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

NCT ID: NCT06217185

Last Updated: 2024-02-28

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-01-02
• Study Completion Date: 2027-06-30

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Pyrotinib

Intervention Type: DRUG

Pyrotinib 400mg qd po continuously

Trastuzumab

Intervention Type: 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

Taxanes

Intervention Type: DRUG

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

Capecitabine

Intervention Type: DRUG

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

Interventions

Pyrotinib

Pyrotinib 400mg qd po continuously

Intervention Type: 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

Intervention Type: DRUG

Taxanes

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

Intervention Type: DRUG

Capecitabine

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

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Hebei Medical University Fourth Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

The Fourth Hospital of Hebei Medical University

Shijiazhuang, Hebei, China

Site Status: RECRUITING

Countries

China

Facility Contacts

Lina zhang

Role: primary

linazh_001@163.com

18531117825

Other Identifiers

OBU-BC-II-101

Identifier Type: -

Identifier Source: org_study_id