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New combo aims to wipe out breast cancer before surgery

NCT ID NCT06967103

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 study tests whether adding the drug QL1706 to standard chemotherapy before surgery can eliminate more cancer in people with early HR+/HER2- breast cancer. About 238 participants will receive either the combination or chemo alone for 6 cycles, then have surgery. After surgery, they continue QL1706 for up to 6 months. The main goal is to see if no cancer remains in the removed tissue.

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 238 people

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

Started

Sep 2025

Expected to finish

May 2029

An estimate. End dates often move.

Lead sponsor

A government agency

The lead sponsor is a government body.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

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 Subjects meeting all of the following criteria are eligible for inclusion in this study: Voluntarily participates in the study, signs the informed consent form, and demonstrates good compliance. Female, aged ≥18 years . Evaluated by the research center as eligible to tolerate and scheduled to undergo radical breast cancer surgery, with no prior systemic anti-tumor therapy for breast cancer. cT2 - T4d N0-N3, or cT1c with axillary lymph node metastasis confirmed clinically and pathologically; Histologically and/or cytologically confirmed hormone receptor-positive (HR+) breast cancer (estrogen receptor \[ER\] or progesterone receptor \[PR\] nuclear staining \>1%) with Ki67 ≥20%. HER2-negative breast cancer, defined as: Negative in situ hybridization (ISH) results; or Immunohistochemistry (IHC) status of 0, 1+, or 2+. If IHC is 2+, ISH (e.g., FISH, CISH, SISH) must be negative. Willing to provide fresh or archived tumor tissue samples. At least one measurable lesion per RECIST 1.1 criteria. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1. Adequate organ function, defined as: Hematology: Hemoglobin ≥90 g/L Absolute neutrophil count ≥1.5 × 10⁹/L Platelet count ≥100 × 10⁹/L. Biochemistry: ALT and AST ≤2.5 × ULN (≤5 × ULN if liver metastases present); Total bilirubin ≤1.5 × ULN; Serum creatinine ≤1.5 × ULN or creatinine clearance (CCr) ≥60 mL/min. Coagulation: Activated partial thromboplastin time (APTT) ≤1.5 × ULN; International normalized ratio (INR) ≤1.5 × ULN. Cardiac function: Left ventricular ejection fraction (LVEF) ≥50% by echocardiography. Premenopausal or perimenopausal subjects must agree to use reliable and effective contraception or practice abstinence from the time of informed consent until at least 90 days after the last dose of study treatment. Exclusion Criteria Subjects meeting any of the following criteria will be excluded from this study: Known severe hypersensitivity to macromolecular protein preparations, QL1706, albumin-bound paclitaxel, epirubicin hydrochloride, or their excipients. Stage IV metastatic breast cancer or other conditions deemed ineligible for curative surgery after neoadjuvant therapy by the investigator. Inflammatory breast cancer or bilateral primary breast cancer (including invasive or in situ carcinoma). Major surgery or significant trauma within 28 days prior to the first dose. Administration of live attenuated vaccines within 28 days before the first dose or anticipated during the study. Systemic corticosteroids or immunosuppressive therapy within 14 days prior to the first dose or anticipated during the study. Active autoimmune disease requiring systemic treatment within 2 years prior to enrollment, or history of autoimmune disorders. Severe systemic infection within 28 days or active infection requiring intravenous/oral antibiotics within 14 days prior to the first dose. Prior organ or allogeneic bone marrow transplantation or awaiting transplantation. History or evidence of interstitial lung disease or active non-infectious pneumonitis. Bleeding tendency or high risk of hemorrhage. Thromboembolic events (e.g., cerebrovascular accident, pulmonary embolism) within 6 months prior to enrollment. Congenital or acquired immunodeficiency (e.g., HIV infection). Active hepatitis: Hepatitis B: HBsAg-positive with HBV DNA ≥2000 IU/mL; Hepatitis C: HCV antibody-positive with HCV RNA above the upper limit of normal. Poorly controlled cardiac conditions, including: NYHA Class II or higher heart failure or LVEF \<50%; Unstable angina; Myocardial infarction within 1 year; QTc interval \>470 ms (female) on resting ECG. Other malignancies within 5 years (excluding basal cell carcinoma or cervical carcinoma in situ). Use of investigational drugs within 4 weeks prior to the first dose. History or current diagnosis of neurological or psychiatric disorders (e.g., epilepsy, dementia). History of pancreatitis. Pregnancy, lactation, or refusal to use contraception. Any other condition deemed inappropriate for participation by the investigator.

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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

  • Henan cancer hospital

    RECRUITING

    Zhengzhou, China

More trials for these conditions

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