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

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ClinicalTrials.gov Identifier: NCT04514419
Recruitment Status : Recruiting
First Posted : August 17, 2020
Last Update Posted : August 17, 2020
Sponsor:
Information provided by (Responsible Party):
Zhe Jiang Hisun Bioray Bio-pharmaceu tical Co.Ltd

Study Description
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Brief Summary:
The trial included screening period (4 weeks) and treatment period (4 treatment cycles, at least 12 weeks).

Condition or disease Intervention/treatment Phase
Breast Cancer Drug: HS627 Drug: Pertuzumab Phase 3

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 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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 408 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Phase III Study to Compare HS627 vs. Pertuzumab on the Efficacy, Safety and Immunogenicity in Combination With Trastuzumab and Docetaxel as Neoadjuvant Therapy in Patients With Early-stage or Locally Advanced HER2 Positive Breast Cancer
Actual Study Start Date : June 30, 2020
Estimated Primary Completion Date : November 20, 2021
Estimated Study Completion Date : November 20, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arms and Interventions
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Arm Intervention/treatment
Experimental: Trastuzumab + HS627 + Docetaxel
Trastuzumab HS627 Docetaxel
 Drug: HS627
Prior to surgery: trastuzumab, HS627, and docetaxel for 4 cycles (1 cycle = 21 days).
Other Name: Trastuzumab + HS627 + Docetaxel
Experimental: Trastuzumab + Pertuzumab + Docetaxel
Trastuzumab Pertuzumab Docetaxel
 Drug: Pertuzumab
Prior to surgery: trastuzumab, Pertuzumab, and docetaxel for 4 cycles (1 cycle = 21 days).
Other Name: Trastuzumab Pertuzumab Docetaxel


Outcome Measures
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Primary Outcome Measures :
  1. Percentage of participants achieving Pathological Complete Response (pCR) as Assessed by the Independent Review Committee (IRC) [ Time Frame: After surgery (At surgery cycle 4 Days 22-35)(1 cycle = 21 days) ]
    pCR was defined as ypT0/is According to the American Joint Committee on Cancer Staging System as Assessed by the IRC


Secondary Outcome Measures :
  1. Percentage of Participants With Total Pathologic Complete Response (tpCR) as Assessed by the Independent Review Committee (IRC) [ Time Frame: After surgery (At surgery cycle 4 Days 22-35) (1 cycle = 21 days) ]
    tpCR was defined as ypT0/is, ypN0 as assessed by an Independent Review Committee (IRC)

  2. Percentage of Participants With pCR as Assessed by the Local Pathologist [ Time Frame: After surgery (At surgery cycle 4 Days 22-35) (1 cycle = 21 days) ]
    pCR was defined as ypT0/is as assessed by Local Pathologist

  3. Percentage of Participants With Total Pathologic Complete Response (tpCR) as Assessed by the Local Pathologist [ Time Frame: After surgery (At surgery cycle 4 Days 22-35) (1 cycle = 21 days) ]
    tpCR was defined as ypT0/is, ypN0 as assessed by Local Pathologist

  4. Percentage of Participants With an Objective Response [ Time Frame: Prior to surgery (Cycle 4 Days 21) (1 cycle = 21 days) ]
    An objective response was defined as the percentage of participants who achieved a complete response or partial response as the best tumor response during the treatment period (that is, during Cycles 1-4 prior to surgery), as determined by the investigator on the basis of Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.

  5. Percentage of Participants with vital signs, physical examination, left ventricular ejection fraction (LVEF), laboratory examination, adverse events (AE) until last visit [ Time Frame: Last Visit （After surgery 8 days）（After 4 cycles treatment ，After surgery ） (1 cycle = 21 days) ]
    The percentage of participants who experienced at least one vital sign, physical examination, left ventricular ejection fraction (LVEF), laboratory examination, adverse events (AE) during the study is reported here.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04514419


Contacts
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Contact: Anhui Peng, master 18806555071 anhui.peng@hisunbioray.com.cn

Locations
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China, Shandong
The Affiliated Hospital of Qingdao University Recruiting
Qingdao, Shandong, China, 266000
Contact: Anhui Peng, Master    18806555071    anhui.peng@hisunbioray.com.cn   
Principal Investigator: Zefei Jiang, M.D         
Principal Investigator: Haibo Wang, M.D         
Sponsors and Collaborators
Zhe Jiang Hisun Bioray Bio-pharmaceu tical Co.Ltd
Investigators
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Principal Investigator: Zefei Jiang, M.D The Affiliated Hospital of Qingdao University
Principal Investigator: Haibo Wang, M.D The Affiliated Hospital of Qingdao University
More Information
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Responsible Party: Zhe Jiang Hisun Bioray Bio-pharmaceu tical Co.Ltd
ClinicalTrials.gov Identifier: NCT04514419    
Other Study ID Numbers: HS627-III
First Posted: August 17, 2020    Key Record Dates
Last Update Posted: August 17, 2020
Last Verified: August 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Docetaxel
Trastuzumab
 Pertuzumab
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Immunological