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Immune cell clues in breast cancer tumors may predict Long-Term survival

NCT ID NCT07545434

Knowledge-focused Sponsor: Hellenic Cooperative Oncology Group Source: ClinicalTrials.gov ↗

What the study statuses mean

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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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study examined tumor samples from 3,646 women with early-stage breast cancer who had already received chemotherapy after surgery. Researchers measured specific immune cells (tumor-infiltrating lymphocytes and CD8+ T cells) to see if their presence was linked to how long patients lived without their cancer returning. The goal was to better understand the role of the immune system in fighting breast cancer and potentially improve risk prediction.

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 analysis could help doctors better predict which early breast cancer patients are at higher risk of recurrence, guiding more personalized treatment decisions.
What could go wrong
This is an observational analysis of existing data, not a test of a new treatment. The findings may not change current practice without further validation in prospective studies.

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

3,646 people

The number who actually took part.

Started

Dec 1996

Finished

Mar 2025

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

Caucasian women, with high-risk early breast cancer.The majority of patients were of Greek origin and had intermediate- to high-risk eBC. Furthermore, this study includes long-term survival data with more than 10 years of follow-up.

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: * Women older than 18 years with high-risk, operable eBC. * Histologically confirmed BC * All treated with adjuvant dose-dense sequential chemotherapy (dds-CT). * Tumor tissue specimen (FFPE) availability. Exclusion Criteria: * Lack of FFPE samples. * Bilateral disease. * Distal metastases. * Administration of different chemotherapeutic regimens. * Previous primary cancers.

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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.

Early breast cancer

Contacts and locations

Locations

  • Hellenic Cooperative Oncology Group

    Athens, 11526, Greece

More trials for these conditions

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