Neoadjuvant therapy for early triple-negative breast cancer using QL1706 plus chemotherapy guided by response

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase 2 study investigates a bifunctional antibody combination, QL1706, given with standard neoadjuvant chemotherapy to women with early-stage triple-negative breast cancer. After four cycles of TP (docetaxel and carboplatin) or four cycles of AC (doxorubicin and cyclophosphamide), patients undergo imaging and biopsy to guide further treatment. Those with radiologic complete response proceed to surgery, while non-responders receive four more cycles of AC before surgery. The trial uses a response-guided neoadjuvant (RGN) model to identify patients who may avoid anthracyclines, aiming to reduce long-term cardiotoxicity. Primary goals include exploring tumor response rates and surgical outcomes, with safety and tolerability observed throughout.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Voluntarily join this study, sign the informed consent form, and demonstrate good compliance;
* Age: 18-75 years old (at the time of signing the informed consent form);
* ECOG PS score: 0-1; expected survival time exceeding 6 months;
* Patients with primary breast cancer confirmed by histopathological or cytological examination;
* Primary tumor diameter \> 2 cm as measured by local standard assessment methods;
* Judged by the investigator to meet the American Joint Committee on Cancer (AJCC) 8th edition breast cancer TNM staging criteria as cT2-cT4, cN0-cN3, cM0, with locally advanced or early-stage, unilateral, and histologically confirmed invasive breast cancer;
* According to the latest ASCO/CAP guideline definitions, histopathologically confirmed early-stage triple-negative invasive breast carcinoma meeting all of the following criteria:Tumors are triple-negative on pathological subtyping, defined as: ER-negative: IHC ≤10%; PR-negative: IHC ≤10%; HER2-negative: IHC 0/1+, or IHC 2+ with negative ISH.
* At least one measurable lesion according to RECIST 1.1;
* The patient agrees to undergo breast cancer resection surgery when meeting the surgical criteria after neoadjuvant therapy;
* PD-L1 expression status is known;
* Major organ functions are in good condition;
* Female subjects of childbearing potential must have a negative serum pregnancy test within 3 days prior to the first dose. If a female subject of childbearing potential engages in sexual activity with a non-sterilized male partner, the subject must use acceptable and effective contraception from screening onward and agree to continue these precautions until 12 months after the last dose of the study drug; periodic abstinence and rhythm methods are not acceptable contraceptive methods.
* The subject is willing to provide core needle biopsy tissue samples for research analysis.

Exclusion Criteria:

* Patients with stage IV metastatic breast cancer or other patients deemed by the investigator as unable to achieve curative surgical resection through neoadjuvant therapy;
* Patients with inflammatory breast cancer;
* Patients who have had or currently have other malignancies within the past 3 years. The following two conditions may be eligible: other malignancies treated with a single surgical procedure, achieving continuous 5-year disease-free survival (DFS); cured cervical carcinoma in situ, non-melanoma skin cancer, and superficial bladder tumors \[Ta (non-invasive tumor), Tis (carcinoma in situ), and T1 (tumor invading the basement membrane)\];
* Breast cancer patients who have received antitumor therapies such as chemotherapy, endocrine therapy, or immune checkpoint inhibitors within the past 3 years, or who have undergone breast surgery (except diagnostic biopsy for primary breast cancer);
* Patients who have undergone major surgical treatment, incisional biopsy, or significant traumatic injury within 28 days prior to the start of study treatment (except diagnostic biopsy for primary breast cancer);
* Presence of any active autoimmune disease or a history of autoimmune disease;
* Patients currently using immunosuppressants or systemic hormonal therapy for immunosuppressive purposes (at a dose \>10 mg/day prednisone or equivalent steroids) and continuing such treatment within 2 weeks prior to enrollment;
* Allergy to any study drug or any component or excipient of the drug;
* Patients with concomitant diseases judged by the investigator as seriously endangering the subject's safety or affecting study completion, or those deemed unsuitable for enrollment for other reasons.

Where it's running

• Tianjin Medical University Cancer Institute & Hospital
  Tianjin, China Recruiting

Study contacts

• Principal investigator: Jun Zhang — Tianjin Medical University Cancer Institute and Hospital
• Study coordinator: Yongsheng Jia, Doctor
• Email: yongshengjia@tjmuch.com
• Phone: +86 18622199359

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.