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New model aims to predict who will respond to breast cancer immunotherapy

NCT ID NCT06833723

Knowledge-focused Sponsor: Hangzhou Institute of Medicine (HIM), Chinese Academy of Sciences 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 2 times

Summary

This study looks at tumor and blood samples from 1,000 breast cancer patients who received immunotherapy. Researchers will analyze the samples using advanced techniques to build a model that predicts whether a patient will respond to treatment. No new drugs are tested; the goal is to improve how doctors choose treatments.

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
If successful, this could help doctors predict which breast cancer patients will benefit from immunotherapy, avoiding ineffective treatments.
What could go wrong
This is an observational study using existing data, not a treatment trial. The model may not be accurate enough for real-world use.

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 1,000 people

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

Started

Apr 2025

Expected to finish

Nov 2027

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.

Who is studied

Study Population Description: The study population consists of female breast cancer patients who received or are expected to receive immunotherapy/neoadjuvant immunotherapy at our institution. The study is divided into two cohorts: Retrospective Cohort (2015-2023): Includes patients who received immunotherapy/neoadjuvant immunotherapy between January 1, 2015, and September 30, 2023. Prospective Cohort (2023-Present): Includes patients who may receive immunotherapy/neoadjuvant immunotherapy starting from October 1, 2023. All participants are female, aged ≥ 18 years, and able to provide sufficient tumor tissue samples, blood samples, and imaging data.

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: \- Female, aged ≥ 18 years. Pathologically confirmed diagnosis of breast cancer. Patients who received immunotherapy/neoadjuvant immunotherapy at our institution between January 1, 2015, and September 30, 2023 (retrospective cohort), or patients who may receive immunotherapy/neoadjuvant immunotherapy starting from October 1, 2023 (prospective cohort). Availability of sufficient tumor tissue samples (e.g., fresh biopsy tissue, residual tumor tissue post-surgery). Availability of blood samples and imaging data. Signed informed consent (for the prospective cohort). Exclusion Criteria: * Male breast cancer patients. Inability to provide sufficient tumor tissue samples or other clinical data. Presence of severe comorbidities (e.g., active infections, severe cardiac, hepatic, or renal dysfunction) that may affect the safety assessment of immunotherapy. Lack of signed informed consent (for the prospective cohort).

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Conditions

The condition(s) this trial relates to.

breast cancer breast neoplasm

As listed by the trial registrant

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

Breast neoplasms

Contacts and locations

Locations

  • Zhejiang Cancer Hospital

    Hangzhou, Zhejiang, China

More trials for these conditions

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