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

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

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).

Study Overview

• Status: Recruiting
• Conditions: Advanced Breast Cancer; HER2-positive Breast Cancer
• Intervention / Treatment: Drug: Pyrotinib; Drug: Trastuzumab; Drug: Taxanes; Drug: Capecitabine

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Phase 4

Contacts and Locations

Study Locations

• China
  • Hebei
    • Shijiazhuang, Hebei, China, 050000
      • Recruiting
      • The Fourth Hospital of Hebei Medical University
      • Contact: Lina zhang; Phone Number: 18531117825; Email: linazh_001@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Age: 18-70 years old, female;

2. 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)

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

Exclusion Criteria:

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

1. Have any confirmed history of drug allergies, or severe allergic reactions to any component of the investigational drug (NCI-CTCAE 5.0 grade > 3);
2. Patients in advanced stages who have undergone systemic treatment;
3. A history of serious heart diseases such as congestive heart failure, unstable angina, arrhythmia or myocardial infarction;
4. Suffer from serious pulmonary diseases, such as interstitial lung disease or pneumonia, pulmonary fibrosis, acute pulmonary diseases, etc.;
5. 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;
6. 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);
7. Other invasive tumors (including second primary breast cancer) that may affect the evaluation of results and adherence to the protocol;
8. Having undergone major surgical procedure or are yet to recover from major internal diseases within the 4 weeks prior to the study;
9. Any circumstance that the researcher considers the participant unfit to participate in the study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental arm; 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; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
CNS-PFS	the period of time from the start of treatment for cancer patients to the observation of intracranial progression , or death due to any reason	24months
ORR	the proportion of patients who have a partial or complete response to therapy	24months
DCR	the percentage of patients with advanced or metastatic cancer who have achieved complete response, partial response and stable disease to a therapeutic intervention in clinical trials of anticancer agents	24months
OS	the period of time from the start of treatment for cancer patients to the observation of death due to any reason	24months
Overall Number of Participants Who Experienced at Least One Adverse Event, Including Serious and Non-Serious Adverse Events	Adverse event (AE) severity was assessed according to the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 5.0 (NCI-CTCAE v5.0); if the AE was not specifically listed, the following grades of severity were used: Grade 1 = mild; Grade 2 = moderate; Grade 3 = severe; Grade 4 = life-threatening or disabling; and Grade 5 = death. Severe and serious are not synonymous. Severity refers to the intensity of an AE, whereas a serious AE must meet criteria set out in the protocol; both were independently assessed for each AE. Only the most severe intensity was counted for multiple occurrences of the same AE in one participant.	24months

Collaborators and Investigators

• Sponsor: Hebei Medical University Fourth Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 2, 2024
• Primary Completion (Estimated): December 11, 2025
• Study Completion (Estimated): June 30, 2027

Study Registration Dates

• First Submitted: December 24, 2023
• First Submitted That Met QC Criteria: January 11, 2024
• First Posted (Actual): January 22, 2024

Study Record Updates

• Last Update Posted (Actual): February 28, 2024
• Last Update Submitted That Met QC Criteria: February 26, 2024
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms; Molecular Mechanisms of Pharmacological Action; Antimetabolites, Antineoplastic; Antimetabolites; Antineoplastic Agents; Antineoplastic Agents, Immunological; Trastuzumab; Capecitabine; Taxane
• Other Study ID Numbers: OBU-BC-II-101

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No