Status:
ACTIVE_NOT_RECRUITING
Pyrotinib Plus Neoadjuvant Chemotherapy in HR+/HER2-, HER4-High Breast Cancer
Lead Sponsor:
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Collaborating Sponsors:
Jiangsu HengRui Medicine Co., Ltd.
Conditions:
Breast Cancer
Hormone-receptor Positive Breast Cancer
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
This is a Phase II, single-center, double-blind, placebo-controlled, randomized study of Pyrotinib in combination with Doxorubicin/Epirubicin and Cyclophosphamide followed by Docetaxel/nab-Paclitaxel ...
Detailed Description
Pyrotinib is an oral, irreversible pan-ErbB receptor tyrosine kinase inhibitor (TKI) with activity against epidermal growth factor receptor HER1(EGFR), HER2 and HER4. Improvement of the chemotherapy e...
Eligibility Criteria
Inclusion
- Presenting with histological(by core needle biopsy or by limited incisional biopsy) proven hormone receptor positive (ER≥10% and/or PR ≥1%), HER2 negative(IHC ≤2+ and/or FISH-) , stage II/ III breast cancer.
- Have clinical indication for neoadjuvant therapy.
- HER4 IHC score ≥ 4.
- Measurable disease (breast and/or lymph nodes).
- The Eastern Cooperative Oncology Group (ECOG) performance status must be 0 or 1.
- Adequate bone marrow function (within 4 weeks prior to registration): WBC≥3.0x109/l, neutrophils ≥1.5 x 109/l, platelets ≥100 x 109/l.
- Adequate liver function (within 4 weeks prior to registration): bilirubin ≤1.5 x upper limit of normal (UNL) range, ALAT and/or ASAT ≤2.5 x UNL, Alkaline Phosphatase ≤5 x UNL.
- Adequate renal function (within 4 weeks prior to registration): the calculated creatinine clearance should be ≥50 ml/min.
- Patients must have the ability to swallow oral medication.
- Without history of any kind of treatment to known malignancy (solid tumor or hematologic).
- Written informed consent.
- Accessible for treatment and follow-up.
Exclusion
- Evidence of stage IV breast cancer.
- Contralateral invasive breast cancer or Inflammatory breast cancer.
- History of non-breast malignancies (except for in situ cervical cancers, basal cell carcinoma of the skin, squamous cell carcinomas of the skin or thyroid papillary carcinoma that had received curative treatment before enrollment) within 5 years prior to randomization.
- Known metastatic disease from any malignancy (solid tumor or hematologic).
- Serious other diseases as infections (hepatitis B, C and HIV), recent myocardial infarction, clinical signs of cardiac failure or clinically significant arrhythmias or on screening, any of the following cardiac parameters: bradycardia (heart rate \<50 at rest) or QTcF ≥450 msec.
- Known hypersensitivity reaction to any of the components of the treatment.
- Pregnancy or lactation at the time of randomization.
- Medical or psychological condition which in the opinion of the investigator would not permit the patient to complete the study or sign meaningful informed consent.
Key Trial Info
Start Date :
April 20 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2028
Estimated Enrollment :
140 Patients enrolled
Trial Details
Trial ID
NCT04872985
Start Date
April 20 2021
End Date
December 31 2028
Last Update
January 6 2026
Active Locations (1)
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1
Sun-Yat-Sen Memorial Hospital of Sun-Yat-Sen University
Guangzhou, Guangdong, China, 510120