QL1706 with chemotherapy before surgery for triple-negative breast cancer

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 is a single-center, single-arm, prospective Phase 2 study enrolling 30 patients with newly diagnosed stage II–III triple-negative breast cancer. Participants receive four 21-day cycles of QL1706 combined with carboplatin and albumin-bound paclitaxel, followed by four 21-day cycles of QL1706 combined with doxorubicin or epirubicin plus cyclophosphamide. The main outcome measured is the pathological complete response (pCR) rate at the time of surgery, and patients are followed for one year after treatment. Eligible patients are treatment-naïve adults with ER-/HER2- tumors that are at least 2 cm or have confirmed/clinically palpable lymph node involvement.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Histologically or cytologically confirmed newly diagnosed ER-/HER2- breast cancer. ER and PR with Allred score \<3 or \<1% positively stained cells in tumor infiltrating components. HER2 negativity defined as 0 or 1+ by FISH or IHC staining per NCCN guidelines;
2. Clinical stage II or III breast cancer eligible for neoadjuvant chemotherapy (per AJCC 8th edition: at least T2 any N M0, or any T if N+), with treatment goal of complete surgical resection following neoadjuvant therapy;
3. Tumor size ≥2 cm by clinical or imaging assessment per WHO criteria. Patients with histologically confirmed or clinically palpable lymph nodes are eligible regardless of tumor size;
4. Treatment-naïve subjects;
5. Age ≥18 years, both genders eligible;
6. ECOG performance status 0-1;
7. Adequate bone marrow, cardiac, and organ function;
8. Women of childbearing potential must have a negative pregnancy test (serum or urine HCG) within 30 days prior to study enrollment and must practice effective contraception during the study;
9. Ability to comprehend and provide written informed consent.

Exclusion Criteria:

1. History of invasive malignancies within 5 years prior to signing the informed consent form, except for adequately treated basal cell carcinoma, squamous cell skin cancer, or carcinoma in situ of the cervix;
2. Subjects who have received chemotherapy, immunotherapy, targeted therapy, or radiotherapy within the past 12 months;
3. Stage IV metastatic breast cancer;
4. Administration of a vaccine within 30 days before the first dose of the study treatment;
5. Subjects with severe systemic diseases;
6. Subjects with active infections (including but not limited to HIV, hepatitis B or C, tuberculosis);
7. Severe cardiovascular diseases, such as: history of myocardial infarction, acute coronary syndrome, or coronary angioplasty/stenting/bypass grafting within the past 6 months; or congestive heart failure (CHF) of New York Heart Association (NYHA) class II-IV, or history of CHF NYHA class III or IV;
8. Lactating women should discontinue breastfeeding during the study;
9. Subjects with known allergies to the study drug or any of its excipients;
10. Any other condition deemed inappropriate for participation in the study by the investigator.

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Where it's running

• Affiliated Hospital of Nantong University
  Nantong, Jiangsu, China Recruiting

Study contacts

• Study coordinator: Liu Fan
• Email: lflove2009@126.com
• Phone: 86+18912250939

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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.