Actively Recruiting
Efficacy and Safety of Pyrotinib Maleate Combined With ARX788 Neoadjuvant Treatment in Breast Cancer Patients
Led by Shengjing Hospital · Updated on 2022-09-13
30
Participants Needed
1
Research Sites
315 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Next-generation Site-specific human epidermal growth factor receptor 2 (HER2)-targeting Antibody-drug Conjugate (ARX788) is an antibody-conjugated drug. Results from the phase I safety, tolerability and pharmacokinetic trial of ARX788 single drug in Chinese patients with advanced HER2 breast cancer indicated a good safety of the test drug, and responses to anti-tumor therapy were observed in the target dose group. Phase II clinical trial is being carried out gradually. This trial is designed to observe the effectiveness and safety of pyrotinib maleate combined with ARX788 neoadjuvant treatment in stage II-III HER2-positive breast cancer patients experiencing a poor efficacy of trastuzumab and pertuzumab.
CONDITIONS
Official Title
Efficacy and Safety of Pyrotinib Maleate Combined With ARX788 Neoadjuvant Treatment in Breast Cancer Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female patients aged 18 to 75 years
- Histologically confirmed invasive breast cancer at stage II-III
- HER2-positive breast cancer confirmed by IHC3+ or FISH+
- Have received neoadjuvant therapy with trastuzumab and pertuzumab and assessed as stable disease (0-20% increase), disease progression, inoperable or not meeting breast-conserving criteria
- Eastern Cooperative Oncology Group (ECOG) score of 0 or 1
- Adequate organ function as defined by blood counts, liver and kidney tests, cardiac function, and ECG parameters
- Able to receive needle biopsy
- Willing to participate voluntarily and comply with study follow-up
You will not qualify if you...
- Receiving other anti-tumor therapies concurrently
- Having bilateral breast cancer, inflammatory breast cancer, or occult breast cancer
- History of other malignancies within the past 5 years except certain cured cancers
- Inability to swallow or gastrointestinal conditions affecting drug absorption
- Cardiac insufficiency or significant heart disease, abnormal QTc interval
- Uncontrolled high blood pressure
- Severe or uncontrolled systemic diseases affecting major organs
- Pregnancy, lactation, or unwillingness to use contraception during the study
- Serious diseases or comorbidities that risk patient safety or study completion
- Allergies to ARX788 or related proteins, or history of severe allergic reactions
- History or evidence of pulmonary interstitial disease requiring treatment
- Current active eye diseases needing intervention
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Shengjing Hospital affiliated to China Medical University
Shenyang, Liaoning, China, 110004
Actively Recruiting
Research Team
N
Nan Niu, 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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