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Tests treatment safety and results for Triple-negative Breast Cancer
Official title A Study on the Efficacy and Safety of Oral All-trans Retinoic Acid Combined With Toripalimab in TNBC.
ClinicalTrials.gov ID: NCT06371274
What this study is testing
What is ATRA?
ATRA is an investigational medicine, given as a twice-daily infusion into a vein, being studied as a potential treatment for triple-negative breast cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, women only
You may be able to join if
- Age ≥18 years at the time of signing the informed consent form;
- Pathologically confirmed as triple-negative breast cancer based on recent biopsy or other pathological specimens, with histological and/or...
- Patients with unresectable locally advanced or metastatic triple-negative breast cancer who have failed at least second-line standard treatment...
- 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;
- Adequate organ and bone marrow function (not received blood transfusions, recombinant human platelet growth factor, or colony-stimulating factor...
You likely can't join if
- Known symptomatic or uncontrolled brain metastasis or other central nervous system (CNS) metastases;
- Patients with other malignant tumors, excluding those with cured basal cell or squamous cell skin carcinoma or in situ cervical cancer. Patients with...
- Any severe and/or uncontrolled concurrent illness that hinders the patient's participation in the study;
- History of immunodeficiency, autoimmune diseases, the need for immunosuppressive therapy (daily dose \>10 mg of prednisone or equivalent), or a...
- History of deep vein thrombosis or pulmonary embolism;
- Severe osteoporosis or patients with bone metastases;
See the full eligibility criteria
- Age ≥18 years at the time of signing the informed consent form;
- Pathologically confirmed as triple-negative breast cancer based on recent biopsy or other pathological specimens, with histological and/or cytological diagnosis;
- Patients with unresectable locally advanced or metastatic triple-negative breast cancer who have failed at least second-line standard treatment regimens;
- 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;
- 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);
- 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.
- Known symptomatic or uncontrolled brain metastasis or other central nervous system (CNS) metastases;
- 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...
- Any severe and/or uncontrolled concurrent illness that hinders the patient's participation in the study;
- History of immunodeficiency, autoimmune diseases, the need for immunosuppressive therapy (daily dose \>10 mg of prednisone or equivalent), or a history of chronic infections;
- History of deep vein thrombosis or pulmonary embolism;
- Severe osteoporosis or patients with bone metastases;
- 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...
- Patients with active hepatitis B or C; known history of human immunodeficiency virus (HIV) infection or acquired immunodeficiency syndrome (AIDS); positive syphilis antibody test;
- History of severe drug allergies or known allergy to any component of the investigational drug as per the prescription;
- The investigator considers the participant unsuitable for the study.
The study team makes the final eligibility decision.
Where it's taking place
- Hangzhou, Zhejiang Province, P.R. China, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Hangzhou, Zhejiang Province, P.R. China, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.