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

  • STATUS
    Recruiting
  • End date
    Nov 20, 2021
  • participants needed
    408
  • sponsor
    Zhe Jiang Hisun Bioray Bio-pharmaceu tical Co.Ltd
Updated on 25 January 2021
estrogen
carcinoma
progesterone
pertuzumab
HER2
primary tumor
docetaxel
trastuzumab
progesterone receptor
erbb2
estrogen receptor
breast carcinoma
invasive breast cancer
breast cancer staging

Summary

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

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 eligible subjects were randomly divided into experimental group (hs627 treatment group) and control group (pertuzumab) treatment group. After 4 treatment cycles, the subjects arranged surgical treatment, and then conducted the last visit.

Details
Condition Breast Cancer, Breast Cancer Diagnosis, breast carcinoma, cancer, breast
Treatment Pertuzumab, HS627
Clinical Study IdentifierNCT04514419
SponsorZhe Jiang Hisun Bioray Bio-pharmaceu tical Co.Ltd
Last Modified on25 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age greater than or equal to 18 yrs?
Are you female?
Do you have Breast Cancer?
Do you have any of these conditions: cancer, breast or Breast Cancer Diagnosis or Breast Cancer or breast carcinoma?
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 90109 / L
Hemoglobin 90g / L
Serum creatinine 1.5 times the upper limit of normal (ULN)
Serum total bilirubin1.5 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
ECOG1

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 menopause12 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
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