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Breast CancerPhase 3NCT04514419

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

A Phase 3 study testing HS627 and Pertuzumab in people with Breast Cancer, run by BioRay Pharmaceutical Co., Ltd. at 1 site in China.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

The trial included screening period (4 weeks) and treatment period (4 treatment cycles, at least 12 weeks). Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Breast Cancer
What is being tested?
HS627 and Pertuzumab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
408 participants
Where
1 siteChina
Study dates
28 Jun 2020to Dec 2025
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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;
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  • 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；

Who cannot join

  • 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;
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  • 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.

Trial locations and contacts

1 site in 1 country.

China1 site

  • The Affiliated Hospital of Qingdao University

    Qingdao, Shandong, 266000

Other trials in China

About this study

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

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

Read the 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.

Conditions
Breast Cancer
Being tested
HS627, Pertuzumab
Medical subject headings
Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • HS627Drug

    Also called Trastuzumab + HS627 + Docetaxel

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

  • PertuzumabDrug

    Also called Trastuzumab Pertuzumab Docetaxel

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

Study groups in NCT04514419
Study groupRoleWhat they receive
Trastuzumab + HS627 + DocetaxelExperimentalTrastuzumab HS627 Docetaxel
Receives: Drug: HS627
Trastuzumab + Pertuzumab + DocetaxelExperimentalTrastuzumab Pertuzumab Docetaxel
Receives: Drug: Pertuzumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

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

Secondary outcomes (5)

  1. 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)

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

  2. Percentage of Participants With pCR as Assessed by the Local Pathologist

    pCR was defined as ypT0/is as assessed by Local Pathologist

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

  3. 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

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

  4. 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.

    Measured: Prior to surgery (Cycle 4 Days 21) (1 cycle = 21 days)

  5. 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.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Aug 2020
  2. Study start28 Jun 2020
  3. Primary completion11 Sep 2024
  4. Study completionDec 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
408 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04514419
Sponsor's protocol ID
HS627-III
Status last verified
Nov 2025
First submitted
30 Jul 2020
Last updated
21 Nov 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing HS627 and Pertuzumab in people with Breast Cancer, run by BioRay Pharmaceutical Co., Ltd. at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 14 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 21 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04514419.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Nov 2025.

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