Treatment of Breast Cancer With Trastuzumab + HS627/ Pertuzumab + Docetaxel

• Status: Recruiting
• Trial end date: 2021-11-20
• Target enrollment: 0
• Participant gender: Female

Summary

The trial included screening period (4 weeks) and treatment period (4 treatment cycles, at least 12 weeks).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Zhe Jiang Hisun Bioray Bio-pharmaceu tical Co.Ltd
• Treatments: Docetaxel; Pertuzumab; Trastuzumab

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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.