NCT06371274 A Study on the Efficacy and Safety of Oral All-trans Retinoic Acid Combined With Toripalimab in TNBC.
| NCT ID | NCT06371274 |
| Status | Recruiting |
| Phase | — |
| Sponsor | First Affiliated Hospital of Zhejiang University |
| Condition | Triple-negative Breast Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 29 participants |
| Start Date | 2024-10-10 |
| Primary Completion | 2026-04-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 29 participants in total. It began in 2024-10-10 with a primary completion date of 2026-04-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
To evaluate the clinical efficacy and safety of oral all-trans retinoic acid in combination with toripalimab in patients with locally advanced, recurrent, or metastatic triple-negative breast cancer who had failed second-line and subsequent therapy.
Eligibility Criteria
Inclusion Criteria: 1. Age ≥18 years at the time of signing the informed consent form; 2. Pathologically confirmed as triple-negative breast cancer based on recent biopsy or other pathological specimens, with histological and/or cytological diagnosis; 3. Patients with unresectable locally advanced or metastatic triple-negative breast cancer who have failed at least second-line standard treatment regimens; 4. According to RECIST 1.1, at least one measurable lesion is required. Patients with only skin lesions or bone lesions are not eligible for inclusion; 5. Adequate organ and bone marrow function (not received blood transfusions, recombinant human platelet growth factor, or colony-stimulating factor treatment in the 2 weeks before screening); 6. The subject voluntarily agrees to participate in this study, signs the informed consent form, and is able to comply with the visits and related procedures specified in the protocol. Exclusion Criteria: 1. Known symptomatic or uncontrolled brain metastasis or other central nervous system (CNS) metastases; 2. Patients with other malignant tumors, excluding those with cured basal cell or squamous cell skin carcinoma or in situ cervical cancer. Patients with other malignant tumors must have a disease-free interval of at least 5 years; 3. Any severe and/or uncontrolled concurrent illness that hinders the patient's participation in the study; 4. History of immunodeficiency, autoimmune diseases, the need for immunosuppressive therapy (daily dose \>10 mg of prednisone or equivalent), or a history of chronic infections; 5. History of deep vein thrombosis or pulmonary embolism; 6. Severe osteoporosis or patients with bone metastases; 7. Participants who, within the first 4 weeks before the initiation of the study treatment or during the 5 half-lives of any drugs used in the pre-study period (whichever is shorter), have received any chemotherapy, immunotherapy, biologic therapy, or participated in other drug clinical trials, or received traditional Chinese medicine preparations for the treatment of approved anticancer indications or radiotherapy within the first 2 weeks before the initiation of the study treatment, or have undergone major surgery within the first 4 weeks before the initiation of the study treatment; 8. Patients with active hepatitis B or C; known history of human immunodeficiency virus (HIV) infection or acquired immunodeficiency syndrome (AIDS); positive syphilis antibody test; 9. History of severe drug allergies or known allergy to any component of the investigational drug as per the prescription; 10. The investigator considers the participant unsuitable for the study.
Contact & Investigator
Xiaochen Zhang, MD
PRINCIPAL INVESTIGATOR
Zhejiang University
Frequently Asked Questions
Who can join the NCT06371274 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Triple-negative Breast Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06371274 currently recruiting?
Yes, NCT06371274 is actively recruiting participants. Contact the research team at lindaliu87@zju.edu.cn for enrollment information.
Where is the NCT06371274 trial being conducted?
This trial is being conducted at Hangzhou, China.
Who is sponsoring the NCT06371274 clinical trial?
NCT06371274 is sponsored by First Affiliated Hospital of Zhejiang University. The principal investigator is Xiaochen Zhang, MD at Zhejiang University. The trial plans to enroll 29 participants.
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