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

Hebei Medical University

Status and phase: Enrolling; Phase 4

Conditions: HER2-positive Breast Cancer; Advanced Breast Cancer

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

Study type: Interventional

Funder types: Other

Identifiers

NCT06217185

OBU-BC-II-101

Details and patient eligibility

About

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).

Enrollment: 100 estimated patients

Sex: Female

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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100 participants in 1 patient group

Experimental arm

Experimental group

Description:

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.

Treatment:

Drug: Trastuzumab

Drug: Capecitabine

Drug: Taxanes

Drug: Pyrotinib