Actively Recruiting
Pyrotinib Combined With Trastuzumab, Dalpiciclib, Letrozole Versus TCbHP (Trastuzumab Plus Pertuzumab With Docetaxel and Carboplatin) as Neoadjuvant Treatment in HR +/HER2 + Breast Cancer
Led by Shengjing Hospital · Updated on 2023-03-20
236
Participants Needed
1
Research Sites
259 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is an investigator-initiated randomized controlled, open-label, multicenter, prospective Phase 2 clinical study. Patients with stage II-III HR +/HER2 + breast cancer were randomly divided into two groups at a ratio of 1:1. The experimental group received pyrotinib combined with trastuzumab, dalpiciclib and letrozole; the control group received trastuzumab combined with pertuzumab, docetaxel and carboplatin. The main study objective was to evaluate the efficacy and safety of neoadjuvant therapy for HR +/HER2 + breast cancer in the two groups.
CONDITIONS
Official Title
Pyrotinib Combined With Trastuzumab, Dalpiciclib, Letrozole Versus TCbHP (Trastuzumab Plus Pertuzumab With Docetaxel and Carboplatin) as Neoadjuvant Treatment in HR +/HER2 + Breast Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female patients aged 18 to 75 years
- Willing to receive LHRH agonist therapy if premenopausal
- Diagnosed with estrogen receptor-positive and HER2-positive breast cancer confirmed by pathology
- Treatment-nafve stage II-III breast cancer meeting AJCC version 8 criteria
- ECOG performance status 0 or 1
- Adequate organ function including bone marrow, liver, kidney, heart function, and ECG within specified limits
- Able to undergo needle biopsy
- Voluntarily agree to participate, sign informed consent, and comply with follow-up
You will not qualify if you...
- Prior anti-tumor therapy such as chemotherapy, radiotherapy, targeted therapy, or endocrine therapy
- Receiving other anti-tumor therapies concurrently
- Bilateral, inflammatory, or occult breast cancer
- Stage IV breast cancer
- Breast cancer without pathological diagnosis
- Other malignancies within 5 years except certain cured skin or cervical cancers
- Severe dysfunction of heart, liver, kidney, or other vital organs
- Conditions affecting drug absorption such as inability to swallow or chronic diarrhea
- Participation in other drug trials within 4 weeks before enrollment
- History of hypersensitivity to study drugs or immunodeficiency including HIV, HCV, active hepatitis B, or organ transplant
- Significant cardiac disease including arrhythmia needing medication, myocardial infarction, heart failure, or other investigator-judged cardiac issues
- Pregnancy, lactation, positive pregnancy test, or unwillingness to use effective contraception
- Serious concomitant diseases that may affect safety or study completion
- History of neurological or psychiatric disorders including epilepsy or dementia
- Any condition deemed inappropriate by the investigator for participation
AI-Screening
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Trial Site Locations
Total: 1 location
1
Shengjing Hospital of China Medical University
Shenyang, Liaoning, China, 110004
Actively Recruiting
Research Team
N
Nan Niu
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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