Actively Recruiting
QL1706 Plus Chemotherapy as Neoadjuvant Therapy in Triple-Negative Breast Cancer
Led by Affiliated Hospital of Nantong University · Updated on 2026-03-02
30
Participants Needed
1
Research Sites
147 weeks
Total Duration
On this page
AI-Summary
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.
CONDITIONS
Official Title
QL1706 Plus Chemotherapy as Neoadjuvant Therapy in Triple-Negative Breast Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically or cytologically confirmed newly diagnosed ER-/HER2- breast cancer with specific receptor negativity
- Clinical stage II or III breast cancer eligible for neoadjuvant chemotherapy aiming for complete surgical removal
- Tumor size of 2 cm or larger by clinical or imaging assessment; lymph node involvement allowed
- No prior cancer treatment (treatment-nafve subjects)
- Age 18 years or older; both genders eligible
- ECOG performance status of 0 or 1
- Adequate bone marrow, heart, and organ function
- Negative pregnancy test within 30 days before enrollment for women of childbearing potential and use of effective contraception during the study
- Ability to understand and provide written informed consent
You will not qualify if you...
- History of invasive cancers within 5 years except certain treated skin cancers or cervical carcinoma in situ
- Received chemotherapy, immunotherapy, targeted therapy, or radiotherapy within the past 12 months
- Stage IV metastatic breast cancer
- Received a vaccine within 30 days before starting study treatment
- Severe systemic diseases
- Active infections including HIV, hepatitis B or C, or tuberculosis
- Severe cardiovascular diseases such as recent heart attack, acute coronary syndrome, recent coronary procedures, or heart failure of NYHA class II-IV
- Lactating women who cannot stop breastfeeding during the study
- Known allergies to study drug or its components
- Any other condition considered unsuitable for study participation by the investigator
AI-Screening
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Trial Site Locations
Total: 1 location
1
Affiliated Hospital of Nantong University
Nantong, Jiangsu, China
Actively Recruiting
Research Team
L
Liu Fan
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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