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Clinical Trial NCT04481932 for HER2-positive Breast Cancer is recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here.
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Trastuzumab Combined With Pyrrolidine and Chemotherapy for Locally HER2 Positive Breast Cancer Phase 2 104

Recruiting
Clinical Trial NCT04481932 is designed to study Treatment for HER2-positive Breast Cancer. It is a Phase 2 interventional study that is recruiting, having started on 1 July 2020, with plans to enroll 104 participants. Led by Peking University, it is expected to complete by 1 December 2026. The latest data from ClinicalTrials.gov was last updated on 22 July 2020.
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 after signing informed consentTo evaluate trastuzumab combined with pyrrolitinib and chemotherapy regimen (TCbH+Py) for HER2 positive breastPathologic complete response rate (pCR) for adenocarcinoma.
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 after signing informed consent. This study aims to evaluate trastuzumab The pathological complete response rate (pCR) of anti-combined pyrrotinib and chemotherapy (TCbH+Py) in the treatment of HER2-positive breast cancer.

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Official Title

Trastuzumab Combined With Pyrotinib and Chemotherapy for Locally Advanced, Inflammatory, or Early HER2-positive Mammary glandsCancer: One Arm, Open, Phase II Clinical Study

Conditions
HER2-positive Breast Cancer
Other Study IDs
  • OBU-BC-II-024
NCT ID Number
NCT04481932
Start Date (Actual)
2020-07
Last Update Posted
2020-07-22
Completion Date (Estimated)
2026-12
Enrollment (Estimated)
104
Study Type
Interventional
PHASE
Phase 2
Status
Recruiting
Primary Purpose
Treatment
Design Allocation
N/A
Interventional Model
Single Group
Masking
None (Open Label)
Arms / Interventions
Participant Group/ArmIntervention/Treatment
ExperimentalTrastuzumab combined with Pyrotinib and chemotherapy
The dosage of the above drugs can be adjusted according to the adverse reactions of the subjects. The subject continued to use the drug until the full cycle or the disease progressed or the toxicity was intolerable or withdrawn, or the researcher judged that the medication must be terminated.
Trastuzumab combined with Pyrotinib and chemotherapy
Pyrotinib is a small molecule, irreversible tyrosine kinase inhibitor with targets of epidermal growth factor receptor 1 (EGFR/HER1/ErbB1), human epidermal factor receptor 2 (HER2/ErbB2/Neu) and human epidermis Factor Receptor 4 (HER4/ErbB4). As a new generation of anti-HER2 therapeutic targeted drugs, pirotinib covalently binds to the ATP binding sites of the kinase regions of EGFR, HER2 and HER4 in cells to preven...Show More
Primary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
pathological complete response (pCR)
Breast without invasive carcinoma and carcinoma in situ or only carcinoma in situ (ypT0 or ypT0/is)
From enrollment to 18 weeks
Secondary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
overall survival (OS)
From the date of enrollment to the time of death due to any cause
At least two years
Safety index
ECOG PS score, vital signs, physical examination, laboratory examination indicators, ECG, echocardiography, adverse events (AE) according to NCI-CTC AE 5.0 standard
At least two years
Participation Assistant
Eligibility Criteria

Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
Female
Accepts Healthy Volunteers
Yes
  1. Female between 18 and 70 years old;
  2. Histologically confirmed as invasive breast cancer;
  3. ECOG PS 0-1;
  4. The expected survival time is not less than 12 weeks;
  5. Standard immunohistochemical HER2-positive breast cancer patients (IHC +++ or FISH amplification);
  6. The status of hormone receptors (ER and PR) can be known.
  7. Clinical examination or imaging examination of primary lesion >2cm;
  8. 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);
  9. Echocardiography indicated left ventricular ejection fraction (LVEF)≥55%;
  10. 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;
  11. 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.

  1. Have received any previous anti-tumor treatment for primary invasive breast cancer;
  2. 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
  3. 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);
  4. Metastatic breast cancer (M1), bilateral or ipsilateral multifocal breast cancer;
  5. 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;
  6. Receive other anti-tumor treatments within 4 weeks before enrollment;
  7. Inability to swallow, intestinal obstruction or other factors affecting the use and absorption of medication;
  8. Persons with allergic constitution or known history of allergy to the drug components of the program;
  9. 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;
  10. 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
  11. Other circumstances deemed inappropriate for inclusion by the researcher.
Peking University logoPeking University
Study Responsible Party
Tao OUYANG, Principal Investigator, Chairman of Breast Center of Peking University Cancer Hospital
Study Central Contact
Contact: Tao Ouyang, MD, 88271119-5002, [email protected]
1 Study Locations in 1 Countries

Beijing Municipality

Peking University Cancer Hospital, Beijing, Beijing Municipality, 100142, China
TAO OUYANG, M.D, Contact, 0086-10-88196696, [email protected]
Recruiting