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Can Real-World data unlock better breast cancer treatment sequences?

NCT ID NCT07743944

Knowledge-focused Sponsor: AstraZeneca 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 04, 2026 · Last updated Aug 05, 2026 · Updated 1 time

Summary

This study is a large registry that will follow about 2,000 adults in China with a type of advanced breast cancer called HR+/HER2- (including HER2-low, HER2-ultralow, and HER2-null). The goal is to describe the patients' characteristics, genetic testing, treatment patterns, and outcomes across different lines of therapy. It will also track quality of life and healthcare costs. By observing what happens in everyday practice, researchers hope to understand which treatment approaches are most effective and how to improve care.

What this could mean

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

What this could lead to
This registry could help identify which treatment sequences work best for HR+/HER2- metastatic breast cancer in real-world settings, potentially guiding more personalized and effective care.
What could go wrong
As an observational registry, it cannot prove cause and effect. Results may be influenced by patient selection and real-world variability, and may not apply to other populations.

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.

Participants

About 2,000 people

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

Expected to start

Aug 2026

An estimate. Start dates often move.

Expected to finish

Aug 2031

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.

Who is studied

The study population includes Chinese adult patients with HR+/HER2- (including HER2-low, HER2-ultralow, and HER2-null) unresectable or metastatic breast cancer who are about to initiate 2L systemic therapy or initiated 2L systemic therapy within 2 months at participating sites.

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 \* Must be competent and able to comprehend, sign, and date an Institutional Review Board or Institutional Ethics Committee approved Informed consent form (ICF) before participating in the study. OR Eligible for exemption from informed consent (for patients who die or became lost to follow-up within 2 months of initiating 2L therapy). \* Chinese men or women ≥ 18 years old at time of consent. \* Pathologically documented breast cancer that: a) is unresectable or metastatic. b) is HR+/HER2- (IHC 2+/ISH- or IHC 1+ or IHC 0, with/without membrane staining) based on the most recent test result \* Planning to initiate 2L treatment or initiated 2L systemic therapy within 2 months prior enrollment as per the prescription or medical records. Exclusion Criteria \* Patients who plan to participate in any blinded interventional clinical trial in 2L setting.

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Conditions

The condition(s) this trial relates to.

breast cancer breast neoplasm hormone receptor-positive breast cancer

As listed by the trial registrant

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

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

  • The First Affiliated Hospital of Nanjing Medical University (Jiangsu Province Hospital)

    RECRUITING

    Nanjing, Jiangsu, 210029, China

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