This study is a single-arm, multicenter, prospective phase II clinical trial designed to evaluate the efficacy and safety of QL1706 in combination with anlotinib hydrochloride and nab-paclitaxel as first-line treatment for advanced triple-negative breast cancer.
A total of 34 participants with first-line advanced triple-negative breast cancer are enrolled in this study:
Enrolled participants receive QL1706 (5 mg/kg, Q3W, day 1) + anlotinib (12 mg per dose, QD, days 1-14, Q3W) + nab-paclitaxel (125 mg/m², days 1 and 8, Q3W), with a 21-day cycle. Treatment continues until disease progression, intolerable toxicity, the investigator's judgment that the participant no longer derives benefit, withdrawal of informed consent by the participant, completion of 2 years of QL1706 treatment, or other reasons specified in the protocol.
The study consists of a screening period (from the signing of informed consent to no more than 28 days before the first dose), a treatment period (including on-treatment visits and end-of-treatment visit), and a follow-up period (including safety follow-up and survival follow-up).
Screening Period:
The screening period begins after the participant signs the informed consent form and ends at enrollment, lasting no more than 28 days. Eligible participants are those with pathologically confirmed, previously untreated first-line triple-negative breast cancer. During screening, participant information, samples, and blood specimens are collected as needed. Participants who meet all inclusion criteria and none of the exclusion criteria are enrolled.
Treatment Period:
Study drugs are administered within 3 days of enrollment. Each treatment cycle is 3 weeks. Study treatment continues until disease progression, intolerable toxicity, initiation of new anti-cancer therapy, loss to follow-up, death, withdrawal of informed consent, or other reasons, with a maximum treatment duration of 2 years (whichever occurs first). Safety assessments are performed every 3 weeks, and tumor imaging evaluations are performed every 6 weeks (±7 days) according to RECIST v1.1 criteria.
Follow-up Period:
When participants discontinue study treatment or withdraw early, they are still required to complete the corresponding assessments as specified in the protocol.
Safety Follow-up: At 30 days (±7 days) after the last dose, participants return to the site for one follow-up visit, during which blood samples are collected and safety examinations are performed.
Survival Follow-up: Every 2 months. Survival status and subsequent treatment information are collected by telephone or other appropriate means.
Participants voluntarily join the study, sign the informed consent form, and agree to strictly comply with the study protocol requirements.
Female patients aged between 18 and 75 years.
Confirmed by histopathological examination as advanced triple-negative invasive breast cancer, meeting the following criteria: pathological type triple-negative, specifically: ER negative (IHC <1%), PR negative (IHC <1%), HER2 negative (IHC -/+ or IHC ++ but FISH/CISH negative). Priority is given to pathology from metastatic lesions; if metastatic lesion pathology is not available, primary lesion pathology may be used.
TNBC patients with initial diagnosis of stage IV (according to AJCC 8th edition) or recurrent/metastatic disease who are not suitable for surgery, and have not received prior systemic therapy for advanced disease. Prior neoadjuvant and/or adjuvant therapy with taxanes or other anti-tumor treatments is permitted, provided that there was no disease progression during neoadjuvant therapy, and the interval between completion of taxane-based (neo)adjuvant therapy and recurrence/metastasis is ≥6 months.
Known history of severe allergic reactions to QL1706, anlotinib, nab-paclitaxel, or any of their excipients.
Inability to swallow oral medications, or any gastrointestinal disorder that may interfere with the absorption and metabolism of the study drugs.
Symptomatic brain/leptomeningeal metastases and/or spinal cord metastases.
Active or potentially relapsing autoimmune disease, with the following exceptions: vitiligo, alopecia, psoriasis, or eczema not requiring systemic treatment; hypothyroidism due to autoimmune thyroiditis requiring only stable-dose hormone replacement therapy; type I diabetes mellitus requiring only stable-dose insulin replacement therapy.