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Can a new pill keep HER2-Positive breast cancer from coming back?

NCT ID NCT03980054

Disease control Sponsor: Jiangsu HengRui Medicine Co., Ltd. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 17, 2026 · Last updated Aug 18, 2026 · Updated 1 time

Summary

This phase III trial is testing whether the drug pyrotinib can further reduce the risk of breast cancer returning in women with HER2-positive early or locally advanced breast cancer who have already completed standard treatment with trastuzumab. Participants will be randomly assigned to receive either pyrotinib or a placebo once daily for one year. The study aims to see if pyrotinib improves the time without invasive cancer recurrence or death.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
pyrotinib
What this could lead to
If successful, pyrotinib could offer a new way to reduce the chance of breast cancer returning in high-risk patients who have already received standard treatment.
What could go wrong
This is a large, late-stage trial, but results are not yet known. Pyrotinib may not prove more effective than placebo, and it could have side effects that outweigh its benefits.

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

2,135 people

The number who actually took part.

Started

Jul 2019

Expected to finish

Jun 2027

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

18 to 75 years

Sex

Female participants only

Healthy volunteers

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

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Female patients, 18 years ≤ age ≤ 75 years； * Performance Status- Eastern Cooperative Oncology Group (ECOG) 0-1 * Histologically confirmed invasive HER2 positive breast cancer. * Known hormone receptor status. * Cardiovascular: Baseline left ventricular ejection fraction (LVEF)≥55% measured by Echocardiogram. * Been treated for early breast cancer with standard of care duration of trastuzumab. * If been not treated neoadjuvantly, lymph node metastases need to be confirmed by postoperative pathology; if been treated neoadjuvantly , have not reached totally pathologic complete response. * Signed informed consent form (ICF) . Exclusion Criteria: * Positive clinical and radiologic assessments for local or regional recurrence of disease at the time of study entry. * History of heart disease. * Bilateral breast cancer. * Corrected QT (QTc) interval ≥0.47 seconds. * History of gastrointestinal disease with diarrhea as the major symptom.

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Conditions

The condition(s) this trial relates to.

breast cancer breast neoplasm HER2 positive breast carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Breast cancer

Contacts and locations

Locations

  • Fudan University Cancer Hospital

    Shanghai, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.