Trastuzumab Combined With Pyrrolidine and Chemotherapy for Locally HER2 Positive Breast Cancer

NCT04481932 | Recruiting Phase 2

• 1 other identifier: OBU-BC-II-024
• Study Type: interventional
• Target: 104
• Locations: 1 country
• Sites: 1

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.

Conditions

HER2-positive Breast Cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• overall survival (OS)

  At least two years

• Safety index

  At least two years

Study Arms (1)

Trastuzumab combined with Pyrotinib and chemotherapy

EXPERIMENTAL

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The subject continued to use the drug until the full cycle or the disease progressed or the toxicity was intolerable or withdrawn, or the researcher judged that the medication must be terminated.

Drug: Trastuzumab combined with Pyrotinib and chemotherapy

Interventions

Trastuzumab combined with Pyrotinib and chemotherapy DRUG

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 prevent homogeneity and heterogeneity of EGFR, HER2 and HER4 in tumor cells Dimer formation, inhibiting its own phosphorylation, blocking the activation of downstream signaling pathways, thereby inhibiting tumor cell growth

Trastuzumab combined with Pyrotinib and chemotherapy

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Peking University: lead

Study Sites (1)

Peking University Cancer Hospital

Beijing, Beijing Municipality, 100142, China

RECRUITING

MeSH Terms

Interventions

pyrotinib; Drug Therapy

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Tao Ouyang, MD

  Peking University Cancer Hospital & Institute

  STUDY CHAIR

Central Study Contacts

Tao Ouyang, MD

CONTACT

88271119-5002; ouyanghongtao@263.net

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chairman of Breast Center of Peking University Cancer Hospital

Study Record Dates

• First Submitted: July 13, 2020
• First Posted: July 22, 2020
• Study Start: July 1, 2020
• Primary Completion: June 1, 2022
• Study Completion (Estimated): December 1, 2026
• Last Updated: July 22, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)