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Scientists investigate rare breast cancer subtype to improve future care

NCT ID NCT07613151

What the study statuses mean

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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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 03, 2026 · Updated 4 times

Summary

This study looks back at medical records of 250 people with a rare type of breast cancer called apocrine lobular carcinoma. Researchers want to understand how this cancer behaves, what treatments patients received, and how they did over time. No new treatments are tested — the goal is to gather information to help doctors better recognize and manage this rare disease.

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 250 people

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

Started

May 2026

Expected to finish

Dec 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

Patients diagnosed between January 1, 2010 and December 31, 2025 will be included. Follow-up will be collected until the most recent available clinical update.

Ages

18 years and older

Sex

Anyone

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 or male patients aged ≥18 years; * Histologically confirmed ILC, confirmed by E-cadherin loss/aberrant expression and/or p120 cytoplasmic relocalization and/or CDH1 alteration; * HR-negative (ER \<1% and PR \<1%) or HR-low (ER and/or PR 1-10%) disease, as defined by ASCO/CAP guidelines, is eligible regardless of HER2 status (assessed according to 2025 ASCO/CAP criteria, with HER2-low and HER2-ultralow status recorded where assessable); * HR-positive (ER\>10% according to the ASCO/CAP guidelines) ILC is eligible only if HER2 status is positive; * Mixed ductal-lobular carcinomas are eligible provided that a clearly identified invasive lobular component is present and predominant (\>50% lobular) and HR-negative/low criteria are met; * Stage I-III disease at diagnosis; Patients with de novo stage IV disease who underwent surgery of the primary tumor will not be included in the main study cohort but may be captured in a separate exploratory cohort for dedicated analysis; * Patients who underwent surgery of the primary tumor at the participating institution, either upfront or after neoadjuvant systemic treatment; * Diagnosis occurred between 1 January 2000 and 31 December 2025; * Minimum follow-up of 12 months for patients without an event, unless recurrence or death occurred earlier; * Local review by a dedicated breast pathologist to confirm the diagnosis and the related molecular features, with particular attention to the confirmation of apocrine morphology. Exclusion Criteria: * Pure IC NST without any lobular invasive component; * ER or PR expression \>10% in the invasive component, in cases with negative HER2 status; * In situ lobular neoplasia (lobular carcinoma in situ) without an invasive component; * De novo stage IV disease (such patients, if they underwent surgery of the primary tumor, will be captured in a separate exploratory cohort for a dedicated analysis) * Synchronous invasive BC of another dominant histology requiring systemic treatment that precludes attribution of outcomes to HR-negative/low ILC; * Prior invasive BC under active systemic treatment at the time of diagnosis, unless clearly documented as unrelated and not expected to confound outcomes; * Insufficient data or follow up

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

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

  • Veneto Institute of Oncology

    RECRUITING

    Padova, Italy

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