Status:
RECRUITING
Trastuzumab Combined With Pyrrolidine and Chemotherapy for Locally HER2 Positive Breast Cancer
Lead Sponsor:
Peking University
Conditions:
HER2-positive Breast Cancer
Eligibility:
FEMALE
18-70 years
Phase:
PHASE2
Brief Summary
This study is a one-arm, open, phase II clinical study, and the study subjects are locally advanced and inflammatoryPatients with sexual or early HER2-positive breast cancer entered the trial period a...
Detailed Description
This study is a single-arm, open, phase II clinical study. The subjects are patients with locally advanced, inflammatory, or early HER2-positive breast cancer. The patients enter the trial period afte...
Eligibility Criteria
Inclusion
- Female between 18 and 70 years old;
- Histologically confirmed as invasive breast cancer;
- ECOG PS 0-1;
- The expected survival time is not less than 12 weeks;
- Standard immunohistochemical HER2-positive breast cancer patients (IHC +++ or FISH amplification);
- The status of hormone receptors (ER and PR) can be known.
- Clinical examination or imaging examination of primary lesion \>2cm;
- Patients who are operable (T2-3, N0-1, M0), locally advanced (T2-3,N2-3, M0 or T4A-C, any N, M0) or inflammatory breast cancer (T4d, any N, M0) and who have not received any previous anti-tumor therapy (including radiotherapy, chemotherapy, targeted therapy, except those who have received bisphosphonate therapy previously);
- Echocardiography indicated left ventricular ejection fraction (LVEF)≥55%;
- Adequate organ and bone marrow function, as defined below: a. Neutrophil count (ANC)≥ 1,500/mm3 (1.5 × 109/L); B. Platelet count (PLT)≥ 100,000/mm3(100 × 109/L); C. Hemoglobin (Hb)≥ 9 g/dL(90 g/L); D. Serum creatinine ≤ 1.5 times upper limit of normal value (ULN) or creatinine clearance ≥ 60 ml/min(based on Cockroft - Gault formula); E. Total bilirubin (BIL)≤ 1.5 times the upper limit of normal value (ULN); F. AST/SGOT or ALT/SGPT ≤ 2.5 times upper limit of normal value (ULN);G. Urinary protein \<2+; If urinary protein ≥2+, 24-hour urinary protein quantification shows protein must1 g or less;
- I have agreed and signed the informed consent, and am willing and able to comply with the planned visit, research treatment, laboratory examination and other test procedures.
Exclusion
- Have received any previous anti-tumor treatment for primary invasive breast cancer;
- Previous (\<10 years) or other malignant tumors, except for curable cancer species: a. basal cell carcinoma of skin and squamous cell carcinoma b. Carcinoma in situ of cervix
- For patients with other malignancies, they can also be included in the study if the time from diagnosis to enrollment exceeds 10 years; Prior surgical treatment is permitted except for radiotherapy or systemic therapy (chemotherapy or endocrine therapy);
- Metastatic breast cancer (M1), bilateral or ipsilateral multifocal breast cancer;
- Uncontrolled hypertension, systolic blood pressure \> 150 MMHG and/or diastolic blood pressure \> 100 MMHG), or clinical symptomatic cardiovascular disease, myocardial ischemia and myocardial infarction, severe/unstable angina, poor control of cardiac arrhythmias (including women according to Bazett formula correction QTc interphase \< 470 ms), symptoms of congestive heart failure, cerebrovascular accident (including transient ischemic attack or symptomatic cerebral embolism), NYHA Ⅱ magnitude cardiac insufficiency;
- Receive other anti-tumor treatments within 4 weeks before enrollment;
- Inability to swallow, intestinal obstruction or other factors affecting the use and absorption of medication;
- Persons with allergic constitution or known history of allergy to the drug components of the program;
- The patient has a severe concomitant disease or other conditions that the researcher considers inappropriate for the patient to participate in the studyIn any case;
- Non-surgically sterilized female patients of childbearing age must have negative serum or urine HCG tests within 14 days prior to study inclusion; And must be non-lactation
- Other circumstances deemed inappropriate for inclusion by the researcher.
Key Trial Info
Start Date :
July 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2026
Estimated Enrollment :
104 Patients enrolled
Trial Details
Trial ID
NCT04481932
Start Date
July 1 2020
End Date
December 1 2026
Last Update
July 22 2020
Active Locations (1)
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1
Peking University Cancer Hospital
Beijing, Beijing Municipality, China, 100142