Actively Recruiting
Efficacy and Safety Study of Oral All-trans Retinoic Acid Combined With Toripalimab in Patients With Inoperable Locally Advanced, Recurrent, or Metastatic Triple-negative Breast Cancer Who Had Failed Prior Second-line or Higher Standard Therapy
Led by First Affiliated Hospital of Zhejiang University · Updated on 2025-08-12
29
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
F
First Affiliated Hospital of Zhejiang University
Lead Sponsor
S
Shanghai Longfine Biotechnology Co., Ltd.
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the clinical effects and safety of combining oral all-trans retinoic acid with toripalimab in women with advanced triple-negative breast cancer that cannot be removed by surgery, has returned, or spread to other parts of the body after failing standard second-line or later treatments. This study is a single-arm, open-label trial conducted at one center, aiming to enroll 32 participants to better understand this combination therapy in this patient group. Participants will take all-trans retinoic acid orally at a dose of 150 mg/m2 twice daily for three consecutive days in each 3-week cycle. On day 1 of each cycle, they will also receive an intravenous infusion of toripalimab at 240 mg. Treatment cycles continue every three weeks until the disease worsens, unacceptable side effects occur, loss to follow-up, death, or other withdrawal reasons, for up to two years. The study includes a screening period up to 28 days to confirm eligibility and baseline assessments. During treatment, tumor scans using contrast-enhanced CT will be done every 6 weeks to evaluate response using RECIST 1.1 and iRECIST criteria. Safety will be monitored by observing side effects according to standard criteria up to 30 days after the last treatment. After treatment ends, participants will be followed for survival every three months to measure outcomes including response rate, progression-free survival, duration of response, and overall survival, with total follow-up up to two years.
CONDITIONS
Brief Title
A Study on the Efficacy and Safety of Oral All-trans Retinoic Acid Combined With Toripalimab in TNBC.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female patients aged 18 years or older at the time of informed consent
- Pathologically confirmed triple-negative breast cancer by recent biopsy or pathological specimen
- Locally advanced, unresectable or metastatic triple-negative breast cancer
- Failed at least second-line standard treatment regimens
- At least one measurable lesion according to RECIST 1.1 (excluding only skin or bone lesions)
- Adequate organ and bone marrow function without recent blood transfusions or growth factor treatments
- Able and willing to comply with study procedures and provide informed consent
You will not qualify if you...
- Known symptomatic or uncontrolled brain or central nervous system metastases
- Presence of other malignant tumors except cured basal cell or squamous cell skin cancer or in situ cervical cancer with at least 5 years disease-free
- Severe or uncontrolled illnesses that interfere with study participation
- History of immunodeficiency, autoimmune disease, or need for high-dose immunosuppressive therapy
- History of deep vein thrombosis or pulmonary embolism
- Severe osteoporosis or bone metastases
- Recent chemotherapy, immunotherapy, biologic therapy, radiotherapy, major surgery, or participation in other drug trials within specified timeframes before study treatment
- Active hepatitis B or C, HIV infection, AIDS, or positive syphilis test
- History of severe drug allergies or allergy to study drug components
- Investigator assessment of unsuitability for the study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - Within 28 days
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit
Duration - Up to 2 years
Participants take oral all-trans retinoic acid twice a day for three consecutive days per cycle and receive intravenous infusion of toripalimab on day 1 of each 3-week cycle. This continues until disease progression, intolerable toxicity, loss to follow-up, or withdrawal criteria are met, for up to 2 years.
Visits every 3 weeks for treatment; tumor assessments every 6 weeks
Duration - Up to 30 days after last treatment with survival follow-up every 3 months
Participants are followed every 3 months after completing treatment to monitor survival and safety for up to 30 days after the last treatment.
Follow-up visits every 3 months
Trial Site Locations
Total: 1 location
1
The first affiliated hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang Province, P.R. China, China, 310003
Actively Recruiting
Research Team
J
Jian Liu, MS
M
Meihua Lin, MS
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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