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

NCT04514419 | Active Not Recruiting Phase 3

• 1 other identifier: HS627-III
• Study Type: interventional
• Target: 408
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Percentage of Participants With Total Pathologic Complete Response (tpCR) as Assessed by the 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

  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

  After surgery (At surgery cycle 4 Days 22-35) (1 cycle = 21 days)

• Percentage of Participants With an Objective Response

  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

  Last Visit （After surgery 8 days）（After 4 cycles treatment ，After surgery ） (1 cycle = 21 days)

Study Arms (2)

Trastuzumab + HS627 + Docetaxel

EXPERIMENTAL

Trastuzumab HS627 Docetaxel

Drug: HS627

Trastuzumab + Pertuzumab + Docetaxel

EXPERIMENTAL

Trastuzumab Pertuzumab Docetaxel

Drug: Pertuzumab

Interventions

HS627 DRUG

Prior to surgery: trastuzumab, HS627, and docetaxel for 4 cycles (1 cycle = 21 days).

Also known as: Trastuzumab + HS627 + Docetaxel

Trastuzumab + HS627 + Docetaxel

Pertuzumab DRUG

Prior to surgery: trastuzumab, Pertuzumab, and docetaxel for 4 cycles (1 cycle = 21 days).

Also known as: Trastuzumab Pertuzumab Docetaxel

Trastuzumab + Pertuzumab + Docetaxel

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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；

You may not qualify if:

• 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.

Sponsors & Collaborators

• BioRay Pharmaceutical Co., Ltd.: lead

Study Sites (1)

The Affiliated Hospital of Qingdao University

Qingdao, Shandong, 266000, China

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Trastuzumab; Docetaxel; pertuzumab

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes

Study Officials

• Zefei Jiang, M.D

  The Affiliated Hospital of Qingdao University

  PRINCIPAL INVESTIGATOR

• Haibo Wang, M.D

  The Affiliated Hospital of Qingdao University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 30, 2020
• First Posted: August 17, 2020
• Study Start: June 28, 2020
• Primary Completion: September 11, 2024
• Study Completion: December 1, 2025
• Last Updated: November 21, 2025

Record last verified: 2025-11

Locations

CN (1)