New combo aims to wipe out breast cancer before surgery
NCT ID NCT06967103
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.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 238 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Sep 2025
- Expected to finish
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May 2029
An estimate. End dates often move.
- Lead sponsor
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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
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
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Henan cancer hospital
RECRUITINGZhengzhou, China
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