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New hope for HER2+ breast cancer: Real-World study tests daily pill pyrotinib

NCT ID NCT06495541

Disease control Sponsor: Tianjin Medical University Cancer Institute and Hospital 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 This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study will follow 500 people with HER2-positive advanced breast cancer who are starting treatment with pyrotinib, a daily oral targeted therapy. Researchers want to see how well the drug controls the cancer and what side effects occur in everyday medical practice, not just in a strict clinical trial. The main goal is to measure how long the cancer stays under control before it progresses.

What this could mean

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

Active substance
Pyrotinib (a targeted cancer drug taken as a daily pill)
What this could lead to
If successful, this could confirm pyrotinib as an effective first-line treatment for HER2-positive advanced breast cancer, potentially improving progression-free survival.
What could go wrong
This is an observational real-world study, not a randomized controlled trial, so results may be less definitive. Side effects of pyrotinib include diarrhea and other toxicities, and the drug may not work for all patients.

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

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 500 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Apr 2026

An estimate. Start dates often move.

Expected to finish

Jul 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

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: 1. Age ≥ 18 years old; 2. Pathological or histopathological confirmed HER2 positive cases cannot be surgically advanced or metastasized Patients with sexual breast cancer (HER2 positive is defined as: standard immunohistochemistry (IHC) Detected as 3+or ISH positive); 3. There is a traceable medical history record during the treatment period; 4. Voluntarily participate in this study, sign informed consent, have good compliance, and are willing to cooperate Follow up. Exclusion Criteria: 1. Failure to sign informed consent form; 2. Previous history of other malignant tumors, but cured skin basal cell carcinoma and cervical cancer Excluding cancer; 3. Difficulty in swallowing, chronic diarrhea, and intestinal obstruction, which can affect medication administration and absorption Various factors; 4. Pregnant or lactating women, and women of childbearing age who cannot achieve optimal contraception; 5. Any other circumstances in which the researcher deems the patient unsuitable to participate in this study.

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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 Pyrotinib RWS

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  2. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

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