Actively Recruiting
Neoadjuvant Treatment Pegylated Liposomal Doxorubicin Plus Cyclophosphamide Sequential Docetaxel Plus Trastuzumab and Pertuzumab Versus Docetaxel Plus Carboplatin Combined With Trastuzumab and Pertuzumab in HER-2 Positive Breast Cancer
Led by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University · Updated on 2024-02-02
372
Participants Needed
1
Research Sites
319 weeks
Total Duration
On this page
Sponsors
S
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Lead Sponsor
C
CSPC Ouyi Pharmaceutical Co., Ltd.
Collaborating Sponsor
AI-Summary
What this Trial Is About
This is a multicenter, open label, non-inferiority, randomized controlled clinical study. The aim of this study is to evaluate the efficacy and safety of a pegylated liposomal doxorubicin + cyclophosphamide followed by docetaxel plus trastuzumab and pertuzumab (PLD + C + HP followed by THP) regimen compared with a docetaxel + carboplatin plus trastuzumab and pertuzumab (TCbHP) regimen in the neoadjuvant treatment of HER-2-positive breast cancer.
CONDITIONS
Official Title
Neoadjuvant Treatment Pegylated Liposomal Doxorubicin Plus Cyclophosphamide Sequential Docetaxel Plus Trastuzumab and Pertuzumab Versus Docetaxel Plus Carboplatin Combined With Trastuzumab and Pertuzumab in HER-2 Positive Breast Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female patients aged from 18 to 70 years old
- Histologically confirmed invasive breast cancer without previous treatment
- HER-2 Positive status confirmed by IHC 3+ or ISH positive
- Tumor size greater than 2 cm
- Regional lymph node metastasis diagnosed by biopsy within 28 days prior to randomization
- At least one measurable disease according to RECIST 1.1
- Multifocal tumors in the same breast quadrant are eligible if all lesions are HER2 positive
- Operable breast cancer with clinical stage cT2-cT4, cN1-cN3, cM0 according to AJCC 8th Edition
- Known hormone receptor (ER and PR) status and Ki-67 expression level
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Left ventricular ejection fraction (LVEF) of 55% or higher
- Normal brain natriuretic peptide (BNP) or N-terminal pro brain natriuretic peptide (NT proBNP) and cardiac troponin levels
- Liver function tests (ALT, AST, ALP, bilirubin) at or below 2 times the upper limit of normal (ULN)
- Serum creatinine at or below 1.5 times ULN
- Adequate bone marrow function with specified minimum blood counts
- Good compliance and understanding of study procedures with signed informed consent
You will not qualify if you...
- Breast cancer with distant metastasis
- Multiple lesions in different breast quadrants or bilateral breast cancer
- Prior anti-cancer therapy for breast cancer except surgically managed LCIS or DCIS treated with mastectomy over 5 years ago
- Severe cardiac disease or discomfort including uncontrolled arrhythmias, angina, significant valvular disease, myocardial infarction, uncontrolled hypertension, or congestive heart failure
- Serious neurological or psychiatric disorders preventing informed consent
- Active uncontrolled infection, active peptic ulcer, or unstable diabetes
- History of other malignancies within 5 years except treated carcinoma in situ of cervix or basal cell carcinoma of skin
- Treatment with investigational drugs within 28 days prior to randomization
- Known allergy to study treatments or contraindications for surgery
- Pregnancy, breastfeeding, or refusal to use adequate contraception
- Judged unsuitable for study participation by investigator
AI-Screening
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Trial Site Locations
Total: 1 location
1
Sunyat-sen Memorial Hospital
Guandong, Guangdong, China
Actively Recruiting
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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