New drug combo aims to boost breast cancer remission before surgery
NCT ID NCT07178171
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
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 30 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Nov 2025
- Expected to finish
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Aug 2030
An estimate. End dates often move.
- Lead sponsor
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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
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18 to 70 years
- Sex
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Female participants only
- 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: 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.
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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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Xijing hospital
RECRUITINGXi'an, Shaanxi, 710032, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can Real-World data match trial results for pembrolizumab in Triple-Negative breast cancer?
- Can Gene-Edited immune cells tame Hard-to-Treat cancers?
- Can a One-Time Anti-Inflammatory shot during surgery curb Triple-Negative breast Cancer's return?
- Triple-Drug cocktail aims to stall aggressive breast cancer
- Could a vaccine stop Triple-Negative breast cancer from coming back?
- Engineered immune cells take aim at Mesothelin-Positive tumors