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Antifungal drug could boost immunotherapy for tough breast cancer

NCT ID NCT06802757

Disease control Sponsor: Shandong Cancer Hospital and Institute 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests whether adding an antifungal drug (posaconazole) to standard immunotherapy and chemotherapy can help more women with triple-negative breast cancer achieve a complete response before surgery. About 72 women with early-stage, high-risk disease will be randomly assigned to receive either the standard treatment or the standard treatment plus posaconazole. The main goal is to see if the combination increases the rate of tumor disappearance.

What this could mean

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

Active substance
Posaconazole (an antifungal drug) combined with PD-1 inhibitors (immunotherapy) and chemotherapy
What this could lead to
If this works, it could increase the number of patients whose tumors completely disappear before surgery, potentially improving long-term outcomes for triple-negative breast cancer.
What could go wrong
This is a small, early-phase (Phase 2) trial with only 72 participants. The added benefit of posaconazole is unproven in humans for this purpose, and side effects from the combination are unknown.

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.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 72 people

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

Started

May 2025

Expected to finish

Feb 2028

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.

Ages

18 to 70 years

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: 1. Female, aged ≥ 18 and ≤ 70 years old; 2. first-confirmed TNBC; 3. cT1cN1-3M0 or cT2-4N0-3M0; 4. ECOG score 0-1 points. Exclusion Criteria: 1. Stage I or IV; 2. History of previous breast cancer; 3. Patients with a history of other tumors who have received systemic therapy or local radiotherapy; 4. No immune system disease or connective tissue disease; 5. No history of hormone therapy; 6. Pregnant/lactating.

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Conditions

The condition(s) this trial relates to.

breast cancer breast neoplasm triple-negative breast carcinoma

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

  • Breast Cancer Center Shandong Cancer Hospital and Institute Shandong First Medical University and Shandong Academy of Medical Sciences

    RECRUITING

    Jinan, Shandong, 250117, China

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