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Researchers sift through data to uncover hidden breast cancer subtype

NCT ID NCT06131424

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 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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 26, 2026

Summary

This study reviewed medical records of over 1,100 people with a type of breast cancer called HER2-negative that had spread and stopped responding to treatment. Researchers wanted to find out how many of these patients actually have a subtype called HER2-low, and to understand their characteristics, treatments, and outcomes. The goal was to gather information, not to test a new treatment.

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

1,151 people

The number who actually took part.

Started

Apr 2024

Finished

May 2025

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

Eligible patients from sites will be selected in a consecutive manner ie, patients with dates closest to but on or after 01 January 2019 will be selected first.

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. Men or women, ≥18 years of age 2. Provision of informed consent by the patient or next of kin/legal representative (for deceased patients at study entry, unless a waiver was granted) according to local regulations 3. Must have a histological or cytological confirmed previous diagnosis as HER2-negative (IHC zero, 1+, 2+/ISH-) locally-advanced or mBC between 01 January 2019 and 31 December 2022, regardless of HR status 4. Must have progressed on any systemic anticancer therapy (eg, ET, chemotherapy, CDK4/6 inhibitor, targeted therapies other than anti-HER2, or immunotherapy) in the metastatic setting with the availability of at least 12 months of follow-up data (from the index date) in the medical records at the participating site, unless patient died within the first 12 months of diagnosis a) The HR positive patients will be considered eligible for the study if they have received ET as adjuvant therapy in the early BC setting and progressed within 24 months, this scenario will be considered as progression on systematic treatment in the advanced or metastatic setting 5. Must have historical IHC-stained FFPE tissue from locally-advanced or mBC slides for HER2 in an acceptable quality to allow for accurate rescoring of HER2 expression - Exclusion Criteria:1. Have a history of other malignancies, other than basal cell carcinoma of the skin and squamous cell carcinoma of the skin until 3 years prior to diagnosis of locally-advanced or mBC 2. Patients with historical HER2 status of IHC 2+/ISH+ or 3+, or HER2 amplified \-

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Conditions

The condition(s) this trial relates to.

breast neoplasm Her2-receptor negative breast cancer

As listed by the trial registrant

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

HER2-negative

Contacts and locations

Locations

  • Research Site

    Rosario, Argentina

  • Research Site

    São Paulo, Brazil

  • Research Site

    Santo Domingo, Dominican Republic

  • Research Site

    Hong Kong, Hong Kong

  • Research Site

    Bengaluru, Karnataka, 560017, India

  • Research Site

    Kochi, Kerala, 682041, India

  • Research Site

    Mumbai, Maharashtra, 400012, India

  • Research Site

    Bhubaneswar, Odisha, 751003, India

  • Research Site

    Mohali, Punjab, 160055, India

  • Research Site

    Hyderabad, Telangana, 500034, India

  • Research Site

    Varanasi, Uttar Pradesh, 221005, India

  • Research Site

    Delhi, 110005, India

  • Research Site

    Delhi, 110029, India

  • Research Site

    Delhi, 110085, India

  • Research Site

    Jakarta, Indonesia

  • Research Site

    Kaula Lumpur, 47500, Malaysia

  • Research Site

    Subang Jaya, 47500, Malaysia

  • Research Site

    Subang Jaya, 59100, Malaysia

  • Research Site

    Mexico City, Mexico

  • Research Site

    Panama City, Panama

  • Research Site

    Quezon City, 1112, Philippines

  • Research Site

    Singapore, 168583, Singapore

  • Research Site

    Singapore, 229899, Singapore

  • Research Site

    Singapore, 258499, Singapore

  • Research Site

    Singapore, 308433, Singapore

  • Research Site

    Bangkok, 10330, Thailand

  • Research Site

    Bangkok, 10400, Thailand

  • Research Site

    Bangkok, 10700, Thailand

  • Research Site

    Hanoi, Vietnam

  • Research Site

    Ho Chi Minh City, Vietnam

  • Research Site

    Huế, Vietnam

More trials for these conditions

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