Not Yet RecruitingPhase 2/3

A Phase II/III Clinical Study to Evaluate the Efficacy and Safety of HLX87in Combination With HLX22 or Pertuzumab in the Neoadjuvant Therapy of HER2-Positive Bresat Cancer

817 participantsStarted 2026-01-27

Plain-language summary

The study is being conducted to evaluate the clinical efficacy of HLX87 in combination with HLX22 or pertuzumab vs. TCbHP in the neoadjuvant therapy of HER2-positive early or locally advanced breast cancer.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Histologically confirmed invasive breast cancer;
. Clinical stage (assessed by mammography or MRI): T0-4 (including inflammatory breast cancer), N1-3, M0; or ≥ T3, N0, M0 (according to AJCC 8th edition);
. HER2-positive as determined by the central laboratory, defined as IHC 3+ or IHC 2+ and ISH-positive;
. For unifocal and multifocal tumors (i.e., more than one tumor, all confined to the same quadrant as the primary tumor), at least 1 lesion should be sampled and confirmed as HER2-positive by the central laboratory;
. For multi-centric tumors (i.e., multiple tumors involving two or more quadrants of the breast), 1 lesion should be sampled from each affected quadrant and confirmed as HER2-positive by the central laboratory, and all tested quadrants must be confirmed as HER2-positive;
. Positive or negative for hormone receptors HR (including estrogen receptor \[ER\] and progesterone receptor \[PgR\]) as determined by the central laboratory.

Exclusion criteria

. Any previous and current heart failure or systolic dysfunction meeting the NYHA criteria;
. High-risk uncontrollable arrhythmia: atrial tachycardia with resting heart rate \> 100 beats/min, significant ventricular arrhythmia (such as ventricular tachycardia), or high-grade atrioventricular block (such as Mobitz II second-degree atrioventricular block or third-degree atrioventricular block);

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

• Total pathologic complete response (tpCR) rate

Timeframe: up to 24 weeks

Trial details

NCT IDNCT07294534

SponsorShanghai Henlius Biotech

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2028-09-30

Contact for this trial

Even Yi, Dr

021-33395800 Yiwen_YI@henlius.com

View on ClinicalTrials.gov More HER2 + Breast Cancer trials