Pyrotinib Combined With Brain Radiotherapy in Breast Cancer Patients With Brain Metastases

Study Purpose

Brain metastases occur in 30-50% of patients with metastatic HER2-positive breast cancer. Pyrotinib is an irreversible pan-ErbB receptor tyrosine kinase inhibitor (TKI) with activity against epidermal growth factor receptor (EGFR)/HER1, HER2, and HER4. This study consists of two parts. In a phase Ib part, investigators will explore the safety and tolerance of Pyrotinib Plus Capecitabine combined with brain radiotherapy. After completing the phase Ib part, investigators will review the data and decide whether this patient is included in before the start of a phase II part. In the phase II part, investigators will evaluate the efficacy of Pyrotinib Plus Capecitabine combined with brain radiotherapy in patients with HER2 positive breast cancer patients with brain metastases.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years and Over
Gender	Female

More Inclusion & Exclusion Criteria

Inclusion Criteria:

1. Pathologically confirmed HER2 positive advanced breast cancer. 2. Age>18 years. brain metastases confirmed by enhanced brain MRI. 3. KPS≥70. 4. Life expectancy of more than 12 weeks. 5. Prior therapy of oral dexamethasone not exceeding 16mg/d. 6. Time interval from prior therapy was more than 2 weeks, and evaluation of adverse events is no more than grade 1. 7. Maximum diameter of intracranial metastases is less than 3cm measured by enhanced brain MRI(2-3mm) 8. Prior endocrine therapy were allowed. 9. Anti-Her2 targeted treatment were allowed. 10. Screening laboratory values must meet the following criteria( and should be obtained within 28 days prior to registration): 1. Absolute Neutrophil Count (ANC) ≥ 1.5 x 109/L, Platelets≥ 90 x 109/L, Hemoglobin ≥ 90 g/L. 2. Aspartate aminotransferase/alanine aminotransferase (AST/ALT) ≤2.5 x ULN without liver metastasis,≤ 5 x ULN with liver metastases. 3. Serum BUN and creatinine ≤ 1.5 x Upper Limit of Normal (ULN) 4. LVEF ≥ 50% 5. QTcF < 480 ms. 6. INR≤1.5×ULN，APTT≤1.5×ULN. 11. Signed the informed consent form prior to patient entry.

Exclusion Criteria:

1. Leptomeningeal or hemorrhagic metastases. 2. uncontrolled epilepsy. 3. Severe complication: cardiovascular disease, end-stage renal disease, severe hepatic disease, infection etc. 4. Pregnancy or lactation period， women of child-bearing age who are unwilling to accept contraceptive measures. 5. Inability to complete enhanced MRI. 6. Patients who are difficult or unable to be followed-up. 7. Not suitable for inclusion for specific reasons judged by sponsor. 8. Patients unable to swallow, with chronic diarrhea, intestinal obstruction, or multiple factors that affect drug use and absorption. 9. History of allergy to pyrotinib or capetabine. 10. History of immunodeficiency, including HIV positive, active HBV/HCV or other acquired, congenital immunodeficiency disease, or organ transplantation history. 11. Previous use of pyrotinib combined with capetabine

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT04582968
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	Phase 1/Phase 2
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Fudan University
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Xiaoli Yu, MD PhD
Principal Investigator Affiliation	Fudan University
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Recruiting
Countries	China
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Breast Cancer, Brain Metastases, HER2-positive Breast Cancer

Arms & Interventions

Arms

Experimental: Pyrotinib Plus Capecitabine combined with brain radiotherapy

Fractionated stereotactic radiotherapy(FSRT) or whole brain radiation therapy (WBRT) Drug: Pyrotinib combined with capecitabine pyrotinib 400 mg once daily; Capecitabine 1000 mg/m2 per day on day 1 through 14, every 21 days.

Interventions

Other: - Pyrotinib Plus Capecitabine combined with brain radiotherapy

Drug combined with radiation

Contact a Trial Team

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International Sites

Fudan University Shanghai Cancer Center, Shanghai, China

Status

Recruiting

Address

Fudan University Shanghai Cancer Center

Shanghai, , 200032

Site Contact

Zhaozhi Yang

[email protected]

+8618017317126

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