- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05042791
A Study of Pyrotinib Plus Capecitabine Combined With SRT in HER2+ MBC With Brain Metastases
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
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Phase 2
Contacts and Locations
Study Contact
- Name: Chunling no Jiang, Dr.
- Phone Number: +86 13979109200
- Email: jclil2002@163.com
Study Locations
-
-
Jiangxi
-
Nanchang, Jiangxi, China, 330029
- Recruiting
- Jiangxi Cancer Hospital of Nanchang University
-
Contact:
- Chunling Jiang, MD,PHD
- Phone Number: +8613979109200
- Email: jclil2002@163.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
- Any other circumstances that are not suitable for inclusion in this study (investigator assessment)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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. |
This study selects different radiation (SRT or WBRT) combined with pyrotinib and capecitabine to treat HER2-positive advanced breast cancer patients with brain metastases
|
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. |
This study selects different radiation (SRT or WBRT) combined with pyrotinib and capecitabine to treat HER2-positive advanced breast cancer patients with brain metastases
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
CNS-ORR
Time Frame: Estimated up to 1 year
|
Objective response rate of central nervous system
|
Estimated up to 1 year
|
Collaborators and Investigators
Investigators
- Principal Investigator: Chunling Jiang, Jiangxi Provincial Cancer Hospital
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Skin Diseases
- Neoplasms
- Neoplasms by Site
- Breast Diseases
- Central Nervous System Neoplasms
- Nervous System Neoplasms
- Breast Neoplasms
- Brain Neoplasms
- Molecular Mechanisms of Pharmacological Action
- Antimetabolites, Antineoplastic
- Antimetabolites
- Antineoplastic Agents
- Capecitabine
Other Study ID Numbers
- 20210901-jiangchunling
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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