  • CNS-PFS [Time frame: 24months]
  • ORR [Time frame: 24months]
  • DCR [Time frame: 24months]
  • OS [Time frame: 24months]
  • Overall Number of Participants Who Experienced at Least One Adverse Event, Including Serious and Non-Serious Adverse Events [Time frame: 24months]

Eligibility criteria

Inclusion criteria

  • Age: 18-70 years old, female;
  • 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)

  • Imaging confirmed recurrent/metastatic breast cancer;
  • Patients who relapsed and metastasized three months after discontinuation of Trastuzumab treatment;
  • Have at least one measurable lesion (according to RECIST 1.1 criteria);
  • ECOG score of 0-2;
  • Expected life span ≥3 months;
  • Normal major organ function;
  • The researcher believes that the participant may benefit;
  • Volunteer to participate in this study, sign informed consent.

Exclusion criteria

Patients who meet any of the following criteria are not eligible for participation:

  • Have any confirmed history of drug allergies, or severe allergic reactions to any component of the investigational drug (NCI-CTCAE 5.0 grade > 3);
  • Patients in advanced stages who have undergone systemic treatment;
  • A history of serious heart diseases such as congestive heart failure, unstable angina, arrhythmia or myocardial infarction;
  • Suffer from serious pulmonary diseases, such as interstitial lung disease or pneumonia, pulmonary fibrosis, acute pulmonary diseases, etc.;
  • 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;
  • 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);
  • Other invasive tumors (including second primary breast cancer) that may affect the evaluation of results and adherence to the protocol;
  • Having undergone major surgical procedure or are yet to recover from major internal diseases within the 4 weeks prior to the study;
  • Any circumstance that the researcher considers the participant unfit to participate in the study.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • The Fourth Hospital of Hebei Medical University — Shijiazhuang

Identifiers

NCT: NCT06217185 · OBU-BC-II-101

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗