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

NCT06217185 | Recruiting Phase 4

• 1 other identifier: OBU-BC-II-101
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

HER2-positive Breast Cancer; Advanced Breast Cancer

Outcome Measures

Primary Outcomes (1)

• PFS

  the period of time from the start of treatment for cancer patients to the observation of disease progression, or death due to any reason

  24months

Secondary Outcomes (5)

• CNS-PFS

  24months

• ORR

  24months

• DCR

  24months

• OS

  24months

• Overall Number of Participants Who Experienced at Least One Adverse Event, Including Serious and Non-Serious Adverse Events

  24months

Study Arms (1)

Experimental arm

EXPERIMENTAL

Pyrotinib, Trastuzumab Combined With Taxanes \*When taxane drugs are discontinued (after completing 6-8 cycles of treatment or due to intolerance), the therapy can be continued with the combination of metronomic capecitabine and trastuzumab, along with pyrotinib.

Drug: Pyrotinib; Drug: Trastuzumab; Drug: Taxanes; Drug: Capecitabine

Interventions

Pyrotinib DRUG

Pyrotinib 400mg qd po continuously

Experimental arm

Trastuzumab DRUG

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

Experimental arm

Taxanes DRUG

Taxanes: Usual clinical dose is administered, in a 21-day cycle.

Experimental arm

Capecitabine DRUG

Capecitabine: 650mg/m2 each time, given twice daily

Experimental arm

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hebei Medical University Fourth Hospital: lead

Study Sites (1)

The Fourth Hospital of Hebei Medical University

Shijiazhuang, Hebei, 050000, China

RECRUITING

MeSH Terms

Interventions

pyrotinib; Trastuzumab; Taxoids; Capecitabine

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 24, 2023
• First Posted: January 22, 2024
• Study Start: January 2, 2024
• Primary Completion: December 11, 2025
• Study Completion (Estimated): June 30, 2027
• Last Updated: February 28, 2024

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)