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New study tests targeted pill combo for advanced breast cancer in Real-World settings

NCT ID NCT07600164

Disease control Sponsor: Peking University People's Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jul 14, 2026 · Updated 2 times

Summary

This study will follow 500 people with advanced HER2-positive breast cancer who are receiving pyrotinib (a daily pill) as their first or second treatment. Researchers want to see how well the drug works in real life and whether switching to another targeted therapy (Trastuzumab Rezetecan) after the cancer progresses is safe and effective. The study is not yet recruiting and will run at multiple hospitals in China.

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 pill) and Trastuzumab Rezetecan (an antibody-drug conjugate given by IV)
What this could lead to
If successful, this could confirm that pyrotinib works well in everyday practice and that switching to Trastuzumab Rezetecan after progression is a good strategy for advanced HER2+ breast cancer.
What could go wrong
This is a real-world study, not a controlled trial, so results may be less reliable. Side effects from the drugs can include diarrhea, nausea, and low blood cell counts. The study hasn't started yet, so outcomes are uncertain.

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 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 500 people

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

Started

Jul 2026

Expected to finish

Dec 2031

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

Anyone

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. Aged ≥ 18 years old; 2. Histopathologically confirmed HER2-positive inoperable locally advanced or metastatic breast cancer; 3. Patients with first-line or second-line advanced disease: First-line advanced disease: no prior systemic therapy for locally advanced or metastatic disease. For patients who received neoadjuvant or adjuvant therapy, the disease-free interval (DFI) after the completion of the last chemotherapy or HER2-targeted therapy was more than 12 months; Second-line advanced disease: prior treatment with taxane combined with trastuzumab, with or without pertuzumab, in the advanced setting; or recurrence occurring during neoadjuvant/adjuvant therapy, or a disease-free interval (DFI) of ≤ 12 months after completion of the last neoadjuvant/adjuvant chemotherapy and HER2-targeted therapy; 4. Planned to receive pyrotinib-containing regimen, and judged by investigators based on clinical practice to have potential subsequent treatment with Ruikang trastuzumab after failure of pyrotinib-containing therapy; 5. Traceable medical records available throughout the treatment period. Exclusion Criteria: 1. Failure to sign the informed consent form; 2. Pregnant or lactating females; 3. Patients participating in any interventional clinical trial involving investigational drugs or marketed drugs at enrollment; 4. Other conditions deemed ineligible for enrollment by the investigator's judgment.

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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.

Advanced breast cancer HER2 + breast cancer

How to take part

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

  1. The places running it

    1 site. The list below names each one and where it is.

  2. 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 ↗

  3. 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.

Contacts and locations

Locations

  • Peking University People's Hospital

    RECRUITING

    Beijing, Beijing Municipality, 100044, China

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