Status:
RECRUITING
Pyrotinib Maleate, Trastuzumab, SHR6390 and Letrozole in Combination for Stage II-III TPBC
Lead Sponsor:
Shengjing Hospital
Conditions:
Breast Cancer
Eligibility:
FEMALE
18-75 years
Phase:
PHASE2
Brief Summary
NOAH study confirmed that trastuzumab combined with chemotherapy can significantly improve PCR compared with chemotherapy alone, and established the status of trastuzumab as a new adjuvant targeted th...
Detailed Description
This multi-center, single-arm, open-label trial will include 12 patients with stage II-III triple-positive breast cancer. After providing written informed consent, the participants will undergo combin...
Eligibility Criteria
Inclusion
- Women aged≥18 years and ≤75 years meeting one of the following conditions;
- Those previously receiving ovariectomy, or aged ≥60 years
- Those aged \< 60 years who have had 12 consecutive months of amenorrhoea without any pathological or physical causes, and have postmenopausal E2 and follicle stimulating hormone (FSH) levels
- Premenopausal or perimenopausal women who are willing to receive LHRH agonist treatment during the study period
- Women who have breast cancer histopathologically confirmed by positive estrogen receptor (ER; \>10%), positive progesterone receptor (PR; \>1%), and positive human epidermal growth factor receptor 2 (HER2) according to the 2018 American Society of Clinical Oncology/College of American Pathologists (ASCO/CAP) human epidermal growth factor receptor 2 (HER2) guideline. ER, PR and HER2 will be assessed by immunohistochemistry (IHC) on harvested tissue. ER, PR and HER2 will be considered positive if the IHC result is positive (score 3+), or the IHC result is positive (2+) and in situ hybridization (ISH) amplification rate (≥2.0);
- Women having stage II-III breast cancer diagnosed based on AJCC cancer staging system (8th edition) who will be admitted because of breast cancer for the first time;
- Karnofsky Performance Status (KPS) Scale score ≥70;
- The functional level of organs must meet the following requirements:
- a) Bone marrow function i) Absolute neutrophil count（ANC）≥1.5×109/L (no use of growth factor within 14 days) ii) Platelet count（PLT）≥100×109/L (no corrective treatment within 7 days) iii) Hemoglobin level（Hb）≥100 g/L (no corrective treatment within 7 days) b) Liver and kidney function i) Total bilirubin（TBIL）≤1.5 upper limit of normal value (ULN) ii) Alanine transaminase (ALT) and aspartate transaminase (AST) ≤3×ULN iii) Blood urea nitrogen (BUN) and creatinine ≤1.5×ULN and creatinine clearance≥50 mL/min (Cockcroft-Gault formula); c) Color Doppler echocardiography: Left ventricular ejection fraction ≥50% d) 12-lead electrocardiography: QTc interval ≤480 ms
- Women who can undergo a biopsy;
- Volunteers to participate in the study, provision of signed informed consent, good compliance and willingness to cooperate with follow-ups.
Exclusion
- Women who have received any form of anti-tumor treatment - (chemotherapy, radiotherapy, molecular targeted therapy, or endocrine therapy);
- Those who have received other anti-tumor drug treatments concurrently;
- Those who have bilateral breast cancer, inflammatory breast cancer or occult breast cancer;
- Those who have stage IV breast cancer;
- Those who have breast cancer not histopathologically confirmed;
- Those who have other malignant tumors (with the exception of healed cervical carcinoma in situ) occurring in the past 5 years;
- Those who have severe dysfunction of the heart, liver, kidney, and other major organs;
- There are multiple factors that affect drug administration and absorption, such as inability to swallow, chronic diarrhea, and intestinal obstruction;
- Those who have participated in other clinical drug trials in the past 4 weeks;
- Those who are known to have a history of allergy to the component of study drugs; those who have a history of immunodeficiency, including positive detection of human immunodeficiency virus, hepatitis C virus, active hepatitis B or other acquired, congenital immunodeficiency diseases, or organ transplantation;
- Those who had suffered from any heart disease, including arrhythmia which requires drug treatment or is of clinical significance; myocardial infarction; heart failure; and any other heart disease judged by the investigator as unsuitable for this trial;
- Pregnant and lactating women; fertile women who provide positive results of baseline pregnancy test; women of childbearing age who are unwilling to take effective contraceptive measures during the whole study period;
- If the accompanying diseases (including, but not limited to, severe hypertension, severe diabetes, and active infection, which cannot be controlled by drugs) that would be a potential hazard to participant's health, or affect the completion of the study as per investigator's judgement;
- A clear history of neurological or psychiatric disorders, including epilepsy or dementia. Upon the suggestion of the investigators for other reasons
Key Trial Info
Start Date :
February 10 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2027
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT05228951
Start Date
February 10 2022
End Date
December 31 2027
Last Update
September 13 2022
Active Locations (1)
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1
Shengjing Hospital of China Medical University
Shenyang, Liaoning, China, 110004