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Can a Four-Drug combo erase Triple-Negative breast cancer before surgery?

NCT ID NCT06910072

Disease control Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical 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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 13, 2026 · Last updated Aug 19, 2026 · Updated 3 times

Summary

This trial is testing whether combining chemotherapy with two immunotherapy drugs, given before surgery, can completely eliminate triple-negative breast cancer in people with stage II-III disease. Participants will receive six cycles of the combination, and the main goal is to see how many achieve a pathological complete response (no cancer cells left in the removed tissue). The study also tracks side effects and long-term outcomes like event-free survival.

What this could mean

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

Active substance
A combination of chemotherapy (paclitaxel polymeric micelles and carboplatin) and two immunotherapy drugs (iparomilimab and tuvonralimab) given before surgery.
What this could lead to
If successful, this approach could increase the chance of eliminating the tumor before surgery, potentially improving long-term outcomes for people with triple-negative breast cancer.
What could go wrong
This is an early-phase study with a small number of participants, so results may not be conclusive. The combination may cause significant side effects, and the benefit over standard treatment is not yet proven.

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 2/3

Runs two stages together: whether the treatment works, then large-scale confirmation.

Participants

About 32 people

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

Started

Jul 2025

Expected to finish

Oct 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 75 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: * Triple-negative breast cancer * The diameter of the primary tumor must be greater than 2cm, and the clinical stage should be II-III * There is sufficient primary organ function * The ECOG (PS) score is 0 or 1 * Expected survival ≥ 6 months * The serum pregnancy test was negative. Use highly effective methods of contraception during the study period and for 180 days after the last dose of the study drug, and do not breastfeed Exclusion Criteria: * Bilateral breast cancer * There is a history of ductal carcinoma in situ (DCIS) or lobular carcinoma in situ (LCIS) * A history of invasive or metastatic breast cancer * Any malignancy diagnosed within 5 years, excluding cured cervical carcinoma in situ, skin basal cell carcinoma, or squamous cell carcinoma * There is an immune deficiency disease * The presence of any autoimmune disease that still requires treatment or a history of prior autoimmune disease

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Conditions

The condition(s) this trial relates to.

triple-negative breast carcinoma

As listed by the trial registrant

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

Neoadjuvant therapy Triple negative breast cancer (TNBC)

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

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

    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

  • Cancer Hospital, Chinese Academy of Medical Sciences

    Beijing, 100021, China

More trials for these conditions

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