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New drug combo aims to boost breast cancer remission before surgery

NCT ID NCT07178171

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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

Summary

This early-phase study tests a new immunotherapy drug (QL1706) combined with short cycles of chemotherapy in 30 people with early-stage triple-negative breast cancer. The goal is to see if this approach can eliminate all signs of cancer before surgery. Participants receive either a taxane or an anthracycline chemo alongside the immunotherapy, and those who still have cancer after initial treatment get additional cycles.

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 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 30 people

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

Started

Nov 2025

Expected to finish

Aug 2030

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 patients aged ≥18 and ≤70 years with newly diagnosed invasive breast cancer. 2. Triple-negative breast cancer (TNBC) with clinical stage cT2-T4 and cN0-cN3. 3. Unilateral disease. 4. No prior chemotherapy or immunotherapy for invasive breast cancer. 5. ECOG performance status of 0-1. 6. Adequate renal, hepatic, cardiovascular, and bone marrow function. 7. The patient voluntarily participates and signs the informed consent form. 8. According to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1, patients should have measurable tumor lesion. 9. Estimated life expectancy ≥6 months 10. Female subjects enrolled must be surgically sterilized, postmenopausal, or agree to use at least one medically acceptable method of contraception (e.g., intrauterine device \[IUD\], oral contraceptives, or condoms) during study treatment and for 6 months after the end of study treatment. The serum or urine pregnancy test within 7 days prior to enrollment must be negative, and the subject must not be breastfeeding. 11. Able to comply with study and follow-up procedures and willing to adhere to the visit schedule and the prohibitions and restrictions specified in the protocol. Exclusion Criteria: 1. History of invasive malignant tumor within ≤5 years prior to signing the informed consent form, except for adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix. 2. History of autoimmune disease; 3. Active hepatitis B or C virus infection, except for hepatitis B virus carriers or patients stabilized after antiviral therapy, who may be enrolled if HBV DNA titer is ≤500 IU/mL or \<2500 copies/mL. Active hepatitis C is defined as known HCV antibody positivity with a known HCV RNA quantitative result above the lower limit of detection of the assay. 4. Presence of any active infection requiring systemic therapy. 5. Currently using corticosteroids or immunosuppressive agents. 6. Prior treatment with immune checkpoint inhibitors. 7. Presence of psychiatric disorders or other conditions that may affect patient compliance. 8. Known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation. 9. Pregnant or breastfeeding female patients. 10. Known allergy to the investigational drugs used in this study or their components. 11. Any other condition that, in the opinion of the investigator, makes the patient unsuitable for participation in this clinical trial.

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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

  • Xijing hospital

    RECRUITING

    Xi'an, Shaanxi, 710032, China

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