A Study of Pyrotinib Plus Capecitabine Combined With SRT in HER2+ MBC With Brain Metastases

NCT05042791 | Recruiting Phase 2

• 1 other identifier: 20210901-jiangchunling
• Study Type: interventional
• Target: 362
• Locations: 1 country
• Sites: 1

Brief Summary

This study evaluates the efficacy and safety of SRT combined with pyrotinib and capecitabine in the treatment of patients with HER2-positive advanced breast cancer patients with brain metastases.

Conditions

HER2-positive Metastatic Breast Cancer

Outcome Measures

Primary Outcomes (1)

• CNS-ORR

  Objective response rate of central nervous system

  Estimated up to 1 year

Study Arms (2)

SRT combined with pyrotinib and capecitabine

EXPERIMENTAL

SRT: SRT needs to be comprehensively considered based on the size, number, and location of the lesion, and SRS and FSRT are performed according to clinical needs. Pyrotinib:400mg/d,q.d.,p.o. A course of treatment need 21days. Capecitabine:1000mg/m2,bid,from day1-day14, A course of treatment need 21 days.

Combination Product: radiation combined with pyrotinib and capecitabine

WBRT combined with pyrotinib and capecitabine

ACTIVE COMPARATOR

WBRT: WBRT need to be considered based on the size, number, and location of the lesion. Pyrotinib:400mg/d,q.d.,p.o. A course of treatment need 21days. Capecitabine:1000mg/m2,bid,from day1-day14, A course of treatment need 21 days.

Combination Product: radiation combined with pyrotinib and capecitabine

Interventions

radiation combined with pyrotinib and capecitabine COMBINATION_PRODUCT

This study selects different radiation (SRT or WBRT) combined with pyrotinib and capecitabine to treat HER2-positive advanced breast cancer patients with brain metastases

SRT combined with pyrotinib and capecitabine; WBRT combined with pyrotinib and capecitabine

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age\> 18 years old, female
• KPS≥70
• HER2-positive breast cancer is confirmed by the pathology laboratory with an immunohistochemical (IHC) score of 3+ and/or 2+ and a positive in situ hybridization (ISH) test (ISH amplification rate ≥ 2.0)
• Brain metastasis confirmed by MRI, in line with the indications for whole brain radiotherapy
• At least one measurable brain lesion exists according to the RECIST 1.1 standard
• Unlimited number of previous chemotherapy lines
• Have not used capecitabine in the past, or progressed 6 months after capecitabine stopped, or progressed after capecitabine as adjuvant therapy stopped for one year
• The expected survival period is more than 12 weeks
• Patients must have adequate organ function, criteria as follows.
• Blood routine examination：Absolute Neutrophil Count (ANC)≥1.5×109/L；PLT ≥100×109/L； Hb ≥90g/L
• Blood chemistry test：TBIL ≤1.5 times the upper limit of normal (ULN); ALT and AST≤3 times ULN; For patients with liver metastases, ALT and AST≤5×ULN; BUN and Cr≤1×ULN and creatinine clearance ≥50mL/min (CockcroftGault formula);
• Ultrasonic cardiogram: LVEF≥50%
• lead ECG: The QT interval (QTcF) corrected by Fridericia's method is \< 470 ms
• Patients with known hormone receptor status
• Patients need to voluntarily join this study after they fully understand and sign the informed consent form. Patients need to have good compliance and be willing to cooperate with follow-up.

You may not qualify if:

• Patients with brain metastases with extensive meningeal metastasis
• Brain metastases within 5 mm of the hippocampus
• There are many factors that affect the administration and absorption of drugs, for example: inability to swallow, chronic diarrhea and intestinal obstruction
• Those who have received chemotherapy, surgical treatment (excluding local puncture) or molecular targeted therapy within 4 weeks before enrollment; those who have received anti-tumor endocrine therapy after the screening period
• Participated in other drug clinical trials within 4 weeks before enrollment
• Have used or are currently using HER2 tyrosine kinase inhibitors (lapatinib, niratinib, pyrotinib, etc.)
• Suffered from other malignant tumors in the past 5 years, excluding cured cervical carcinoma in situ, skin basal cell carcinoma or skin squamous cell carcinoma
• Receive any other anti-tumor therapy at the same time
• Those who are known to have a history of allergies to the drug; have a history of immunodeficiency, including positive HIV tests, HCV, active hepatitis B, or other acquired or congenital immunodeficiency diseases, or organ transplants history
• Have ever suffered from any heart disease, including: (1) arrhythmia requiring medication or clinical significance; (2) myocardial infarction; (3) heart failure; (4) anyone judged by the researcher as unsuitable for participation becase of other heart diseases in this trial, etc.
• Female patients during pregnancy and lactation, female patients with fertility and a positive baseline pregnancy test, or female patients of childbearing age who are unwilling to take effective contraceptive measures during the entire trial period
• According to the judgment of the investigator, there are accompanying diseases that seriously endanger the safety of the patient or affect the completion of the study (including but not limited to severe hypertension that cannot be controlled by drugs, severe diabetes, active infection, etc.)
• The patient has not recovered from the toxicity of the previous treatment to grade 0-1 (except for hair loss)
• Have a clear history of neurological or psychiatric disorders, including epilepsy or dementia
• Concomitant use of CYP3A4 inhibitors or inducers or drugs that prolong the QT interval

Sponsors & Collaborators

• Jiangxi Provincial Cancer Hospital: lead

Study Sites (1)

Jiangxi Cancer Hospital of Nanchang University

Nanchang, Jiangxi, 330029, China

RECRUITING

Related Publications (1)

• Dai L, Gao T, Guo R, Chen Y, Wang J, Zhou S, Tang Y, Chen D, Huang S. Efficacy and safety of pyrotinib-based regimens in HER2 positive metastatic breast cancer: A retrospective real-world data study. Neoplasia. 2024 Oct;56:101029. doi: 10.1016/j.neo.2024.101029. Epub 2024 Jul 17.

  PMID: 39024777 DERIVED

MeSH Terms

Interventions

pyrotinib; Capecitabine

Intervention Hierarchy (Ancestors)

Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Study Officials

• Chunling Jiang

  Jiangxi Provincial Cancer Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Chunling no Jiang, Dr.

CONTACT

+86 13979109200; jclil2002@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 6, 2021
• First Posted: September 13, 2021
• Study Start: March 1, 2022
• Primary Completion: September 30, 2025
• Study Completion: September 30, 2025
• Last Updated: February 9, 2024

Record last verified: 2024-02

Locations

CN (1)