A Prospective, Multicenter, Phase II Clinical Study of Postoperative Chemotherapy Combined With Q… (NCT07622836) | Clinical Trial Compass
RecruitingNot Applicable
A Prospective, Multicenter, Phase II Clinical Study of Postoperative Chemotherapy Combined With QL1706 for High-risk Triple-negative Breast Cancer.
China59 participantsStarted 2026-06-05
Plain-language summary
This study is a prospective, multicenter, phase II clinical trial designed to evaluate the efficacy and safety of postoperative chemotherapy combined with QL1706 in patients with high-risk triple-negative breast cancer.
After enrollment, participants will receive 8 cycles of chemotherapy combined with QL1706. The standard chemotherapy regimen is the AC-T regimen (4 cycles of epirubicin plus cyclophosphamide, followed by 4 cycles of a taxane) - a Category I recommendation in the 2025 CSCO guidelines. The final choice of chemotherapy regimen is at the investigator's discretion. Starting from cycle 9, participants will receive QL1706 monotherapy as maintenance treatment. Dosing will continue until protocol-defined treatment discontinuation criteria are met, the participant experiences intolerable toxicity, or the participant withdraws informed consent. The maximum number of QL1706 dosing cycles is 17.
After completing treatment, participants will continue to undergo post-treatment safety follow-up and survival follow-up. For participants who discontinue treatment for reasons other than disease progression or death, tumor progression follow-up will also be conducted after treatment ends.
After enrollment, safety assessments will be performed every 3 weeks, and imaging evaluations will be performed every 12 weeks (±7 days) until confirmed disease progression per RECIST v1.1, initiation of another new anti-cancer therapy, withdrawal of informed consent, or death, whichever occurs first.
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. The participant voluntarily joins this study and signs the informed consent form.
. Female breast cancer participants aged ≥18 and ≤75 years, with a histologically or cytologically confirmed diagnosis of TNBC (IHC 0, IHC 1+, or IHC 2+/ISH-) based on the most recent biopsy or other pathological specimen, according to the latest ASCO/CAP guidelines. Patients with low ER or PR expression (1%-10%) may also be included in this study.
. Patients with high-risk TNBC (defined as lymph node-positive).
. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
. Agree to provide intraoperatively obtained tumor histopathological specimens (FFPE, at least 5 sections) for biomarker testing.
. Expected survival ≥3 months.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
3-year disease-free survival rate (DFS%)
Timeframe: within a 3-year follow-up period
Trial details
NCT IDNCT07622836
SponsorThe First Affiliated Hospital with Nanjing Medical University
. Function of vital organs meets the following requirements (use of any blood components or cell growth factors within 14 days before the first dose is not allowed):
. Female participants who are not surgically sterilized or are of childbearing potential must use a medically approved contraceptive method (such as an intrauterine device, contraceptive pill, or condom) during the study treatment period and for 3 months after the end of the study treatment. Female participants of childbearing potential who are not surgically sterilized must have a negative serum or urine HCG test within 7 days before the first dose and must not be lactating.
Exclusion criteria
. Presence of any active autoimmune disease or history of autoimmune disease (e.g., including but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hypophysitis, vasculitis, nephritis, hyperthyroidism); however, participants with the following conditions are allowed to enroll: vitiligo, psoriasis, alopecia not requiring systemic treatment; well-controlled type I diabetes mellitus; hypothyroidism stable on hormone replacement; childhood asthma that has completely resolved and requires no intervention in adulthood; asthma requiring bronchodilators for medical intervention is excluded.
. Current use of immunosuppressants or systemic corticosteroid therapy for immunosuppressive purposes (dose \>10 mg/day prednisone or equivalent) within 2 weeks prior to enrollment.
. History of severe hypersensitivity reaction to other monoclonal antibodies.
. Prior discontinuation of anti-PD-1/PD-L1 antibody therapy due to related toxicity.
. Known history or evidence of interstitial lung disease or active non-infectious pneumonitis.
. History of CNS metastases or current central nervous system (CNS) metastases. Baseline imaging to rule out brain metastases is not mandatory. Patients with unknown CNS metastasis status but with any clinical signs suggestive of CNS metastases are eligible only if CT and/or MRI scans rule out CNS metastases.
. Previous history of other malignancies (except for patients with non-melanoma skin cancer or carcinoma in situ of the cervix, who are eligible; patients with other prior malignancies must have been disease-free for at least 3 years).
. Hypertension poorly controlled with antihypertensive medication (systolic blood pressure ≥140 mmHg or diastolic blood pressure ≥90 mmHg); achieving the above parameters with antihypertensive treatment is allowed. History of hypertensive crisis or hypertensive encephalopathy.