Recruitment

Recruitment Status
Completed

Inclusion Criterias

BUN and creatine clearance rate: ≥ 50 mL/min
Signed informed consent.
QTcF: < 470 ms
...
BUN and creatine clearance rate: ≥ 50 mL/min
Signed informed consent.
QTcF: < 470 ms
Aged ≥18 and ≤70 years.
ALT and AST: ≤ 1.5 x ULN
ECOG performance status of 0 to 1.
ANC: ≥ 1.5 x 109/L
Hemoglobin: ≥ 9.0 g/dL
Histologically or cytologic confirmed HER2 positive advanced breast cancer which failed prior therapies.
At least one measurable lesion exists.(RECIST 1.1)
Life expectancy of more than 12 weeks.
LVEF: ≥ 50%
Total bilirubin: ≤ 1.5 x upper limit of normal, ULN
Platelet count: ≥ 100 x 109/L

Exclusion Criterias

Ongoing infection (determined by investigator).
Subjects with intracranial lesions.
Subjects with uncontrolled hypokalemia and hypomagnesemia before study entry.
...
Ongoing infection (determined by investigator).
Subjects with intracranial lesions.
Subjects with uncontrolled hypokalemia and hypomagnesemia before study entry.
Female patients of childbearing age that are reluctant to take effective contraceptive measures throughout the trial period.
Less than 4 weeks from the last radiotherapy,chemotherapy,surgery,hermone treatment,target therapy, or less than 6 weeks from the nitrosoureas or mitomycin chemotherapy.
Subjects with third space fluid that can not be controled by drainage or other methods.
Female patients who are pregnancy, lactation or women who are of childbearing potential tested positive in baseline pregnancy test.
Receiving any other antitumor therapy.
Less than 4 weeks from the last clinical trial.
Alcoholism, smoking (daily ≥ 5 roots) and other bad habits.
Known history of hypersensitivity to pyrotinib or any of it components.
Steroid treatment for more than 50 days, or in need of long-term use of steroids.
Known history of neurological or psychiatric disease, including epilepsy or dementia.
History of immunodeficiency, including HIV-positive, suffering from other acquired, congenital immunodeficiency disease, or history of organ transplantation.
Subjects that are unable to swallow tablets, or dysfunction of gastrointestinal absorption.
Subjects who can not interrupt the using of the drugs that may cause QT prolongation during study.
Subjects had any heart disease, including: (1) angina; (2) requiring medication or clinically significant arrhythmia; (3) myocardial infarction; (4) heart failure; (5) Any heart diseases judged by investigator as unsuitable to participate in the trial.
Evidence of significant medical illness that in the investigator's judgment will substantially increase the risk associated with the subject's participation in and completion of the study. Examples include, but are not limited to,hypertension, severe diabetes, or thyroid disease.
Treated or treating with HER2 tyrosine kinase inhibitors (TKIs) before study entry.

Summary

Conditions
Breast Cancer
Type
Interventional
Phase
Phase 1
Design
  • Allocation: N/A
  • Intervention Model: Single Group Assignment
  • Masking: None (Open Label)
  • Primary Purpose: Treatment

Participation Requirements

Age
Between 18 years and 70 years
Gender
Both males and females

Inclusion Criterias

BUN and creatine clearance rate: ≥ 50 mL/min
Signed informed consent.
QTcF: < 470 ms
...
BUN and creatine clearance rate: ≥ 50 mL/min
Signed informed consent.
QTcF: < 470 ms
Aged ≥18 and ≤70 years.
ALT and AST: ≤ 1.5 x ULN
ECOG performance status of 0 to 1.
ANC: ≥ 1.5 x 109/L
Hemoglobin: ≥ 9.0 g/dL
Histologically or cytologic confirmed HER2 positive advanced breast cancer which failed prior therapies.
At least one measurable lesion exists.(RECIST 1.1)
Life expectancy of more than 12 weeks.
LVEF: ≥ 50%
Total bilirubin: ≤ 1.5 x upper limit of normal, ULN
Platelet count: ≥ 100 x 109/L

Exclusion Criterias

Ongoing infection (determined by investigator).
Subjects with intracranial lesions.
Subjects with uncontrolled hypokalemia and hypomagnesemia before study entry.
...
Ongoing infection (determined by investigator).
Subjects with intracranial lesions.
Subjects with uncontrolled hypokalemia and hypomagnesemia before study entry.
Female patients of childbearing age that are reluctant to take effective contraceptive measures throughout the trial period.
Less than 4 weeks from the last radiotherapy,chemotherapy,surgery,hermone treatment,target therapy, or less than 6 weeks from the nitrosoureas or mitomycin chemotherapy.
Subjects with third space fluid that can not be controled by drainage or other methods.
Female patients who are pregnancy, lactation or women who are of childbearing potential tested positive in baseline pregnancy test.
Receiving any other antitumor therapy.
Less than 4 weeks from the last clinical trial.
Alcoholism, smoking (daily ≥ 5 roots) and other bad habits.
Known history of hypersensitivity to pyrotinib or any of it components.
Steroid treatment for more than 50 days, or in need of long-term use of steroids.
Known history of neurological or psychiatric disease, including epilepsy or dementia.
History of immunodeficiency, including HIV-positive, suffering from other acquired, congenital immunodeficiency disease, or history of organ transplantation.
Subjects that are unable to swallow tablets, or dysfunction of gastrointestinal absorption.
Subjects who can not interrupt the using of the drugs that may cause QT prolongation during study.
Subjects had any heart disease, including: (1) angina; (2) requiring medication or clinically significant arrhythmia; (3) myocardial infarction; (4) heart failure; (5) Any heart diseases judged by investigator as unsuitable to participate in the trial.
Evidence of significant medical illness that in the investigator's judgment will substantially increase the risk associated with the subject's participation in and completion of the study. Examples include, but are not limited to,hypertension, severe diabetes, or thyroid disease.
Treated or treating with HER2 tyrosine kinase inhibitors (TKIs) before study entry.

Locations

Beijing, Beijing, 100021
Beijing, Beijing, 100021

Tracking Information

NCT #
NCT01937689
Collaborators
Chinese Academy of Medical Sciences
Investigators
Not Provided