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New biosimilar aims to match pertuzumab in breast cancer fight
NCT ID NCT04514419
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This phase 3 trial tests whether a new drug called HS627 (a biosimilar) works as well as pertuzumab when given with trastuzumab and docetaxel before surgery for HER2-positive breast cancer. About 408 people with early-stage or locally advanced breast cancer took part. The main goal is to see if the cancer completely disappears in the breast tissue after treatment.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- HS627 (a biosimilar to pertuzumab)
- What this could lead to
- If it works, this could offer a more affordable or equally effective alternative to pertuzumab for treating HER2-positive breast cancer before surgery.
- What could go wrong
- This is a phase 3 trial, but it's comparing a biosimilar to an established drug. The biosimilar may not prove as effective or safe, and results may not apply to all breast cancer types.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
-
About 408 people
The number the study aims to enrol. It can still change while the study runs.
- Started
-
Jun 2020
- Expected to finish
-
Dec 2025
An estimate. End dates often move.
- Lead sponsor
-
A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Female participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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The Affiliated Hospital of Qingdao University
Qingdao, Shandong, 266000, China
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Other studies related to the condition(s) this trial covers.
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