Status:
ACTIVE_NOT_RECRUITING
Treatment of Breast Cancer With Trastuzumab + HS627/ Pertuzumab + Docetaxel
Lead Sponsor:
BioRay Pharmaceutical Co., Ltd.
Conditions:
Breast Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE3
Brief Summary
The trial included screening period (4 weeks) and treatment period (4 treatment cycles, at least 12 weeks).
Detailed Description
A multicenter, randomized, double-blind, positive drug parallel control design was used. The trial included screening period (4 weeks) and treatment period (4 treatment cycles, at least 12 weeks). All...
Eligibility Criteria
Inclusion
- Histologically confirmed invasive breast carcinoma with a primary tumor size of more than (\>) 2 centimeters (cm) by standard local assessment technique；
- Breast cancer stage at presentation: early-stage (T2-3, N0-1, M0), locally advanced (T2-3, N2-3,M0 or T4a-c, any N, M0), or infl ammatory (T4d, any N,M0)；
- Known hormone receptor status (estrogen receptor and/or progesterone receptor)；
- HER2 positive (HER2+++ by IHC or ISH+).
- Baseline left ventricular ejection fracture \>= 55% measured by echocardiography (preferred) or multiple gated acquisition scan；
- Normalities in liver, kidney or hematologic function laboratory tests immediately prior to randomization;
- Absolute value of neutrophils ≥ 1.5 × 109 / L;
- Platelet ≥ 90×109 / L;
- Hemoglobin ≥ 90g / L;
- Serum creatinine≤ 1.5 times the upper limit of normal (ULN);
- Serum total bilirubin≤1.5 times ULN (except for Gilbert syndrome);
- Aspartate aminotransferase (AST) and / or alanine aminotransferase (ALT) ≤ 1.5-fold ULN;
- International normalized ratio (INR), activated partial prothrombin time (APTT) ≤ 1.5 times ULN.
- ECOG≤1；
Exclusion
- Stage IV metastatic ;
- Bilateral breast cancer;
- Previous anti-cancer therapy or radiotherapy for any malignancy;
- History of other malignancy within 5 years, except for appropriately-treated carcinoma in Cervical carcinoma in situ, basal cell carcinoma or squamous cell skin cancer;
- Serious cardiac illness or medical condition;
- HIV antibody positive; HCV antibody positive and HCV RNA positive; HBcAb or HBsAg positive, and HBV DNA positive;
- Sensitivity to any of the study medications, any of the ingredients or excipients of these medications;
- Known mental history had poor compliance;
- Known to have drug abusers;
- Concurrent anti-cancer treatment in another investigational trial, including hormone therapy, bisphosphonate therapy, or immunotherapy;
- Needed intravenous antibiotic treatment due to infection within 7 days before random enrollment;
- Major surgical procedure unrelated to breast cancer within 4 weeks prior to randomization or expected to perform major surgery during the trial period;
- Premenopausal women (menopause is defined as non treatment induced menopause≥12 months) or without surgical sterilization (e.g., ovariectomy and / or uterus): refuse to take one or more effective contraceptive measures during treatment and at least 6 months after the last study treatment; blood pregnancy test is positive; pregnant or lactating women; Considered unsuitable for the study or may not be able to complete the trial due to other reasons.
Key Trial Info
Start Date :
June 28 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2025
Estimated Enrollment :
408 Patients enrolled
Trial Details
Trial ID
NCT04514419
Start Date
June 28 2020
End Date
December 1 2025
Last Update
November 21 2025
Active Locations (1)
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1
The Affiliated Hospital of Qingdao University
Qingdao, Shandong, China, 266000