SRT Versus WBRT Combined With Pyrrotinib and Capecitabine in the Treatment of HER2-positive Advanced Breast Cancer Patients With Brain Metastases: A Randomized Controlled, Prospective Clinical Study

Who is this study for? Patients with HER2-positive advanced breast cancer with brain metastases
What treatments are being studied? SRT+Pyrotinib+Capecitabine
Status: Recruiting
Location: See location...
Intervention Type: Combination product
Study Type: Interventional
Study Phase: Phase 2
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.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• 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%

‣ 12-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.

Locations
Other Locations
China
Jiangxi Cancer Hospital of Nanchang University
RECRUITING
Nanchang
Contact Information
Primary
Chunling no Jiang, Dr.
jclil2002@163.com
+86 13979109200
Time Frame
Start Date: 2022-03-01
Estimated Completion Date: 2025-09-30
Participants
Target number of participants: 362
Treatments
Experimental: SRT combined with pyrotinib and capecitabine
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.
Active_comparator: WBRT combined with pyrotinib and capecitabine
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.
Related Therapeutic Areas
Sponsors
Leads: Jiangxi Provincial Cancer Hospital

This content was sourced from clinicaltrials.gov

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