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

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

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

Study Overview

• Status: Unknown
• Conditions: Breast Cancer
• Intervention / Treatment: Drug: HS627; Drug: Pertuzumab

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 Type: Interventional
• Enrollment (Anticipated): 408
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Anhui Peng, master; Phone Number: 18806555071; Email: anhui.peng@hisunbioray.com.cn

Study Locations

• China
  • Shandong
    • Qingdao, Shandong, China, 266000
      • Recruiting
      • The Affiliated Hospital of Qingdao University
      • Contact: Anhui Peng, master; Phone Number: 18806555071; Email: anhui.peng@hisunbioray.com.cn
      • Principal Investigator: Zefei Jiang, M.D
      • Principal Investigator: Haibo Wang, M.D

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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 Names: 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 Names: Trastuzumab Pertuzumab Docetaxel

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants With Total Pathologic Complete Response (tpCR) as Assessed by the Independent Review Committee (IRC)	tpCR was defined as ypT0/is, ypN0 as assessed by an Independent Review Committee (IRC)	After surgery (At surgery cycle 4 Days 22-35) (1 cycle = 21 days)
Percentage of Participants With pCR as Assessed by the Local Pathologist	pCR was defined as ypT0/is as assessed by Local Pathologist	After surgery (At surgery cycle 4 Days 22-35) (1 cycle = 21 days)
Percentage of Participants With Total Pathologic Complete Response (tpCR) as Assessed by the Local Pathologist	tpCR was defined as ypT0/is, ypN0 as assessed by Local Pathologist	After surgery (At surgery cycle 4 Days 22-35) (1 cycle = 21 days)
Percentage of Participants With an Objective Response	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.	Prior to surgery (Cycle 4 Days 21) (1 cycle = 21 days)
Percentage of Participants with vital signs, physical examination, left ventricular ejection fraction (LVEF), laboratory examination, adverse events (AE) until last visit	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.	Last Visit （After surgery 8 days）（After 4 cycles treatment ，After surgery ） (1 cycle = 21 days)

Collaborators and Investigators

• Sponsor: Zhe Jiang Hisun Bioray Bio-pharmaceu tical Co.Ltd
• Investigators: Principal Investigator: Zefei Jiang, M.D, The Affiliated Hospital of Qingdao University; Principal Investigator: Haibo Wang, M.D, The Affiliated Hospital of Qingdao University

Study record dates

Study Major Dates

• Study Start (Actual): June 30, 2020
• Primary Completion (Anticipated): November 20, 2021
• Study Completion (Anticipated): November 20, 2021

Study Registration Dates

• First Submitted: July 30, 2020
• First Submitted That Met QC Criteria: August 12, 2020
• First Posted (Actual): August 17, 2020

Study Record Updates

• Last Update Posted (Actual): August 17, 2020
• Last Update Submitted That Met QC Criteria: August 12, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Antineoplastic Agents, Immunological; Docetaxel; Trastuzumab; Pertuzumab
• Other Study ID Numbers: HS627-III

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No