Actively Recruiting

Phase 2
Age: 18Years - 70Years
FEMALE
Healthy Volunteers
NCT04481932

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

Led by Peking University · Updated on 2020-07-22

104

Participants Needed

1

Research Sites

334 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years - 70Years
FEMALE
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Female between 18 and 70 years old
  • Histologically confirmed invasive breast cancer
  • Eastern Cooperative Oncology Group performance status (ECOG PS) 0 or 1
  • Expected survival time of at least 12 weeks
  • Confirmed HER2-positive breast cancer (IHC +++ or FISH amplification)
  • Known hormone receptor status (estrogen and progesterone receptors)
  • Primary tumor larger than 2 cm by clinical or imaging exam
  • Operable, locally advanced, or inflammatory breast cancer without prior anti-tumor therapy
  • Left ventricular ejection fraction (LVEF) of 55% or higher by echocardiography
  • Adequate organ and bone marrow function including neutrophil count ≥ 1,500/mm3, platelet count ≥ 100,000/mm3, hemoglobin ≥ 9 g/dL, serum creatinine ≤ 1.5 times upper limit normal or creatinine clearance ≥ 60 ml/min, total bilirubin ≤ 1.5 times upper limit normal, AST/ALT ≤ 2.5 times upper limit normal, urinary protein less than 2+ or quantified protein ≤ 1 g if higher
  • Signed informed consent and willingness to comply with study procedures
Not Eligible

You will not qualify if you...

  • Prior anti-tumor treatment for primary invasive breast cancer
  • Previous or other malignancies within 10 years except certain curable cancers (basal cell or squamous cell skin carcinoma and cervical carcinoma in situ)
  • Metastatic breast cancer or bilateral/multifocal breast cancer
  • Uncontrolled hypertension or significant cardiovascular disease including ischemia, infarction, angina, arrhythmias, heart failure, cerebrovascular events, or poor cardiac function
  • Anti-tumor treatments within 4 weeks prior to enrollment
  • Inability to swallow or absorb medications
  • Allergy to study drug components
  • Severe concomitant illness or conditions unsuitable for participation
  • Female participants of childbearing potential not surgically sterilized must have negative pregnancy tests and not be breastfeeding
  • Other conditions deemed inappropriate by investigators

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Peking University Cancer Hospital

Beijing, Beijing Municipality, China, 100142

Actively Recruiting

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Research Team

T

Tao Ouyang, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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