QL1706 Plus Chemotherapy as Neoadjuvant Therapy in Triple-Negative Breast Cancer
Recruiting · NCT07342283 · Interventional (participants receive a specific treatment)
View the official record on ClinicalTrials.gov →Interventions studied
Immunotherapy combined with chemotherapy
What this trial is about
This is a single-center, single-arm, prospective study enrolling 30 patients with stage II-III triple-negative breast cancer. The neoadjuvant regimen consists of QL1706 combined with carboplatin plus albumin-bound paclitaxel (21-day cycles for 4 cycles) followed by QL1706 combined with doxorubicin/epirubicin plus cyclophosphamide (21-day cycles for 4 cycles). The treatment observation period is 1 year, and the primary endpoint is the pathological complete response rate.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 2
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- 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;
- 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;
- 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;
- Treatment-naïve subjects;
- Age ≥18 years, both genders eligible;
- ECOG performance status 0-1;
- Adequate bone marrow, cardiac, and organ function;
- 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;
- Ability to comprehend and provide written informed consent.
Exclusion criteria
- 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;
- Subjects who have received chemotherapy, immunotherapy, targeted therapy, or radiotherapy within the past 12 months;
- Stage IV metastatic breast cancer;
- Administration of a vaccine within 30 days before the first dose of the study treatment;
- Subjects with severe systemic diseases;
- Subjects with active infections (including but not limited to HIV, hepatitis B or C, tuberculosis);
- 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;
- Lactating women should discontinue breastfeeding during the study;
- Subjects with known allergies to the study drug or any of its excipients;
- Any other condition deemed inappropriate for participation in the study by the investigator.
Where it is running
1 location listed.
- Affiliated Hospital of Nantong University - Nantong, Jiangsu, China