Recruiting NCT07342283
QL1706 Plus Chemotherapy as Neoadjuvant Therapy in Triple-Negative Breast Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Immunotherapy combined with chemotherapy.
- Who it may be relevant to
- Registry conditions: Triple Negative Breast Cancer (TNBC). Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Drug Immunotherapy combined with chemotherapy
Albumin-bound paclitaxel: 125 mg/m², day 1 and day 8, 21-day cycle; Carboplatin: AUC = 5, day 1 or AUC = 2-3, day 1 and day 8, 21-day cycle; QL1706: 5 mg/kg, day 1, 21-day cycle; Epirubicin: 90-100 mg/m², day 1, 21-day cycle; or Doxorubicin: 50 mg/m², day 1, 21-day cycle; Cyclophosphamide: 600 mg/m², day 1, 21-day cycle.
Primary outcome measures
- Pathologic complete response (pCR) rates [Time frame: Up to approximately 9 months]
Secondary outcome measures (4)
- Objective response rate（ORR） [Time frame: Up to approximately 27-30 weeks]
- 3y-EFS [Time frame: Up to approximately 3 years]
- Overall survival (OS) [Time frame: Up to approximately 8 years]
- Adverse events [Time frame: up to 18 months]
Eligibility criteria
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.
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Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- Affiliated Hospital of Nantong University — Nantong
Identifiers
NCT: NCT07342283 · 2025-K223-02